key: cord-0998097-nhw5oqrl
authors: Bartier, Sophie; Croix, Candice La; Evrard, Diane; Hervochon, Rémi; Laccourreye, Ollivier; Gasne, Cassandre; Excoffier, Aude; Tanaka, Lei; Barry, Beatrix; Coste, André; Tankere, Frédéric; Kania, Romain; Nevoux, Jérôme
title: Tracheostomies after SARS-CoV-2 intubation, performed by academic otorhinolaryngologists in the Paris area of France: preliminary results
date: 2021-03-04
journal: Eur Ann Otorhinolaryngol Head Neck Dis
DOI: 10.1016/j.anorl.2021.03.002
sha: cd8ee52ec5a182d9c467c6b560236bdc09b863e8
doc_id: 998097
cord_uid: nhw5oqrl

Objective: To analyze tracheostomies after intubation for SARS-Cov-2 infection performed by otorhinolaryngologists in 7 university hospitals in the Paris area of France during the month March 24 to April 23, 2020. Material and Methods: A multicenter retrospective observational study included 59 consecutive patients. The main goals were to evaluate the number, characteristics and practical conditions of tracheostomies, and the Covid-19 status of the otorhinolaryngologists. Secondary goals were to analyze tracheostomy time, decannulation rate, immediate postoperative complications and laryngotracheal axis status. Results: Tracheostomy indications were for ventilatory weaning and extubation failure in 86% and 14% of cases respectively. The technique was surgical, percutaneous or hybrid in 91.5%, 3.4% and 5.1% of cases respectively. None of the operators developed symptoms consistent with Covid-19. Postoperative complications occurred in 15% of cases, with no significant difference between surgical and percutaneous/hybrid techniques (p=0.33), although no complications occurred after percutaneous or hybrid tracheostomies. No procedures or complications resulted in death. The decannulation rate was 74.5% with a mean tracheostomy time of 20±12 days. In 55% of the patients evaluated by flexible endoscopy after decannulation, a laryngeal abnormality was found. On univariate analysis, no clinical features had a significant influence on tracheostomy time, decannulation rate or occurrence of laryngeal lesions. Conclusion: The main findings of the present retrospective study were: absence of contamination of the surgeons, heterogeneity of practices between centers, a high rate of complications and laryngeal lesions whatever the technique, and the specificities of the patients.

On January 24, 2020, the first 3 cases of SARS-Cov-2 (severe acute respiratory syndrome coronavirus-2) in France were diagnosed. In hospitals, the subsequent epidemic led to an exponential rise in the number of patients requiring mechanical ventilation. In order to facilitate withdrawal of mechanical ventilation, free up hospital beds and alleviate workload in intensive care, intensivists proposed tracheostomy and in some cases called on ORL surgeons for this, as had been done in the East of France and in Italy a few weeks before [1, 2] On March 21, 2020, the French Society of Otorhinolaryngology (SFORL) published recommendations entitled "Covid-19 Alert: ORL Endoscopy and Flexible Endoscopy, Endonasal Surgery, Tracheostomy and Tracheostomy Care" (https://www.sforl.org/wpcontent/uploads/2020/03/Alerte-Covid-19-Endoscopies-et-fibroscopies.pdf), followed up on April 14 by guidelines entitled "French consensus on tracheostomy and tracheostomy care during the COVID-19 pandemic" [3] . The main objectives of the present study in this context were to assess the number, characteristics and practical modalities of tracheostomies performed by academic ORL physicians in the Paris area of France in the month following the publication of the guidelines, and the Covid-19 status of the physicians. Secondary endpoints comprised procedure time, types and rate of immediate complications, tracheostomy duration, decannulation rate and laryngotracheal axis status at >1 month post-tracheostomy.

The multicenter retrospective observational study analyzed a cohort of 59 patients undergoing tracheostomy after intubation for SARS-Cov Endoscopy, Endonasal Surgery, Tracheostomy and Tracheostomy Care" (https://www.sforl.org/wp-content/uploads/2020/03/Alerte-Covid-19-Endoscopies-etfibroscopies.pdf)).

Covid-19 was diagnosed on positive RT-PCR and/or typical chest CT [4] . Cases of acute respiratory distress not involving Covid-19 intubated during the study period were excluded, as were tracheostomies performed exclusively by intensivists without ORL help. Table 1 with Covid-19 infection, with or without nasopharyngeal sampling for PCR, and with or without serologic analysis, 1 month after the procedure.

Reasons for tracheostomy were to facilitate withdrawal of ventilation in 86% of cases (51/59) or for failure of a single attempted extubation in 14% (8/59). Critical illness neuromyopathy was observed in 30% of cases (15/59), taking all causes of tracheostomy together.

