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Completed

NCT Number: NCT06616740

Effects of Paratracheal Compression and Cricoid Compression on LMA ProSeal Placement

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.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karaman Taining and Research Hospital

Karaman, 70200, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cricoid pressure

Other

Cricoid pressure will be applied during LMA ProSeal insertion.

Paratracheal pressure

Other

Pratracheal pressure will be applied during LMA ProSeal insertion.

Primary outcomes

  1. Duration of insertion

    Time frame: 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 outcomes

  1. Sensation of resistance during inserting of LMA ProSeal

    Time frame: 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).

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

    Time frame: 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)

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

    Time frame: 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.

  4. Oropharyngeal leak pressure

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Karaman Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 27, 2024
Registry last updated
Jan 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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