Safety Related Factors of Endotracheal Intubation in Pati... | NCT04298814

Studies
Safety Related Factors of Endotracheal Intubation in Patients With Severe Covid-19 Pneumonia

NCT04298814

Sponsor

Tongji Hospital

Status

Withdrawn

Last Update Posted

Jul 20, 2020Actual

Enrollment

0Actual

Phase

Not provided

Conditions

COVID-19
Endotracheal Intubation

Interventions

severe covid-19 pneumonia with ET

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

It was repeated with other studies in the same department

Expanded Access Info

Start Date

Aug 7, 2020Estimated

Primary Completion Date

Dec 30, 2020Estimated

Completion Date

Dec 30, 2020Estimated

First Submitted Date

Feb 26, 2020

First Submission Date that Met QC Criteria

Mar 4, 2020

First Posted Date

Mar 6, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 16, 2020

Last Update Posted Date

Jul 20, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

To analyze the intubation time, intubation condition, intubation process, intubation times and success rate of patients with severe covid-19 pneumonia, the infection rate of anesthesiologist after intubation, the degree of respiratory improvement and survival rate of patients, and summarizes the experience of how to avoid the infection of anesthesiologist and ensure the safety of patients with severe covid-19 pneumonia.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
severe covid-19 pneumonia with ET	Other	severe covid-19 pneumonia undergoing endotracheal intubation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Extubation time	Extubation time of intubated severe COVID-19 pneumonia patients	the time span between 1hour before intubation and 30days after intubation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Aijun XU, Dr.	Tongji Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tongji Hospital		Wuhan	Hubei	430000	China

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided