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

NCT05465837 | Completed

• 1 other identifier: MREC#2688
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Covid; COVID-19

Outcome Measures

Primary Outcomes (1)

• Mortality in Covid versus Non-Covid cases

  30 and 60 Days mortality

  upto 90 days

Secondary Outcomes (2)

• Ventilation days

  upto 90 days

• ICU length of stay

  upto 90 days

Study Arms (2)

Non covid Tracheostomy Patients

Adult patients (\>18 years) who underwent tracheostomy without having the covid-19 infection

Procedure: Tracheostomy

Covid-19 Tracheostomy Patients

Adult patients (\>18 years) who underwent tracheostomy had the covid-19 infection

Procedure: Tracheostomy

Interventions

Tracheostomy PROCEDURE

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

Covid-19 Tracheostomy Patients; Non covid Tracheostomy Patients

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• Tracheostomy performed as part of operative management.

Sponsors & Collaborators

• Sultan Qaboos University: lead

Study Sites (1)

Sultan Qaboos University Hospital

Muscat, 123, Oman

Location

Related Publications (7)

• 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.

  PMID: 32232423 BACKGROUND

• 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.

  PMID: 32296168 BACKGROUND

• 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.

  PMID: 17130697 BACKGROUND

• 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.

  PMID: 34955167 BACKGROUND

• 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.

  PMID: 23204058 BACKGROUND

• 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.

  PMID: 15693966 BACKGROUND

• 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.

  PMID: 25581416 RESULT

MeSH Terms

Conditions

COVID-19

Interventions

Tracheostomy

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Ostomy; Surgical Procedures, Operative; Otorhinolaryngologic Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Jyoti Burad

  Sultan Qaboos University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2022
• First Posted: July 20, 2022
• Study Start: February 25, 2022
• Primary Completion: June 28, 2022
• Study Completion: June 28, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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

Locations

OM (1)