Percutaneous Dilatation Tracheostomy, Broncoscopy, Pro-seal Laryngeal Mask

Tracheostomy Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04637932
• Other study ID #: 2020/60
• Status: Completed
• Phase: N/A
• Start date: November 20, 2020
• Est. completion date: May 20, 2021

Study information

• Verified date: December 2021
• Source: Mugla Sitki Koçman University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: May 20, 2021
• Est. primary completion date: April 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Tracheostomy Complication

Intervention

Procedure:
• Percutaneous Dilatation Tracheostomy
pro-seal laryngeal mask or intubation tube in bronchoscopy-guided percutaneous dilation tracheostomy procedure.

Locations

Country	Name	City	State
Turkey	Mugla Sitki Kocman University	Mugla

Sponsors (1)

Lead Sponsor	Collaborator
Eylem Yasar

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complication of percutan dilatation tracheostomy procedure.	blood gas analysis, physical examination, lung auscultation, hemodynamics parameters	7 days
Secondary	processing time.	Our secondary goal is to compare in terms of processing time.	minutes