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

NCT05465837 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 156

Last updated 2022-07-20

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Tracheostomy

Early and Late Tracheostomy (\</= 10 days: Early and \>10 days: Late)

Sponsors & Collaborators

  • Sultan Qaboos University

    lead OTHER

Principal Investigators

  • Jyoti Burad · Sultan Qaboos University Hospital

Eligibility

Min Age
18 Years
Max Age
88 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-25
Primary Completion
2022-06-28
Completion
2022-06-28

Countries

  • Oman

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05465837 on ClinicalTrials.gov