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

Airway Morbidity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02877940
• Other study ID #: 203/GMC/IEC/04/2014
• Status: Completed
• Phase: N/A
• First received: August 17, 2016
• Last updated: August 20, 2016
• Start date: December 2014
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: Government Medical College, Haldwani
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Airway Morbidity

Intervention

Device:
• ProSeal Laryngeal mask airway
ProSeal was inserted in mechanically ventilated patients undergoing elective surgeries.
• Laryngeal Tube Suction- Disposable
LTS-D was inserted in mechanically ventilated patients undergoing elective surgeries.
• i-gel
i-gel was inserted in mechanically ventilated patients undergoing elective surgeries.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Government Medical College, Haldwani

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Insertion attempts		10 mins
Secondary	Grading of insertion of device by Easy or Difficult	Easy insertion is defined as no resistance to insert in first attempt. Any repeat attempt or resistance to insertion is defined as Difficult.	10 min
Secondary	Time taken for placement of device		10 min
Secondary	Airway sealing pressure		10 min
Secondary	Number of attempts of gastric tube placement		20 min
Secondary	Complication		120 min