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Timing of Tracheotomy in Covid-19 Patients (TTCOV19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04412356
Recruitment Status : Recruiting
First Posted : June 2, 2020
Last Update Posted : June 9, 2020
Information provided by (Responsible Party):
Henrik Bergquist, Sahlgrenska University Hospital, Sweden

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) vs late (after at least 10 days) tracheotomy in covid-19 patients. The need for mechanical ventilation, sedation, additional oxygen support, frequency of complications, duration at the ICU and mortality will be evaluated and compared.

Condition or disease Intervention/treatment Phase
Covid-19 ARDS Tracheostomy Complication Respiratory Insufficiency Corona Virus Infection Procedure: Tracheotomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, single blinded, controlled trial
Masking: Single (Participant)
Masking Description: Patients will be blinded to the randomization outcome.
Primary Purpose: Treatment
Official Title: Timing of Tracheotomy in Covid-19 Positive Patients: a Randomized, Controlled Trial
Actual Study Start Date : June 4, 2020
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Early tracheotomy
Tracheotomy within 7 days after intubation.
Procedure: Tracheotomy
Surgical procedure to secure airway

Active Comparator: Late tracheotomy
Tracheotomy after at least 10 days after intubation.
Procedure: Tracheotomy
Surgical procedure to secure airway

Primary Outcome Measures :
  1. Mechanical ventilation [ Time Frame: 28 days ]
    Number of days without mechanical ventilation

Secondary Outcome Measures :
  1. ICU stay [ Time Frame: 28 days ]
    Number of days at ICU

  2. Oxygen support [ Time Frame: 28 days ]
    Number of days with need of additional oxygen support

  3. Sedation [ Time Frame: 28 days ]
    Number of days with the need of sedation

  4. Adverse events [ Time Frame: 28 days ]
    Various adverse events associated with the tracheotomy/tracheostomy

  5. Mortality [ Time Frame: 90 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04412356

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Contact: Henrik Bergquist, Assoc Prof +46 31 3421000
Contact: Måns Eeg-Olofsson, Assoc Prof +46 31 3421000

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Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden
Contact: Henrik Bergquist, Assoc Prof         
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
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Principal Investigator: Henrik Bergquist, Assoc Prof Sahlgrenska University Hospital, Sweden
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Responsible Party: Henrik Bergquist, MD, PhD, Associate Professor, Sahlgrenska University Hospital, Sweden Identifier: NCT04412356    
Other Study ID Numbers: HBergquist
First Posted: June 2, 2020    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Henrik Bergquist, Sahlgrenska University Hospital, Sweden:
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Virus Diseases
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections