Clinical trial NCT04909476: Tracheal Intubation in COVID-19 Patients
Official title: Airways Management in COVID-19 Related Respiratory Failure: a Prospective Observational Multi-center Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19 Pneumonia
Tracheal Intubation
Lead sponsor: St. Bortolo Hospital
Sponsor class: OTHER
Collaborators: name: Fondazione IRCCS Policlinico San Matteo di Pavia
First posted: 2021-06-01
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patient above 18 year old, admitted in the Intensive Care

Brief summary: The Emergency Endotracheal intubation of a patient who is COVID-19 positive is a high-risk procedure and an additional challenge to an intensivist due to barrier enclosures that have been developed to reduce the risk of COVID-19 transmission to healthcare providers during intubation. Although the incidence of difficult airways is commonly higher in critically ill patients, the evidence of severe hypoxemia without sign of respiratory distress could complicate the scenario.This silent hypoxia often leads to a delayed recognition of the severity of respiratory failure and to a late intubation which is often characterized by a high risk of complications related to the actual airways' management, hemodynamic and cardiac. It has been shown that non-survivors had worse blood gas analyzes than survivors, both before and after intubation. Few studies have reported the implications and adverse events of performing endotracheal intubation for critically ill COVID-19 patients admitted to intensive care units (ICUs).


Eligibility criteria: Inclusion Criteria:

* Critically ill patient above 18 year old, admitted in the Intensive Care of San Bortolo Hospital, Vicenza, and San Matteo Hospital, Pavia;
* positive specimen for SARS-COV2 PCR;
* tracheal intubation for respiratory distress related to SARS COV2 pneumonia

Exclusion Criteria:

* negative specimen for SARS-COV2 PCR
* out of hospital intubation
* intubation during cardiac arrest
* intubation in the contest of general anesthesia for surgery

Primary outcomes:
measure: Major adverse peri-intubation events
timeFrame: intubation procedure, an expected average 30 minutes
Secondary outcomes:
measure: Number of minor complications in the intubation process in patients admitted in the intensive care
timeFrame: 28 days
measure: Correlation between videolaryngoscope use and incidence of complication compared to the conventional laryngoscopy
timeFrame: 28 days
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: San Matteo Hospital
state: Lombardia
city: Vicenza
country: Italy
facility: San Bortolo Hospital
state: Veneto
Study officials:
affiliation: SBortolo Hospital
name: Lucia Cattin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: SBortolo Hospital
name: Silvia De Rosa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: SMatteo Hospital
name: Silvia Mongodi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yao W, Wang T, Jiang B, Gao F, Wang L, Zheng H, Xiao W, Yao S, Mei W, Chen X, Luo A, Sun L, Cook T, Behringer E, Huitink JM, Wong DT, Lane-Fall M, McNarry AF, McGuire B, Higgs A, Shah A, Patel A, Zuo M, Ma W, Xue Z, Zhang LM, Li W, Wang Y, Hagberg C, O'Sullivan EP, Fleisher LA, Wei H; collaborators. Emergency tracheal intubation in 202 patients with COVID-19 in Wuhan, China: lessons learnt and international expert recommendations. Br J Anaesth. 2020 Jul;125(1):e28-e37. doi: 10.1016/j.bja.2020.03.026. Epub 2020 Apr 10.
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citation: Goh KJ, Choong MC, Cheong EH, Kalimuddin S, Duu Wen S, Phua GC, Chan KS, Haja Mohideen S. Rapid Progression to Acute Respiratory Distress Syndrome: Review of Current Understanding of Critical Illness from Coronavirus Disease 2019 (COVID-19) Infection. Ann Acad Med Singap. 2020 Mar 16;49(3):108-118.
citation: Martin LD, Mhyre JM, Shanks AM, Tremper KK, Kheterpal S. 3,423 emergency tracheal intubations at a university hospital: airway outcomes and complications. Anesthesiology. 2011 Jan;114(1):42-8. doi: 10.1097/ALN.0b013e318201c415.
citation: Cattin L, Ferrari F, Mongodi S, Pariani E, Bettini G, Daverio F, Donadello K, Polati E, Mojoli F, Danzi V, De Rosa S. Airways management in SARS-COV-2 acute respiratory failure: A prospective observational multi-center study. Med Intensiva (Engl Ed). 2023 Mar;47(3):131-139. doi: 10.1016/j.medine.2022.08.005. Epub 2022 Aug 8.