Percutaneous Dilatation Tracheostomy, Broncoscopy, Pro-seal Laryngeal Mask

NCT04637932 | Completed DMC

• 1 other identifier: 2020/60
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Tracheostomy Complication

Keywords

percutan tracheostomy; bronchoscopy; pro-seal Laryngeal mask

Outcome Measures

Primary Outcomes (1)

• complication of percutan dilatation tracheostomy procedure.

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

  7 days

Secondary Outcomes (1)

• processing time.

  minutes

Study Arms (2)

Use of endotracheal tube During Percutaneous Dilatation Tracheostomy

ACTIVE COMPARATOR

Group 1 was determined as endotracheal tube

Procedure: Percutaneous Dilatation Tracheostomy

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

ACTIVE COMPARATOR

group 2 as pro-seal laryngeal mask group.

Procedure: Percutaneous Dilatation Tracheostomy

Interventions

Percutaneous Dilatation Tracheostomy PROCEDURE

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

Also known as: Bronchoscopy

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• Eylem Yaşar: lead

Study Sites (1)

Mugla Sitki Kocman University

Muğla, 48000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Bronchoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• semra Demirbilek

  Mugla Sitki Kocman University Department of AnesthesiaDepartment of Anesthesia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Muğla Sıtkı Koçman Universty

Model Details: Group 1 was determined as endotracheal tube and group 2 as pro-seal laryngeal mask group.

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: November 20, 2020
• Study Start: November 20, 2020
• Primary Completion: April 20, 2021
• Study Completion: May 20, 2021
• Last Updated: December 14, 2021

Record last verified: 2021-12

Locations

TU (1)