Tracheal Intubation in COVID-19 Patients

COVID-19 Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04909476
• Other study ID #: 125/20
• Status: Recruiting
• Start date: November 17, 2020
• Est. completion date: June 10, 2021

Study information

• Verified date: June 2021
• Source: St. Bortolo Hospital
• Contact: Silvia De Rosa, MD
• Phone: +393933098583
• Email: silvia.derosa[@]aulss8.veneto.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 143
• Est. completion date: June 10, 2021
• Est. primary completion date: May 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19 Pneumonia
• Pneumonia
• Tracheal Intubation

Intervention

Procedure:
• Endotracheal intubation
Airways management in COVID 19 patients pneumonia

Locations

Country	Name	City	State
Italy	San Matteo Hospital	Pavia	Lombardia
Italy	San Bortolo Hospital	Vicenza	Veneto

Sponsors (2)

Lead Sponsor	Collaborator
St. Bortolo Hospital	Fondazione IRCCS Policlinico San Matteo di Pavia

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View 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 COVID-19 Infection. Ann Acad Med Singap. 2020 Mar 16;49(3):108-118. — View Citation

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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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