Timing of Tracheotomy in Covid-19 Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-06

Study Completion Date

2021-09-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Optimal Timing for Tracheostomy in Invasively Mechanically Ventilated COVID-19 Patients

NCT06346210

COVID-19

COMPLETED

Percutaneous Tracheostomy With COVID-19

NCT04447638

Tracheostomy

COMPLETED

Comparison Between Early and Late Tracheostomy in Non-Covid and Covid

NCT05465837

Non-Covid COVID-19

COMPLETED

Airway Management During Unusual Tracheal Stenosis

NCT05317923

Tracheal Stenosis

COMPLETED NA

Tracheostomy Change

NCT04105387

Tracheostomy

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Covid-19 ARDS Tracheostomy Complication Respiratory Insufficiency Corona Virus Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, single blinded, controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Patients will be blinded to the randomization outcome.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Early tracheotomy

Tracheotomy within 7 days after intubation.

Group Type EXPERIMENTAL

Tracheotomy

Intervention Type PROCEDURE

Surgical procedure to secure airway

Late tracheotomy

Tracheotomy after at least 10 days after intubation.

Group Type ACTIVE_COMPARATOR

Tracheotomy

Intervention Type PROCEDURE

Surgical procedure to secure airway

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tracheotomy

Surgical procedure to secure airway

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No