Timing of Tracheotomy in Covid-19 Patients | NCT04412356

Studies
Timing of Tracheotomy in Covid-19 Patients

NCT04412356

Sponsor

Sahlgrenska University Hospital

Status

Completed

Last Update Posted

Sep 22, 2021Actual

Enrollment

150Actual

Phase

Not Applicable

Conditions

Covid-19
ARDS
Tracheostomy Complication
Respiratory Insufficiency
Corona Virus Infection

Interventions

Tracheotomy

Countries

Sweden

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

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 6, 2020Actual

Primary Completion Date

Jun 1, 2021Actual

Completion Date

Sep 20, 2021Actual

First Submitted Date

May 24, 2020

First Submission Date that Met QC Criteria

May 31, 2020

First Posted Date

Jun 2, 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

Sep 20, 2021

Last Update Posted Date

Sep 22, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Henrik Bergquist, MD, PhD, Associate Professor, Sahlgrenska University HospitalPrincipal Investigator

Lead Sponsor

Sahlgrenska University HospitalOTHER

Collaborators

Not provided

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

Critically ill covid-19 patients may require respiratory support including mechanical ventilation. After an initial period with an endotracheal tube, a tracheotomy is performed in order to reduce potential airway complications, reduce the need of sedation and facilitate the monitoring and recovery. The optimal timing of this surgical procedure is, however, still unknown. The aim of this randomized, controlled trial is to compare the outcome of early (within 7 days after intubation) vs late (at least 10 days after intubation) tracheotomy in covid-19 patients. The need for mechanical ventilation, sedation, additional oxygen support, frequency of complications, duration at the ICU and mortality through the ICU stay will be evaluated and compared.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Early tracheotomy	Experimental	Tracheotomy within 7 days after intubation.	Procedure: Tracheotomy
Late tracheotomy	Active Comparator	Tracheotomy after at least 10 days after intubation.	Procedure: Tracheotomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tracheotomy	Procedure	Surgical procedure to secure airway	Early tracheotomy Late tracheotomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mechanical ventilation	Number of days with mechanical ventilation	Through the individual ICU stay assessed up to 60 days

Secondary Outcomes

Measure	Description	Time Frame
ICU stay	Number of days at ICU	Through the individual ICU stay assessed up to 60 days
Oxygen support	Number of days with need of additional oxygen support

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Verified Covid-19 infection
Intubated due to respiratory insufficiency and need for mechanical ventilation
Informed consent from patient or relative

Exclusion Criteria:

Age below 18 years
Need for mechanical ventilation less than 14 days
Tracheotomy not possible within 7 days
Tracheotomy not possible due to anatomical or other medical reasons

Accepts Healthy Volunteers

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Henrik Bergquist, Assoc Prof	Sahlgrenska University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sahlgrenska University Hospital		Gothenburg			Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35585614	Derived	Eeg-Olofsson M, Pauli N, Hafsten L, Jacobsson J, Lundborg C, Brink M, Larsson H, Lindell E, Lowhagen K, Gisslen M, Bergquist H. TTCOV19: timing of tracheotomy in SARS-CoV-2-infected patients: a multicentre, single-blinded, randomized, controlled trial. Crit Care. 2022 May 18;26(1):142. doi: 10.1186/s13054-022-04005-0.

ID	Term
D000086382	COVID-19
D012131	Respiratory Insufficiency
D018352	Coronavirus Infections

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

ID	Term
D013517	Otorhinolaryngologic Surgical Procedures
D013514	Surgical Procedures, Operative
D019616	Thoracic Surgical Procedures