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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02877940

Enrollment

150

Registered

2016-08-24

Start date

2014-12-31

Completion date

2016-08-31

Last updated

2016-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Morbidity

Keywords

ProSeal LMA, LTS-D, i-gel

Brief summary

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.

Detailed description

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.

Interventions

DEVICEProSeal Laryngeal mask airway

ProSeal was inserted in mechanically ventilated patients undergoing elective surgeries.

DEVICELaryngeal Tube Suction- Disposable

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

DEVICEi-gel

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to 60 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
Number of Insertion attempts	10 mins

Secondary

Measure	Time frame	Description
Grading of insertion of device by Easy or Difficult	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.
Time taken for placement of device	10 min	—
Airway sealing pressure	10 min	—
Number of attempts of gastric tube placement	20 min	—
Complication	120 min	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026