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Comparison Between Early and Late Tracheostomy in Non-Covid and Covid (CELT)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05465837
Recruitment Status : Completed
First Posted : July 20, 2022
Last Update Posted : July 20, 2022
Sponsor:
Information provided by (Responsible Party):
Sultan Qaboos University

Brief Summary:

Tracheostomy is commonly indicated for the patient who is requiring long period of mechanical ventilation. Patient who require mechanical ventilation for >10 days and longer mostly get tracheostomized. Tracheostomy is associated with less complications associated with endotracheal intubation. Tracheostomy is a surgical procedure whereby an external artificial opening is made in the trachea. Several techniques are used to perform tracheostomy, including the classical standard surgical procedure completed in a surgical room and the percutaneous method performed at the patient's bedside. Surgical and percutaneous procedures are usually performed by different surgical specialists such as general; thoracic; ear, nose and throat (ENT); or maxillofacial surgeons, but percutaneous procedures are usually but not exclusively performed by surgeons and intensivists.

Early tracheostomy might reduce the length of ICU stay, whereas delaying the tracheostomy might avoid a few. A review of recent studies showed a decrease in the mortality rate in early tracheostomised patients compared with late. Tracheostomy is a routine bedside procedure in ICU with minimal complications.

Severe acute respiratory syndrome (SARS) and Coronavirus 2 (SARS-CoV-2) started to appear in Oman in early February 2020, resulting in an escalation of new cases within days. In the first weeks of the pandemic, many guidelines from different specialties recommended avoiding early tracheostomy to minimize the risk of infection to clinicians.

Specifically, recommendations for tracheostomy in the current pandemic were rooted in the assumption that maximal infectivity of this novel virus occurred around day 7 to 10 after symptom onset, and performing tracheostomy at that time would endanger maximal risk to those performing it. Hence these factors interfered with the timing of Tracheostomy for Covid patients.

This is an observational cohort study. It will assess patients admitted to ICU at SQUH during the period between January 2020 and December 2021 with Non-Covid and Covid-19 patients. This study will assess the causes and outcomes of early and late tracheostomy in Non-Covid and Covid-19 patients requiring mechanical ventilation. Main outcomes will include mortality rate, ventilation days, and ICU length of stay.


Condition or disease Intervention/treatment
Non-Covid COVID-19 Procedure: Tracheostomy

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Study Type : Observational
Actual Enrollment : 156 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Comparison Between Early and Late Tracheostomy in ICU Patients Including Non-Covid and Covid Patients, an Observational Cohort Study at SQUH
Actual Study Start Date : February 25, 2022
Actual Primary Completion Date : June 28, 2022
Actual Study Completion Date : June 28, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Non covid Tracheostomy Patients
Adult patients (>18 years) who underwent tracheostomy without having the covid-19 infection
Procedure: Tracheostomy
Early and Late Tracheostomy (</= 10 days: Early and >10 days: Late)

Covid-19 Tracheostomy Patients
Adult patients (>18 years) who underwent tracheostomy had the covid-19 infection
Procedure: Tracheostomy
Early and Late Tracheostomy (</= 10 days: Early and >10 days: Late)




Primary Outcome Measures :
  1. Mortality in Covid versus Non-Covid cases [ Time Frame: upto 90 days ]
    30 and 60 Days mortality


Secondary Outcome Measures :
  1. Ventilation days [ Time Frame: upto 90 days ]
    Number of ventilation days

  2. ICU length of stay [ Time Frame: upto 90 days ]
    ICU length of stay total



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Ages Eligible for Study:   18 Years to 88 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult Population > 18 years old, admitted to Non-Covid and Covid-19 ICU OF Sultan Qaboos University Hospital, Oman, who got tracheostomized during their stay in ICU
Criteria

Inclusion Criteria:

  • • Adult ICU patients (more than 18 years old) who underwent tracheostomy in ICU.

Exclusion Criteria:

  • • Tracheostomy performed as part of operative management.

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 ClinicalTrials.gov identifier (NCT number): NCT05465837


Locations
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Oman
Sultan Qaboos University Hospital
Muscat, Oman, 123
Sponsors and Collaborators
Sultan Qaboos University
Investigators
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Principal Investigator: Jyoti Burad Sultan Qaboos University Hospital
Publications of Results:
Other Publications:

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Responsible Party: Sultan Qaboos University
ClinicalTrials.gov Identifier: NCT05465837    
Other Study ID Numbers: MREC#2688
First Posted: July 20, 2022    Key Record Dates
Last Update Posted: July 20, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The IPD will be deposited to Repository: Mendeley and will be made available after this study is published
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code
Time Frame: The data will be made available after this study is published (after a few months of publication, up to 5 years)
Access Criteria: Will be provided to a researcher interested and writes to the Principal investigator about the need for the data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No