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Completed

NCT Number: NCT04637932

Percutaneous Dilatation Tracheostomy, Broncoscopy, Pro-seal Laryngeal Mask

In this study, our primary goal is to compare whether there is any difference in the complication of using pro-seal laryngeal mask or intubation tube in bronchoscopy-guided percutaneous dilation tracheostomy procedure. Our secondary goal is to compare in terms of processing time.

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Key information

Conditions

Tracheostomy Complication

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mugla Sitki Kocman University

Muğla, 48000, Turkey (Türkiye)

About this study

Following the approval of Muğla Sıtkı Koçman University Clinical Research Ethics Committee, 61 cases over the age of 18 who were scheduled for elective percutaneous dilatation tracheostomy in intensive care units were included in the study.

Elective percutaneous dilatation tracheostomy cases were randomly divided into two groups. Group 1 was determined as endotracheal tube and group 2 as pro-seal laryngeal mask group.

In the endotracheal tube group, which is a conventional method, after entering the trachea with percutaneous technique, the intubation tube was removed before dilatation and percutaneous dilatation tracheostomy was performed with the Seldinger method.

In the pro-seal laryngeal mask group, the fiberoptic bronchoscope was advanced with a pro-seal laryngeal mask, and after the correct position was achieved, percutaneous dilatation tracheostomy was performed using the Seldinger Method.

Arterial blood pressure, oxygen saturation, heart rate, arterial blood gas, mechanical ventilation mode, positive end expiratory pressure and mean airway pressure values were recorded before and 30 minutes after the procedure.

The time until the end of the procedure and complications were determined.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

hospitalized in intensive care units of our hospital and planned for elective percutaneous dilatation tracheostomy were included in the study.

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Exclusion criteria

  • history of cervical trauma,
  • high-pressure mechanical ventilation (inspiratory pressure above 40 cmH2O),
  • pulmonary edema,
  • acute respiratory distress

Treatment and study plan

Percutaneous Dilatation Tracheostomy

Procedure

pro-seal laryngeal mask or intubation tube in bronchoscopy-guided percutaneous dilation tracheostomy procedure.

Other names: Bronchoscopy

Primary outcomes

  1. complication of percutan dilatation tracheostomy procedure.

    Time frame: 7 days

    blood gas analysis, physical examination, lung auscultation, hemodynamics parameters

Secondary outcomes

  1. processing time.

    Time frame: minutes

    Our secondary goal is to compare in terms of processing time.

Sponsors and collaborators

Lead sponsor

Eylem Yaşar

Other

Registry information

Official study title

Use of Pro-seal LMA and Bronchoscopy During Percutaneous Dilatation Tracheostomy

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 20, 2020
Registry last updated
Dec 14, 2021

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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