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Percutaneous Dilatation Tracheostomy, Broncoscopy, Pro-seal Laryngeal Mask

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04637932
Enrollment
61
Registered
2020-11-20
Start date
2020-11-20
Completion date
2021-05-20
Last updated
2021-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tracheostomy Complication

Keywords

percutan tracheostomy, bronchoscopy, pro-seal Laryngeal mask

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.

Interventions

PROCEDUREPercutaneous Dilatation Tracheostomy

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

Sponsors

Eylem Yaşar
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
complication of percutan dilatation tracheostomy procedure.7 daysblood gas analysis, physical examination, lung auscultation, hemodynamics parameters

Secondary

MeasureTime frameDescription
processing time.minutesOur secondary goal is to compare in terms of processing time.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026