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

Government Medical College, Haldwani

Status: Completed

Conditions: Airway Morbidity

Treatments: Device: ProSeal Laryngeal mask airway; Device: Laryngeal Tube Suction- Disposable; Device: i-gel

Study type: Interventional

Funder types: Other

Identifiers

NCT02877940

203/GMC/IEC/04/2014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

150 participants in 3 patient groups

ProSeal Laryngeal mask airway

Active Comparator group

Description:

ProSeal will be inserted in mechanically ventilated patients undergoing elective surgeries.

Treatment:

Device: ProSeal Laryngeal mask airway

Laryngeal Tube Suction- Disposable

Active Comparator group

Description:

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

Treatment:

Device: Laryngeal Tube Suction- Disposable

Group I

Active Comparator group

Description:

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

Treatment:

Device: i-gel