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OpenTrials
Completed

NCT Number: NCT04412356

Timing of Tracheotomy in Covid-19 Patients

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.

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Key information

Conditions

COVID-19 ARDS Corona Virus Infection Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Infections Tracheostomy Complication Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University Hospital

Gothenburg, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tracheotomy

Procedure

Surgical procedure to secure airway

Primary outcomes

  1. Mechanical ventilation

    Time frame: Through the individual ICU stay assessed up to 60 days

    Number of days with mechanical ventilation

Secondary outcomes

  1. ICU stay

    Time frame: Through the individual ICU stay assessed up to 60 days

    Number of days at ICU

  2. Oxygen support

    Time frame: Through the individual ICU stay assessed up to 60 days

    Number of days with need of additional oxygen support

  3. Sedation

    Time frame: Through the individual ICU stay assessed up to 60 days

    Number of days with the need of sedation

  4. Adverse events

    Time frame: Through the individual ICU stay assessed up to 60 days

    Various adverse events associated with the tracheotomy/tracheostomy

  5. Mortality

    Time frame: Through the individual ICU stay assessed up to 90 days

    Mortality

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Official study title

Timing of Tracheotomy in Covid-19 Positive Patients: a Randomized, Controlled Trial

Acronym: TTCOV19

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 2, 2020
Registry last updated
Sep 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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