Tracheostomy was performed in theater in 51% of cases (30/59) and in the intensive care unit in 49% (29/59). Table 2 shows procedure modalities, including technique: surgery, percutaneous endoscopy, or hybrid ( Figure 2 ). In all cases, the procedure was conducted after complete sedation; in surgery, the intubation balloon was pushed beyond the intended tracheal opening, and ventilation was stopped ahead of the incision. In 12% of cases (7/59), a protective suit ("sarcophagus") was used as a supplementary protective interface ( Figure 3 ).

Given the large predominance of surgical tracheostomies (54/59), no statistical analysis of a correlation between technique (surgery, percutaneous endoscopy, hybrid) and clinical characteristics was attempted.

Tracheostomy was performed at a mean 20±6 days after diagnosis. Protective equipment included an FFP2 mask in 95% of cases (56/59); in the other 5% (3/59), a snorkeling mask equipped with an FFP2 filter was used. No operators developed symptoms compatible with Covid-19 infection or were diagnosed as positive on PCR or serology in the month following the procedure. 7 Intraoperative complications occurred in 17% of cases (10/59): hypoxia in 10% (6/59) and bleeding in 7% (4/59), without significant relation to technique (surgical or percutaneous/hybrid) (p=0.3). Postoperative complications occurred in 15% of cases (9/59): bleeding in 7% (4/59), infection in 7% (4/59) and tracheal orifice leak in 2% (1/59), without significant relation to technique (p=0.33), although none occurred after percutaneous or hybrid tracheostomy. None of these complications were fatal.

Six patients died (5 with surgical and 1 with percutaneous tracheostomy), including 4 before decannulation; causes of death did not implicate the tracheostomy.

Decannulation rate and laryngeal status were assessed in respectively 93.2% (55/59) and 34% of cases (20/59) ( Figure 3 ). Four of the 8 patients in whom decannulation was not assessed died before decannulation and 4 were lost to follow-up. Five of the 39 patients without laryngeal endoscopy died before the assessment could be made and the other 34 were lost to follow-up (transfer to rehabilitation or other departments).

The decannulation rate was 74.5 % (41/55), for a mean tracheostomy duration of 20±12 days. Laryngeal assessment was performed at a mean 69±29 days after intubation and 48±29 days after tracheostomy, and showed abnormalities in 55% of cases (11/20) Univariate analysis found no significant correlations between clinical characteristics (Table 1 ) and decannulation rate, or between reason for tracheostomy (withdrawal or extubation failure) and decannulation rate (p=0.095). Pearson linear correlation fond no association between tracheostomy duration and decannulation rate (-0.065; p=0.653).

Univariate analysis found no significant correlation between impaired laryngeal status and decannulation rate (Tables 3 and 4 ). (Table 5 ) and tracheostomy duration. Pearson linear correlation found no association between tracheostomy duration and BMI (0.206, p=0.075) or Charlson score (-0.075, p=0.647); tracheostomy duration, however, showed a tendency to increase with age (0.329, p=0.031).

The characteristics of the present population (Table 1 ) agreed with those of other intensive-care cohorts of Covid-19-related respiratory distress: predominance of >50 year-old males with cardiovascular comorbidity (obesity, high blood pressure, diabetes) [8, 9] .

Unexpectedly and unlike prior experience in eastern France and Italy [1, 2] , few patients underwent tracheostomy, whether by an ORL or non-ORL operator ( Table 2 ). There may be several reasons for this. Firstly, severity entailed high mortality in intensive care (20-60% depending on the report) [10] . Secondly, the difficulty of withdrawing oxygen support, often beyond 2 weeks, and mechanical ventilation modalities incompatible with tracheostomy (FiO2≥60%, PEP ≥12mmHg) limited indications [8] . Few indications concerned extubation failure, as early extubation was never attempted while the patient was dependent on oxygen support. Thirdly, intensivists' habits concerning tracheostomy for withdrawal of ventilation in respiratory distress of whatever etiology vary between centers, as seen in the present varied tracheostomy rates. Blot et al. [11] , in a retrospective study in 152 French intensive care units, were performed by ORL surgeons (Figure 1 ). In the other 2 centers, the figure could not be determined, due to the exponential increase in the number of intensive care beds at the height of the epidemic. The 37% rate of non-ORL tracheostomies is explained by the autonomy of intensivists, used to performing their own tracheostomies, percutaneously in 75% of cases, as reported in the international study by Vargas et al. [12] . The proportion performed by ORL surgeons varied from 0 to 100% between centers (Figure 1 ), certain intensivists calling systematically on ORL colleagues so as to alleviate their own workload, while others did so only in case of foreseeable problems contraindicating percutaneous tracheostomy.

In the present series, tracheostomy was performed at a mean 17±7 days after orotracheal intubation, in line with the 2018 multicenter study in 50 countries by Abe et al. [14, 15] .

