Effects of Paratracheal Compression and Cricoid Compression on LMA ProSeal Placement

NCT ID: NCT06616740

Last Updated: 2025-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-24

Study Completion Date

2024-12-16

Brief Summary

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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

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Conditions

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Airway Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
patients, care providers, investigator and outcome assessors will be blinded.

Study Groups

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Cricoid pressure group

Cricoid pressure will be applied during LMA ProSeal insertion.

Group Type SHAM_COMPARATOR

Cricoid pressure

Intervention Type OTHER

Cricoid pressure will be applied during LMA ProSeal insertion.

Paratracheal pressure group

Paratracheal pressure will be applied during LMA ProSeal insertion.

Group Type EXPERIMENTAL

Paratracheal pressure

Intervention Type OTHER

Pratracheal pressure will be applied during LMA ProSeal insertion.

Interventions

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Cricoid pressure

Cricoid pressure will be applied during LMA ProSeal insertion.

Intervention Type OTHER

Paratracheal pressure

Pratracheal pressure will be applied during LMA ProSeal insertion.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karaman Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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muhammet korkusuz

Principal Investigator, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Muhammet Korkusuz, MD

Role: PRINCIPAL_INVESTIGATOR

Karamanoglu Mehmetbey University, School of Medicine

Locations

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Karaman Taining and Research Hospital

Karaman, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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04-2024/16

Identifier Type: -

Identifier Source: org_study_id

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