Tracheal Intubation in COVID-19 Patients

Airways Management in COVID-19 Related Respiratory Failure: a Prospective Observational Multi-center Study

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).

Study Overview

• Status: Recruiting
• Conditions: COVID-19 Pneumonia; Tracheal Intubation
• Intervention / Treatment: Procedure: Endotracheal intubation

• Study Type: Observational
• Enrollment (Anticipated): 143

Contacts and Locations

• Study Contact: Name: Silvia De Rosa, MD; Phone Number: +393933098583; Email: silvia.derosa@aulss8.veneto.it

Study Locations

• Italy
  • Lombardia
    • Pavia, Lombardia, Italy, 27100
      • Recruiting
      • San Matteo Hospital
      • Contact: Silvia Mongodi, MD; Phone Number: +393491217156; Email: S.Mongodi@smatteo.pv.it
  • Veneto
    • Vicenza, Veneto, Italy, 36100
      • Recruiting
      • San Bortolo Hospital
      • Contact: Silvia De Rosa, MD; Phone Number: +39 3933098583; Email: silvia.derosa@aulss8.veneto.it
      • Principal Investigator: Silvia De Rosa, MD
      • Principal Investigator: Lucia Cattin, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Critically ill patient above 18 year old, admitted in the Intensive Care

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Severe COVID pneumonia with ET; Severe COVID 19 pneumonia undergoing endotracheal intubation	Procedure: Endotracheal intubation; Airways management in COVID 19 patients pneumonia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse peri-intubation events	The incidence of major adverse peri-intubation events defined as least one events: cardiovascular instability; severe Hypoxemia; cardiac arrest	intubation procedure, an expected average 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of minor complications in the intubation process in patients admitted in the intensive care	This study will analyze the prevalence of minor complications related to intubation technique in the the Critical Unit. This information will be useful in order to determinate the risk factors associated.	28 days
Correlation between videolaryngoscope use and incidence of complication compared to the conventional laryngoscopy	Although the video laryngoscope is useful to perform difficult airways management, the benefits associated to its employment is still controversial compared to the conventional laringoscope.	28 days

Collaborators and Investigators

• Sponsor: St. Bortolo Hospital
• Collaborators: Fondazione IRCCS Policlinico San Matteo di Pavia
• Investigators: Principal Investigator: Lucia Cattin, MD, SBortolo Hospital; Principal Investigator: Silvia De Rosa, MD, SBortolo Hospital; Principal Investigator: Silvia Mongodi, MD, SMatteo Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• Carrillo A, Gonzalez-Diaz G, Ferrer M, Martinez-Quintana ME, Lopez-Martinez A, Llamas N, Alcazar M, Torres A. Non-invasive ventilation in community-acquired pneumonia and severe acute respiratory failure. Intensive Care Med. 2012 Mar;38(3):458-66. doi: 10.1007/s00134-012-2475-6. Epub 2012 Feb 9.
• 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.
• Huang HB, Peng JM, Weng L, Liu GY, Du B. High-flow oxygen therapy in immunocompromised patients with acute respiratory failure: A review and meta-analysis. J Crit Care. 2018 Feb;43:300-305. doi: 10.1016/j.jcrc.2017.09.176. Epub 2017 Sep 22.
• 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). 2022 Aug 8:S2173-5727(22)00206-5. doi: 10.1016/j.medine.2022.08.005. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2020
• Primary Completion (Actual): May 20, 2021
• Study Completion (Anticipated): June 10, 2021

Study Registration Dates

• First Submitted: May 28, 2021
• First Submitted That Met QC Criteria: May 28, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Actual): June 4, 2021
• Last Update Submitted That Met QC Criteria: June 1, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 125/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No