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Status unknownNCT04909476Updated Jun 4, 2021

Tracheal Intubation in COVID-19 Patients

An observational study in COVID-19 Pneumonia and Tracheal Intubation, sponsored by St. Bortolo Hospital. Status unknown at 2 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-04.

Sponsored by St. Bortolo Hospital · Observational

The sponsor has not verified this record recently (last verified Jun 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
143
Ages
18 Years and older
Sex
All
01

Study 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).

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Conditions studied

  • COVID-19 Pneumonia
  • Tracheal Intubation
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In context

COVID-19

7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.

This study's planned enrollment of 143 is below the median of 268 across 3,208 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

St. Bortolo Hospital is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
143 participants (estimated)
Patient registry
No

Groups and cohorts

  • Severe COVID pneumonia with ET

    Severe COVID 19 pneumonia undergoing endotracheal intubation

    Procedure: Endotracheal intubation

Interventions

  • ProcedureEndotracheal intubation

    Airways management in COVID 19 patients pneumonia

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What researchers measure

Primary outcomes

  1. Major adverse peri-intubation events

    The incidence of major adverse peri-intubation events defined as least one events: * cardiovascular instability * severe Hypoxemia * cardiac arrest

    Time frame: intubation procedure, an expected average 30 minutes

Secondary outcomes

  1. 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.

    Time frame: 28 days

  2. 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.

    Time frame: 28 days

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Study locations

2 of 2 sites recruiting
  • San Matteo Hospital
    Pavia, Lombardia 27100, Italy
    Recruiting
  • San Bortolo Hospital
    Vicenza, Veneto 36100, Italy
    Recruiting
    • Silvia De Rosa, MD · Contactsilvia.derosa@aulss8.veneto.it · +39 3933098583
    • Silvia De Rosa, MD · Principal investigator
    • Lucia Cattin, MD · Principal investigator
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References and documents

Publications

  • 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. PubMed 32312571 ↗
  • 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. PubMed 22318634 ↗
  • 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. PubMed 28968525 ↗
  • 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. PubMed 32200400 ↗
  • 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. PubMed 21150574 ↗
  • 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. PubMed 36155747 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04909476
Lead sponsor
St. Bortolo Hospital
Responsible party
Silvia De Rosa (Principal Investigator, St. Bortolo Hospital) — Principal investigator
First posted
Jun 1, 2021
Start date
Nov 17, 2020
Primary completion
May 20, 2021
Completion
Jun 10, 2021 (estimated)
Last update
Jun 4, 2021

Study contacts

Silvia De Rosa, MD
Contact
silvia.derosa@aulss8.veneto.it
+393933098583
Lucia Cattin, MD
principal investigator · SBortolo Hospital
Silvia De Rosa, MD
principal investigator · SBortolo Hospital
Silvia Mongodi, MD
principal investigator · SMatteo Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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