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Completed

NCT Number: NCT05520957

Early SARS-CoV-2 Tracheostomy

Objective of this case series was to evaluate the characteristics of early COVID-19 tracheostomy and its effect on laboratory parameters. A series of 17 patients with COVID-19undergo surgical tracheostomy in our intensive care unit. Demographic parameters, duration indicators, and laboratory parameters before and after tracheostomy were analyzed in patients. Of the 17 patients, 4 were men and 13 women with a mean age of 59 years. The average length of total hospitalization were 12 days, the length of stay in intensive care were 10 days, the length of endotracheal intubation were 9 days, with the seventh day of tracheotomy. Neurological and thyroid diseases and withdrawal had a statistically significant difference (p <0.05), with laboratory parameters without statistically difference. Critically ill COVID-19 patients undergoing early tracheostomy has a lower possibility of weaning from mechanical ventilation, and early tracheostomy itself has no significant effect on renal parameters, lactate and D-Dimer.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cantonal Hospital

Zenica, 72000, Bosnia and Herzegovina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • COVID-19 postive patients
  • surgery tracheostomy patients

Exclusion criteria

  • trachestomy before admission in the ICU

Treatment and study plan

Tracheostomy

Procedure

We collected data from all tracheotomised patients including age, sex, existing comorbidities, duration indicators (length of endotracheal intubation, day of tracheotomy, length of stay in the intensive care unit (ICU), and total length of hospital stay), respirator weaning marked with YES / NO. From the laboratory parameters, we analyzed: lactate, urea, creatinine, potassium and D-dimer. They were collected at two time intervals, before tracheotomy and after tracheotomy.

Primary outcomes

  1. Characteristics of tracheotomized COVID-19 patients

    Time frame: 2 years

    We analysed age, sex, existing comorbidities, duration indicators (length of endotracheal intubation, day of tracheotomy, length of stay in the intensive care unit (ICU), and total length of hospital stay), respirator weaning marked with YES / NO. From the laboratory parameters, we analyzed: lactate, urea, creatinine, potassium and D-dimer. They were collected at two time intervals, before tracheotomy and after tracheotomy.

Sponsors and collaborators

Lead sponsor

Cantonal Hospital Zenica

Other

Registry information

Official study title

Early Tracheostomy in COVID-19 Critically Ill Patients: A Retrospective Case Series

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 30, 2022
Registry last updated
Sep 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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