Percutaneous Dilatation Tracheostomy, Broncoscopy, Pro-seal Laryngeal Mask

Study Overview
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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.

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

Conditions
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Tracheostomy Complication

Intervention / Treatment
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* Procedure: Percutaneous Dilatation Tracheostomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:hospitalized in intensive care units of our hospital and planned for elective percutaneous dilatation tracheostomy were included in the study. - Exclusion Criteria: history of cervical trauma, high-pressure mechanical ventilation (inspiratory pressure above 40 cmH2O), pulmonary edema, acute respiratory distress

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Group 1 was determined as endotracheal tube and group 2 as pro-seal laryngeal mask group.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Use of endotracheal tube During Percutaneous Dilatation Tracheostomy<br>Group 1 was determined as endotracheal tube | Procedure: Percutaneous Dilatation Tracheostomy<br>* pro-seal laryngeal mask or intubation tube in bronchoscopy-guided percutaneous dilation tracheostomy procedure.<br>* Other names: Bronchoscopy;|
| Active Comparator: Use of Pro-seal LMA and Bronchoscopy During Percutaneous Dilatation Tracheostomy<br>group 2 as pro-seal laryngeal mask group. | Procedure: Percutaneous Dilatation Tracheostomy<br>* pro-seal laryngeal mask or intubation tube in bronchoscopy-guided percutaneous dilation tracheostomy procedure.<br>* Other names: Bronchoscopy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complication of percutan dilatation tracheostomy procedure. | blood gas analysis, physical examination, lung auscultation, hemodynamics parameters | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| processing time. | Our secondary goal is to compare in terms of processing time. | minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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percutan tracheostomy, bronchoscopy, pro-seal Laryngeal mask