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Completed

NCT Number: NCT02877940

Comparison of ProSeal Laryngeal Mask Airway, LTS-D and I-gel in Mechanically Ventilated Patients

The Aim of the study is to compare the clinical performance of p-LMA, i-gel and LTS-D in terms of the efficacy and safety in anaesthetized patient on Mechanical ventilation undergoing elective surgical procedure.

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Key information

Conditions

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The study aims to draw a comparison between ProSeal LMA, i-gel and LTS-D supraglottic airway devices in terms of the efficacy and safety in anaesthetised patient on Mechanical ventilation undergoing elective surgical procedure.

Methodology: A prospective randomized control study conducted on 150 patients undergoing elective surgical procedure under general anaesthesia at Dr Sushila Tiwari Hospital and Government medical college, Haldwani.

Following detailed pre-anaesthetic check-up, informed written consent was taken from patient fulfilling the required criteria. Patients were randomly allocated into 3 groups namely Group I (i-gel, n=50), Group P (p-LMA, n=50) and Group L (LTS-D, n=50) by online generated randomization.

Standard general anaesthesia protocol was followed and once adequate depth was achieved i-gel or p-LMA or LTS-D appropriate for weight or / and height was selected and inserted. An effective airway was confirmed and device was fixed from maxilla to maxilla.

The three groups were compared with respect to number of Insertion attempts, ease of insertion of device, time taken for placement of device, airway sealing pressure, ease and number of attempts of gastric tube placement and complications noted if any.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • American Society of Anaesthesiologists (ASA) class I/II.
  • Age 20-60years of either sex.
  • Weight between 40-60 kg of either sex.
  • Elective Surgical procedures of duration of 1-1½ hour with no need for endotracheal intubation.

Exclusion criteria

  • Patient with risk factors for difficult airway. (Mouth opening of <2cm, Mallampati class 4, limited neck extension, history of previous difficult intubation)
  • Any known pulmonary and cardiovascular diseases.
  • Risk of aspiration. (Full stomach, hiatus hernia, gastro-oesophageal reflex disease, emergency surgery)

Treatment and study plan

ProSeal Laryngeal mask airway

Device

ProSeal was inserted in mechanically ventilated patients undergoing elective surgeries.

Laryngeal Tube Suction- Disposable

Device

LTS-D was inserted in mechanically ventilated patients undergoing elective surgeries.

I-gel

Device

i-gel was inserted in mechanically ventilated patients undergoing elective surgeries.

Primary outcomes

  1. Number of Insertion attempts

    Time frame: 10 mins

Secondary outcomes

  1. Grading of insertion of device by Easy or Difficult

    Time frame: 10 min

    Easy insertion is defined as no resistance to insert in first attempt. Any repeat attempt or resistance to insertion is defined as Difficult.

  2. Time taken for placement of device

    Time frame: 10 min

  3. Airway sealing pressure

    Time frame: 10 min

  4. Number of attempts of gastric tube placement

    Time frame: 20 min

  5. Complication

    Time frame: 120 min

Sponsors and collaborators

Lead sponsor

Government Medical College, Haldwani

Other

Registry information

Official study title

A Randomized Controlled Trial Comparing Proseal Laryngeal Mask Airway, I-gel Airway and Laryngeal Tube Suction-D in Mechanically Ventilated Patients

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 24, 2016
Registry last updated
Aug 24, 2016

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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