Clinical trial NCT05465837: Comparison Between Early and Late Tracheostomy in Non-Covid and Covid
Official title: Comparison Between Early and Late Tracheostomy in ICU Patients Including Non-Covid and Covid Patients, an Observational Cohort Study at SQUH
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Covid
COVID-19
Lead sponsor: Sultan Qaboos University
Sponsor class: OTHER
First posted: 2022-07-20
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

Detailed description: Introduction:- Tracheostomy is a common procedure for critically ill patients who require long-term mechanical ventilation (3) and have a low Glasgow coma scale and for chest toileting. Compared with an endotracheal tube, a shorter tracheostomy tube that bypasses the mouth and pharynx can avoid oropharyngeal and laryngeal complications, improve patient comfort and reduce sedative drug use.

Early versus late tracheostomy:

In one study comparing early and late tracheostomy, they included eight RCTs. Results showed moderate quality from seven RCTs and lower mortality rates in the early as compared with the late tracheostomy group. On the other hand, in another study which was a prospective observational study, the results showed that there was no difference in 3-month mortality between early and late tracheostomy.

Covid-19 is a recently emerged disease and has resulted in an increasing number of patients requiring mechanical ventilation and ICU admission. Several recommendations and guidelines have discussed when to perform a tracheostomy in COVID-19 patients, while the timing is varied across the literature. Recommendations from the UK and North America suggested that tracheostomy should be delayed until at least 14 days from endotracheal intubation to clarify prognostic information and for the viral load to sufficiently decline. On the other hand, early tracheostomy may help in early weaning (around 7-10 days))

In this study, we aimed to investigate the differences in outcomes when tracheostomy is done early versus late in covid and non-covid cases.

Aim of the Study:

The aim of the current study is to analyze the outcomes of patients with confirmed SARS-CoV-2 pneumonia who underwent tracheostomies and explore the association between the timing of tracheostomy and the outcomes of these patients and compare them with Non-Covid-19 patients.

. The primary outcomes: Mortality in Covid versus Non-Covid cases The secondary outcomes: Ventilation days and ICU length of stay in Covid versus Non-Covid cases.

Methodology:- This retrospective study will be conducted in Sultan Qaboos University Hospital, Oman. After taking Ethics approval, all patients who undergo tracheostomy in intensive care units (ICUs) at SQUH from January 1, 2020, to December 2021 will be screened. A list of all patients who underwent tracheostomies during the study period will be obtained from the Hospital Information system. Their electronic patient records will be scanned, and data will be obtained.

Study Population:

Inclusions:

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

Exclusions:

• Tracheostomy performed as part of operative management.

Study Design and Methods:

Overview: This retrospective, observational cohort study will assess the outcomes of early and late tracheostomy in Non-Covid and Covid patients.

Sample size: All tracheostomized patients during the study period will be included in the study.

Study Method:

Medical records of patients will be reviewed, and data will be collected by investigators. Sociodemographic and clinical data will be collected for all patients, including age, sex, medical history, technique and day of ventilation days, ICU length of stay, and mortality.

Details of the tracheostomy procedure, including timing, type (percutaneous or surgical), and complications, will be noted.

Justification of the current study:

In this study, we intend to analyze the outcomes of early and late tracheostomy in covid and non-covid patients. We hope to find a strategy for choosing an appropriate time for tracheostomy in covid and non-covid patients, which will give better outcomes and help reduce ICU mortality, ventilator days, and length of stay.

ETHICAL Aspects:

The master chart will not carry patient names and even MRN will not be accessible to anyone except the principal investigator. In the end, the study subjects will be given code numbers in the final master chart and their ID will not be revealed to the statistician.

Data Management and Analyses:

Statistical analysis: Normally distributed and non-normally distributed continuous variables will be presented as the mean (SD) and median \[IQR\], respectively. Categorical variables are presented as numbers (%). Early tracheostomy will be defined as tracheostomy within 10 days of intubation, and late tracheostomy will be defined as tracheostomy after 10 days. All statistical analyses will be performed using the SPSS software system.

Eligibility 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.

Primary outcomes:
measure: Mortality in Covid versus Non-Covid cases
timeFrame: upto 90 days
Secondary outcomes:
measure: Ventilation days
timeFrame: upto 90 days
measure: ICU length of stay
timeFrame: upto 90 days
Other outcomes:
Locations:
city: Muscat
country: Oman
facility: Sultan Qaboos University Hospital
Study officials:
affiliation: Sultan Qaboos University Hospital
name: Jyoti Burad
role: PRINCIPAL_INVESTIGATOR
References:
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