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

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

Study Description

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

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.

Study Design

• 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

Groups and Cohorts

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)

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Locations

Oman

Sultan Qaboos University Hospital

Muscat, Oman, 123

Sponsors and Collaborators

Sultan Qaboos University

Investigators

• Principal Investigator: Jyoti Burad; Sultan Qaboos University Hospital

More Information

Publications of Results:

Andriolo BN, Andriolo RB, Saconato H, Atallah AN, Valente O. Early versus late tracheostomy for critically ill patients. Cochrane Database Syst Rev. 2015 Jan 12;1(1):CD007271. doi: 10.1002/14651858.CD007271.pub3.

Other Publications:

Givi B, Schiff BA, Chinn SB, Clayburgh D, Iyer NG, Jalisi S, Moore MG, Nathan CA, Orloff LA, O'Neill JP, Parker N, Zender C, Morris LGT, Davies L. Safety Recommendations for Evaluation and Surgery of the Head and Neck During the COVID-19 Pandemic. JAMA Otolaryngol Head Neck Surg. 2020 Jun 1;146(6):579-584. doi: 10.1001/jamaoto.2020.0780.

He X, Lau EHY, Wu P, Deng X, Wang J, Hao X, Lau YC, Wong JY, Guan Y, Tan X, Mo X, Chen Y, Liao B, Chen W, Hu F, Zhang Q, Zhong M, Wu Y, Zhao L, Zhang F, Cowling BJ, Li F, Leung GM. Temporal dynamics in viral shedding and transmissibility of COVID-19. Nat Med. 2020 May;26(5):672-675. doi: 10.1038/s41591-020-0869-5. Epub 2020 Apr 15. Erratum In: Nat Med. 2020 Sep;26(9):1491-1493.

Scales DC, Ferguson ND. Tracheostomy: it's time to move from art to science. Crit Care Med. 2006 Dec;34(12):3039-40. doi: 10.1097/01.CCM.0000242924.24342.9D. No abstract available.

Polok K, Fronczek J, van Heerden PV, Flaatten H, Guidet B, De Lange DW, Fjolner J, Leaver S, Beil M, Sviri S, Bruno RR, Wernly B, Artigas A, Pinto BB, Schefold JC, Studzinska D, Joannidis M, Oeyen S, Marsh B, Andersen FH, Moreno R, Cecconi M, Jung C, Szczeklik W; COVIP study group. Association between tracheostomy timing and outcomes for older critically ill COVID-19 patients: prospective observational study in European intensive care units. Br J Anaesth. 2022 Mar;128(3):482-490. doi: 10.1016/j.bja.2021.11.027. Epub 2021 Nov 29.

Bosel J, Schiller P, Hook Y, Andes M, Neumann JO, Poli S, Amiri H, Schonenberger S, Peng Z, Unterberg A, Hacke W, Steiner T. Stroke-related Early Tracheostomy versus Prolonged Orotracheal Intubation in Neurocritical Care Trial (SETPOINT): a randomized pilot trial. Stroke. 2013 Jan;44(1):21-8. doi: 10.1161/STROKEAHA.112.669895. Epub 2012 Nov 29.

Hsu CL, Chen KY, Chang CH, Jerng JS, Yu CJ, Yang PC. Timing of tracheostomy as a determinant of weaning success in critically ill patients: a retrospective study. Crit Care. 2005 Feb;9(1):R46-52. doi: 10.1186/cc3018. Epub 2004 Dec 23.

• Responsible Party: Sultan Qaboos University
• ClinicalTrials.gov Identifier: NCT05465837
• Other Study ID Numbers: MREC#2688
• First Posted: July 20, 2022
• 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

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