Effects of Paratracheal Compression and Cricoid Compression on LMA ProSeal Placement

NCT06616740 | Completed

• 1 other identifier: 04-2024/16
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Airway Management

Keywords

Airway management; LMA; Cricoid pressure; Paratracheal pressure; Supraglottic airway device

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Sensation of resistance during inserting of LMA ProSeal

  During intubation procedure

• Anatomical location of the LMA ProSeal in the larynx and accuracy of insertion site.

  1 minutes after intubation

• Tidal volume and peak inspiratory pressure with or without each maneuver after LMA ProSeal insertion.

  2 minutes after intubation

• Oropharyngeal leak pressure

  5 minutes after induction of general anesthesia

Study Arms (2)

Cricoid pressure group

SHAM COMPARATOR

Cricoid pressure will be applied during LMA ProSeal insertion.

Other: Cricoid pressure

Paratracheal pressure group

EXPERIMENTAL

Paratracheal pressure will be applied during LMA ProSeal insertion.

Other: Paratracheal pressure

Interventions

Cricoid pressure OTHER

Cricoid pressure will be applied during LMA ProSeal insertion.

Cricoid pressure group

Paratracheal pressure OTHER

Pratracheal pressure will be applied during LMA ProSeal insertion.

Paratracheal pressure group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karaman Training and Research Hospital: lead

Study Sites (1)

Karaman Taining and Research Hospital

Karaman, 70200, Turkey (Türkiye)

Location

Study Officials

• Muhammet Korkusuz, MD

  Karamanoglu Mehmetbey University, School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: patients, care providers, investigator and outcome assessors will be blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD

Model Details: There are two groups; 1. Experimental Group: Group P; paratracheal compression will be applied during LMA ProSeal insertion. 2. Sham Comparator: Group C; cricoid compression will be applied during LMA ProSeal insertion.

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 27, 2024
• Study Start: October 24, 2024
• Primary Completion: December 15, 2024
• Study Completion: December 16, 2024
• Last Updated: January 3, 2025

Record last verified: 2025-01

Locations

TU (1)