NCT04412356

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started Jun 2020

Typical duration for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 2, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

June 6, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2021

Completed
Last Updated

September 22, 2021

Status Verified

September 1, 2021

Enrollment Period

12 months

First QC Date

May 24, 2020

Last Update Submit

September 20, 2021

Conditions

Covid-19ARDSTracheostomy ComplicationRespiratory InsufficiencyCorona Virus Infection

Keywords

Covid-19TracheotomyTracheostomyRCTARDS

Outcome Measures

Primary Outcomes (1)

  • Mechanical ventilation

    Number of days with mechanical ventilation

    Through the individual ICU stay assessed up to 60 days

Secondary Outcomes (5)

  • ICU stay

    Through the individual ICU stay assessed up to 60 days

  • Oxygen support

    Through the individual ICU stay assessed up to 60 days

  • Sedation

    Through the individual ICU stay assessed up to 60 days

  • Adverse events

    Through the individual ICU stay assessed up to 60 days

  • Mortality

    Through the individual ICU stay assessed up to 90 days

Study Arms (2)

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

TracheotomyPROCEDURE

Surgical procedure to secure airway

Early tracheotomyLate tracheotomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 35585614DERIVED

MeSH Terms

Conditions

COVID-19Respiratory InsufficiencyCoronavirus Infections

Interventions

Tracheotomy

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Officials

  • Henrik Bergquist, Assoc Prof

    Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patients will be blinded to the randomization outcome.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, single blinded, controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Associate Professor

Study Record Dates

First Submitted

May 24, 2020

First Posted

June 2, 2020

Study Start

June 6, 2020

Primary Completion

June 1, 2021

Study Completion

September 20, 2021

Last Updated

September 22, 2021

Record last verified: 2021-09

Locations

SE(1)