Percutaneous tracheostomy is usually performed at the bedside in the intensive care unit, while surgical tracheostomy is performed in theater [13] . In centers A, C and D (fig 1) , respectively 45%, 80% and 100% of tracheostomies were performed in the intensive care unit, whatever the technique or patient characteristics, whereas in other centers tracheostomy was always performed surgically in the operating room. This corresponds to team habits, and was justified by fear of accidental extubation during transfer, with potential oxygen desaturation and virus aerosolization [15] . Limited theater access, with a reduced number of operative and recovery rooms, may also explain these differences between centers regarding the procedure site.

In intubation for non-Covid-19 acute respiratory distress, there is no clear consensus as to tracheostomy technique [13] . Percutaneous tracheostomy is quicker, by 13 minutes (95% If performed under fluoroscopic or ultrasound guidance, it can be used in first line in obese patients, as it entails fewer post-procedural complications than surgery in these cases: less bleeding, leakage, infection and pneumopathy [17] . In the present series, the rate of nonsevere postoperative complications was only 15%, and exclusively associated with surgical tracheostomy. In Covid-19-related respiratory distress, where there is a majority of obese patients, expert opinion as to technique differs [18] . The percutaneous technique can be performed by intensivists, and ensures good peri-cannula sealing for nursing care, but has the major drawback of increasing the risk of virus aerosolization during the procedure because of increasing the risk of operator contamination. In the present study, however, there were no cases of operator contamination despite the predominantly surgical technique. Percutaneous tracheostomy can also be made difficult by certain anatomic variants: short neck, history of cervicotomy, or obesity (which is frequent in Covid-19-related respiratory distress). Surgery has the advantages of being feasible whatever the anatomy, including obesity, with few intraoperative complications, and those few being mostly benign, and of being performed by the surgery team, thus alleviating the intensivist's workload. It also shows less risk of intraoperative aerosolization, as the balloon has been pushed down below the orifice.

However, the rate of postoperative complications is greater: bleeding, infection, defective sealing with risk of aerosolization. In the context of Covid-19, the SFORL, exceptionally, recommends the percutaneous technique, to reduce the risk of aerosolization during ventilation and post-tracheostomy cannula care [3] . The Canadian, Italian and British societies recommend surgery, and other societies make no recommendation [18] . In the present cohort, 91.5% of tracheostomies were surgical, although only 50.8% of patients were obese. This apparent contradiction with regard to French guidelines is due to the habits of head and neck surgeons, who are more used to surgery. The short operating time (27 minutes, far less than the mean 45 minutes reported in the literature [19] ) and low rates of intra-and post-operative complications argue for this attitude in experienced operators, as in the present series. The present study is in agreement with McGrath et al. [20] in an international working group recommending using the tracheostomy technique to which the operator is best accustomed, to intensivists. In the present cohort, percutaneous tracheostomy was associated with no immediate complications, although sample size was insufficient for comparison versus surgery. The almost systematic rate of surgery in the present series, in contradiction to the SFORL guidelines [3] but in line with those of other societies worldwide (no extra risk for either patient or operator) suggest that the SFORL guidelines [3] , drawn up urgently on the basis of the "precautionary principle", may need revising regarding the claimed superiority of percutaneous tracheostomy in the Covid-19 context.

There were few intra-(17%) or post-procedural (15%) complications in the present series, and no major complications or failures, with no significant differences according to technique (Table 2 ), in agreement with the literature [16] . One major risk of tracheostomy in the Covid-19 context is operator and care team contamination, as the procedure is highly liable to induce aerosolization [3] . Van Doremalen et al. [21] , modeling SARS-Co-V2 aerosolization by nebulization, found that the virus remained viable for 3 hours in aerosols.

Likewise , Feldman et al. [22] , simulating orotracheal intubation, fond aerosols on operators' hair and faces, despite personal protective equipment (PPE). Lastly, Chen et al. [23] , in a cohort of 758 care-staff assessed during the 2009 SARS epidemic, reported increased contamination risk in tracheostomy (6 persons infected: OR 4.15 (1.50~11.50); p<0.01); this p-value did not reach the 0.005 significance threshold advocated by various statisticians and the European Annals of Otorhinolaryngology Head & Neck Diseases [6, 7] , but even so the French Public Health Council (HCSP) (https://www.hcsp.fr/Explore.cgi/avisrapportsdomaine?clefr=830) and the SFORL [3] recommend FFP2 masks during invasive ORL procedures or maneuvers liable to lead to aerosolization of viral particles. There seems to be a consensus that optimal protection is mandatory in tracheostomy, recognized as an at-risk procedure, for surgeons and/or intensivists and/or anesthetists and all staff present during the procedure: at least an FFP2 or Page 13 of 26 J o u r n a l P r e -p r o o f 13 N95 mask, protective glasses with visor or protective suit, overcoat, cap, overshoes and double gloves [2, 18] . Thierry et al. developed a PPE mask by fitting an FFP2 filter onto a snorkeling mask to ensure sealing and air filtration [24] . Foster et al. described a canopy system with air aspiration associated to a filter below the surgical drapes to further reduce aerosolization risk [25] ; this was little used in the present cohort, being difficult to implement.

