search
Back to results

Percutaneous Dilatation Tracheostomy, Broncoscopy, Pro-seal Laryngeal Mask

Primary Purpose

Tracheostomy Complication

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Percutaneous Dilatation Tracheostomy
Sponsored by
Eylem Yaşar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Tracheostomy Complication focused on measuring percutan tracheostomy, bronchoscopy, pro-seal Laryngeal mask

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mugla Sitki Kocman University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Use of endotracheal tube During Percutaneous Dilatation Tracheostomy

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

Arm Description

Group 1 was determined as endotracheal tube

group 2 as pro-seal laryngeal mask group.

Outcomes

Primary Outcome Measures

complication of percutan dilatation tracheostomy procedure.
blood gas analysis, physical examination, lung auscultation, hemodynamics parameters

Secondary Outcome Measures

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

Full Information

First Posted
November 3, 2020
Last Updated
December 13, 2021
Sponsor
Eylem Yaşar
search

1. Study Identification

Unique Protocol Identification Number
NCT04637932
Brief Title
Percutaneous Dilatation Tracheostomy, Broncoscopy, Pro-seal Laryngeal Mask
Official Title
Use of Pro-seal LMA and Bronchoscopy During Percutaneous Dilatation Tracheostomy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
November 20, 2020 (Actual)
Primary Completion Date
April 20, 2021 (Actual)
Study Completion Date
May 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eylem Yaşar

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tracheostomy Complication
Keywords
percutan tracheostomy, bronchoscopy, pro-seal Laryngeal mask

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Group 1 was determined as endotracheal tube and group 2 as pro-seal laryngeal mask group.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Use of endotracheal tube During Percutaneous Dilatation Tracheostomy
Arm Type
Active Comparator
Arm Description
Group 1 was determined as endotracheal tube
Arm Title
Use of Pro-seal LMA and Bronchoscopy During Percutaneous Dilatation Tracheostomy
Arm Type
Active Comparator
Arm Description
group 2 as pro-seal laryngeal mask group.
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Dilatation Tracheostomy
Other Intervention Name(s)
Bronchoscopy
Intervention Description
pro-seal laryngeal mask or intubation tube in bronchoscopy-guided percutaneous dilation tracheostomy procedure.
Primary Outcome Measure Information:
Title
complication of percutan dilatation tracheostomy procedure.
Description
blood gas analysis, physical examination, lung auscultation, hemodynamics parameters
Time Frame
7 days
Secondary Outcome Measure Information:
Title
processing time.
Description
Our secondary goal is to compare in terms of processing time.
Time Frame
minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
semra Demirbilek
Organizational Affiliation
Mugla Sitki Kocman University Department of AnesthesiaDepartment of Anesthesia
Official's Role
Study Director
Facility Information:
Facility Name
Mugla Sitki Kocman University
City
Mugla
ZIP/Postal Code
48000
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Percutaneous Dilatation Tracheostomy, Broncoscopy, Pro-seal Laryngeal Mask

We'll reach out to this number within 24 hrs