Percutaneous Dilatation Tracheostomy, Broncoscopy, Pro-seal Laryngeal Mask

Eylem Yaşar

Status: Completed

Conditions: Tracheostomy Complication

Treatments: Procedure: Percutaneous Dilatation Tracheostomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04637932

2020/60

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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61 participants in 2 patient groups

Use of endotracheal tube During Percutaneous Dilatation Tracheostomy

Active Comparator group

Description:

Group 1 was determined as endotracheal tube

Treatment:

Procedure: Percutaneous Dilatation Tracheostomy

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

Active Comparator group

Description:

group 2 as pro-seal laryngeal mask group.

Treatment:

Procedure: Percutaneous Dilatation Tracheostomy