Effects of Paratracheal Compression and Cricoid Compression on LMA ProSeal Placement

Comparison of the Effects of Paratracheal Compression and Cricoid Compression on LMA ProSeal Placement: a Randomised Clinical Trial.

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.

Study Overview

• Status: Completed
• Conditions: Airway Management
• Intervention / Treatment: Other: Cricoid pressure; Other: Paratracheal pressure

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Karaman, Turkey, 70200
    • Karaman Taining and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Cricoid pressure group; Cricoid pressure will be applied during LMA ProSeal insertion.	Other: Cricoid pressure; Cricoid pressure will be applied during LMA ProSeal insertion.
Experimental: Paratracheal pressure group; Paratracheal pressure will be applied during LMA ProSeal insertion.	Other: Paratracheal pressure; Pratracheal pressure will be applied during LMA ProSeal insertion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of insertion	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.	During intubation procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensation of resistance during inserting of LMA ProSeal	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).	During intubation procedure
Anatomical location of the LMA ProSeal in the larynx and accuracy of insertion site.	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)	1 minutes after intubation
Tidal volume and peak inspiratory pressure with or without each maneuver after LMA ProSeal insertion.	Tidal volume and peak inspiratory pressure with or without manoeuvre will be recorded with the same ventilator settings determined for all patients.	2 minutes after intubation
Oropharyngeal leak pressure	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.	5 minutes after induction of general anesthesia

Collaborators and Investigators

• Sponsor: Karaman Training and Research Hospital
• Investigators: Principal Investigator: Muhammet Korkusuz, MD, Karamanoglu Mehmetbey University, School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2024
• Primary Completion (Actual): December 15, 2024
• Study Completion (Actual): December 16, 2024

Study Registration Dates

• First Submitted: September 23, 2024
• First Submitted That Met QC Criteria: September 26, 2024
• First Posted (Actual): September 27, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 2, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Supraglottic airway device; Airway management; Cricoid pressure; LMA; Paratracheal pressure
• Other Study ID Numbers: 04-2024/16

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No