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Percutaneous Dilatation Tracheostomy, Broncoscopy, Pro-seal Laryngeal Mask

NCT ID: NCT04637932

Last Updated: 2021-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-20

Study Completion Date

2021-05-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Tracheostomy Complication

Keywords

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percutan tracheostomy bronchoscopy pro-seal Laryngeal mask

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Group 1 was determined as endotracheal tube and group 2 as pro-seal laryngeal mask group.
Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Use of endotracheal tube During Percutaneous Dilatation Tracheostomy

Group 1 was determined as endotracheal tube

Group Type ACTIVE_COMPARATOR

Percutaneous Dilatation Tracheostomy

Intervention Type PROCEDURE

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

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

group 2 as pro-seal laryngeal mask group.

Group Type ACTIVE_COMPARATOR

Percutaneous Dilatation Tracheostomy

Intervention Type PROCEDURE

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

Interventions

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Percutaneous Dilatation Tracheostomy

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

Intervention Type PROCEDURE

Other Intervention Names

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Bronchoscopy

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

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

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eylem Yaşar

OTHER

Sponsor Role lead

Responsible Party

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Eylem Yaşar

Muğla Sıtkı Koçman Universty

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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semra Demirbilek

Role: STUDY_DIRECTOR

Mugla Sitki Kocman University Department of AnesthesiaDepartment of Anesthesia

Locations

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Mugla Sitki Kocman University

Muğla, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2020/60

Identifier Type: -

Identifier Source: org_study_id