Endotracheal Tube Obstruction in Covid-19 Patients Requir... | NCT04394429

Studies
Endotracheal Tube Obstruction in Covid-19 Patients Requiring Mechanical Ventilation

NCT04394429

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Jan 8, 2021Actual

Enrollment

184Estimated

Phase

Not provided

Conditions

Sars-CoV2

Interventions

Not provided

Countries

France

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

May 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 24, 2020Actual

Primary Completion Date

Jun 24, 2021Estimated

Completion Date

Jun 24, 2021Estimated

First Submitted Date

May 18, 2020

First Submission Date that Met QC Criteria

May 18, 2020

First Posted Date

May 19, 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

Jan 7, 2021

Last Update Posted Date

Jan 8, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

The COVID-19 pandemic is very present in our region, the Grand-Est region is considered as one of the first COVID-19 epicentres in France. COVID-19 causes an acute respiratory distress syndrome requiring prolonged mechanical ventilation in resuscitation.

Detailed Description

Not provided

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

184Estimated

Measure	Description	Time Frame
Analysis of risk factors for intubation tube obstruction		1 month

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Major Subject (≥18 years)
Subject with COVID 19 (radiological suspicion or microbiological confirmation)
Subject hospitalised in the intensive care unit at the NHC of the University Hospitals of Strasbourg between 01/03/2020 and 03/04/2020.
Subject treated by mechanical ventilation
Subject who has not expressed his opposition, after information, to the re-use of his data for the purposes of this research

Translated with www.DeepL.com/Translator (free version)

Exclusion Criteria:

Subject who expressed opposition to participating in the study
Subject under guardianship, curatorship or safeguarding of justice

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subject with COVID 19 hospitalized in the intensive care unit at the NHC of the University Hospitals of Strasbourg

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bob HEGER, MD	Contact	33 3.69.55.04.43		Bob.Heger@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR	Contact	33 3 88 11 66 90		said.chayer@chru-strasbourg.fr

Overall Officials

Name	Affiliation	Role
Bob HEGER	Anesthesia-Resuscitation Department - Strasbourg University Hospitals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service d'Anesthésie-Réanimation - Nouvel Hôpital Civil	Recruiting	Strasbourg		67091	France

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