NCT04298814

Brief Summary

To analyze the intubation with severe covid-19 pneumonia, the infection rate of anesthesiologist after intubation, and summarizes the experience of how to avoid the infection of anesthesiologist and ensure the safety of patients with severe covid-19 pneumonia.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 6, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

August 7, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

July 20, 2020

Status Verified

July 1, 2020

Enrollment Period

5 months

First QC Date

February 26, 2020

Last Update Submit

July 16, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Success rate of intubation

    The data of Success rate of intubation with severe COVID-19 pneumonia patients

    the time span between 1hour before intubation and 24h after intubation

  • Infection rate of Anesthesiologist

    Infection rate of Anesthesiologist who performed the endotracheal intubation for severe COVID-19 pneumonia patients

    the time span between 1hour before intubation and 14days after intubation

Secondary Outcomes (1)

  • Extubation time

    the time span between 1hour before intubation and 30days after intubation

Interventions

severe covid-19 pneumonia undergoing endotracheal intubation

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Severe and critical patients with covid-19 pneumonia in urgent need of tracheal intubation

You may qualify if:

  • Wuhan residents;
  • novel coronavirus pneumonia was found to be characterized by fever and cough. Laboratory tests revealed leukocyte or lymphocyte decrease, chest CT examination showed viral pneumonia changes, and was diagnosed as COVID-19 pneumonia according to the national health and Health Committee's new coronavirus pneumonia diagnosis and treatment plan (trial version fifth Revision).
  • Severe and critical patients with covid-19 pneumonia in urgent need of tracheal intubation;
  • Sign informed consent.

You may not qualify if:

  • Suspected patients with covid-19 pneumonia;
  • Patients who need emergency endotracheal intubation due to other causes of respiratory failure;
  • The family refused to sign the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Aijun XU, Dr.

    Tongji Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

February 26, 2020

First Posted

March 6, 2020

Study Start

August 7, 2020

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

July 20, 2020

Record last verified: 2020-07

Locations