Collaboration with the anesthesia and intensive care teams is primordial to ensure sedation and complete neuromuscular block and total apnea when the trachea is opened [2, 3] . It is also important, if possible, to await SARS-Cov2-negative nasopharyngeal and/or tracheal samples to minimize contamination risk [18] . In the present series, tracheostomy was performed at a mean 20 days after diagnosis of Covid-19: i.e., with lowered or negative viral load in the upper and lower airway. The PPE set accounts for the absence of operator contamination, including in the 8 patients who were PCR-positive at the time of surgery. This raises the issue of the contagiousness of aerosolized viruses. Laccourreye et al. [26] , in a cohort of 224 consecutive patients undergoing surgery and/or endoscopy for head and neck cancer in 6 academic departments in the Paris area during the first month of lockdown, found no contamination of surgeons wearing simply an FFP2 mask, including in cases of tracheal opening in Covid-19-positive patients. Thus, a snorkeling mask plus protective suit [24, 27] may be an excess of caution, even in airway surgery.

Orotracheal intubation is liable to induce laryngotracheal lesions, proportionally to intubation time [28] . In a cohort of 775 patients with a median 8 days' intubation (range, 7.7-8.7 days) for non-Covid-19 respiratory distress, Brodsky et al. [29] found laryngeal lesions in 83% of cases; most were mild, with edema in 70% of cases, but with moderate or severe lesions in 31% and 13% of cases, respectively, notably including unilateral laryngeal immobility in 20% of severe cases. The British Association of Anaesthetists sounded the alarm concerning a high prevalence of post-intubation laryngeal edema in Covid-19 patients, J o u r n a l P r e -p r o o f 14 due not only to intubation as such but also perhaps to the action of the virus [30] . This could account for the present absence of significant association between patient characteristics, notably including age (known to be a risk factor for laryngotracheal sequelae [28] ), and laryngeal lesions (Table 4 ) or tracheostomy duration (Tables 3 and 5 ). Li et al. [31] demonstrated the central and peripheral neuroinvasive potential of SARS-Cov2, inducing critical illness neuromyopathy and laryngeal immobility. These data suggest an etiological role of SARS-CoV-2 in long-term laryngeal lesions, independently of intubation, which, however, also induces such lesions. Moreover, prone positioning with repeated turning, as frequently practiced on patients with Covid-19-related respiratory distress, can cause iterative laryngeal microtraumas when performed during intubation. These hypotheses agree with the present findings that, at 1 or 2 months post-extubation, laryngeal lesions were more frequent than usual following prolonged intubation: 55% of cases, with edema in 25% and unilateral laryngeal immobility in 15%; moreover, this prevalence was probably underestimated, as only 34% of patients underwent laryngotracheal assessment.

Despite its multicenter design, the present study had several biases. 1) Sample size was less than a hundred, as tracheostomy indications were fewer than expected and tracheostomies performed by intensivists were not included, leading to imbalance between surgical and percutaneous techniques, precluding statistical comparison. 2) In 2 of the 7 centers, while the number of tracheostomies performed by head and neck surgeons was known, the total numbers of intubations and of tracheostomies performed by both ORL surgeons and intensivists were not available, due to an exponential increase in the number of intensive care beds at the peak of the epidemic. 3) There was considerable loss to follow-up due to transfer to other departments or geographical regions for rehabilitation, without information to the ORL department or the operators.

Four main points emerged from this multicenter study in the Paris region of France to analyze the experience of tracheostomy performed by ORL surgeons in Covid-19 patients with prolonged intubation. 1) Unexpectedly few tracheostomies were in fact performed by ORL surgeons, and almost all were for ventilation withdrawal and were performed surgically, late in the care process. 2) Tracheostomy practices varied between centers, but with predominance of surgery, in contradiction to the SFORL recommendations, without major adverse effects whether in terms of severe complications in the patients or of contamination of the operators.

3) The rate of laryngotracheal sequelae was high, suggesting that tracheostomy might be performed earlier in future. 4) The rate of short-term loss to follow-up (within 2 months) was excessive, arguing for closer teamwork between intensivists and ORL surgeons and for specific ORL follow-up in a region-wide database for long-term assessment of sequalae and their treatment.

The authors have no conflicts of interest to disclose. 

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