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Tracheal Intubation in COVID-19 Patients

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04909476
Enrollment
143
Registered
2021-06-01
Start date
2020-11-17
Completion date
2021-06-10
Last updated
2021-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 Pneumonia, Tracheal Intubation

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).

Interventions

PROCEDUREEndotracheal intubation

Airways management in COVID 19 patients pneumonia

Sponsors

Fondazione IRCCS Policlinico San Matteo di Pavia
CollaboratorOTHER
St. Bortolo Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Major adverse peri-intubation eventsintubation procedure, an expected average 30 minutesThe incidence of major adverse peri-intubation events defined as least one events: * cardiovascular instability * severe Hypoxemia * cardiac arrest

Secondary

MeasureTime frameDescription
Number of minor complications in the intubation process in patients admitted in the intensive care28 daysThis 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.
Correlation between videolaryngoscope use and incidence of complication compared to the conventional laryngoscopy28 daysAlthough the video laryngoscope is useful to perform difficult airways management, the benefits associated to its employment is still controversial compared to the conventional laringoscope.

Countries

Italy

Contacts

Primary ContactSilvia De Rosa, MD
silvia.derosa@aulss8.veneto.it+393933098583

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026