Effects of Paratracheal Compression and Cricoid Compression on LMA ProSeal Placement

Not Applicable

Completed

• Conditions: Airway Management
• Interventions: Other: Cricoid pressure; Other: Paratracheal pressure

• Registration Number: NCT06616740
• Lead Sponsor: Karaman Training and Research Hospital

Brief Summary

The aim of this study is to compare the effect of paratracheal and cricoid pressure on LMA ProSeal insertion, insertion time, insertion difficulty, and the rate of optimal positioning of the device after insertion.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-23
• Study First Submitted QC: 2024-09-26
• Study First Posted: 2024-09-27
• Study Start: 2024-10-24
• Primary Completion: 2024-12-15
• Study Completion: 2024-12-16
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients aged 19-70 years who are scheduled for general anaesthesia for whom LMA management would be appropriate.

Exclusion Criteria

• with cervical spine disease
• expected difficult airway
• upper airway abnormalities
• body mass index (BMI) more than 35 kg/m2
• high risk of aspiration (hiatus hernia, gastro-oesophageal reflux disease and starvation)
• postoperative ventilator care
• surgeries requiring positions other than supine.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cricoid pressure group	Cricoid pressure	Cricoid pressure will be applied during LMA ProSeal insertion.
Paratracheal pressure group	Paratracheal pressure	Paratracheal pressure will be applied during LMA ProSeal insertion.

Primary Outcome Measures

Name	Time	Method
Duration of insertion	During intubation procedure	The time required for placement will be defined as the time from receipt of the LMA ProSeal to detection of the square waveform on capnography and will be calculated by summing the time taken for each attempt.

Secondary Outcome Measures

Name	Time	Method
Sensation of resistance during inserting of LMA ProSeal	During intubation procedure	Insertion of the LMA ProSeal will be assessed on a 4-point scale (1, no resistance; 2, moderate resistance; 3, severe resistance; and 4, impossible to insert the LMA ProSeal).
Anatomical location of the LMA ProSeal in the larynx and accuracy of insertion site.	1 minutes after intubation	It will be evaluated with a fibreoptic bronchoscope placed inside the tube section of the the LMA ProSeal. Accuracy will be recorded on a five-point scale (1, only the glottis is observed; 2, the posterior surface of the epiglottis and the glottis are observed; 3, the anterior part or tip of the epiglottis and \>50% of the glottis are observed; 4, the folded down epiglottis and \<50% of the glottis are observed; 5, the glottis is completely hidden by the folded down epiglottis)
Tidal volume and peak inspiratory pressure with or without each maneuver after LMA ProSeal insertion.	2 minutes after intubation	Tidal volume and peak inspiratory pressure with or without manoeuvre will be recorded with the same ventilator settings determined for all patients.
Oropharyngeal leak pressure	5 minutes after induction of general anesthesia	Oropharyngeal leak pressure will be assessed by closing the expiratory valve of the circle system to 40 cmH2o, with a fresh gas flow of 3 L/min and noting the airway pressure when equilibrium is reached or an audible air leak occurs.

Trial Locations

Locations (1)

Karaman Taining and Research Hospital; 🇹🇷 Karaman, Turkey