Effects of Paratracheal Compression and Cricoid Compression on LMA ProSeal Placement

Karaman Training and Research Hospital80 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Airway Management

Interventions

Cricoid pressureOTHER

Cricoid pressure will be applied during LMA ProSeal insertion.

Paratracheal pressureOTHER

Pratracheal pressure will be applied during LMA ProSeal insertion.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Karaman Taining and Research Hospital

Karaman, Turkey (Türkiye)

Outcomes

Primary Outcomes

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.

Time frame: During intubation procedure

Secondary Outcomes

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).

Time frame: 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)

Time frame: 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.

Time frame: 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.

Time frame: 5 minutes after induction of general anesthesia

Data from ClinicalTrials.gov

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