Trial record 2 of 223483 for:    ALL

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr Subhro Mitra, Government Medical College, Haldwani
ClinicalTrials.gov Identifier:
NCT02877940
First received: August 17, 2016
Last updated: August 20, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention
Airway Morbidity
Device: ProSeal Laryngeal mask airway
Device: Laryngeal Tube Suction- Disposable
Device: i-gel

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing Proseal Laryngeal Mask Airway, I-gel Airway and Laryngeal Tube Suction-D in Mechanically Ventilated Patients

Further study details as provided by Government Medical College, Haldwani:

Primary Outcome Measures:
  • Number of Insertion attempts [ Time Frame: 10 mins ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Grading of insertion of device by Easy or Difficult [ Time Frame: 10 min ] [ Designated as safety issue: No ]
    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 [ Time Frame: 10 min ] [ Designated as safety issue: No ]
  • Airway sealing pressure [ Time Frame: 10 min ] [ Designated as safety issue: No ]
  • Number of attempts of gastric tube placement [ Time Frame: 20 min ] [ Designated as safety issue: No ]
  • Complication [ Time Frame: 120 min ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: December 2014
Study Completion Date: August 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ProSeal Laryngeal mask airway
ProSeal will be inserted in mechanically ventilated patients undergoing elective surgeries.
Device: ProSeal Laryngeal mask airway
ProSeal was inserted in mechanically ventilated patients undergoing elective surgeries.
Active Comparator: Laryngeal Tube Suction- Disposable
LTS-D will be inserted in mechanically ventilated patients undergoing elective surgeries.
Device: Laryngeal Tube Suction- Disposable
LTS-D was inserted in mechanically ventilated patients undergoing elective surgeries.
Active Comparator: Group I
i-gel will be inserted in mechanically ventilated patients undergoing elective surgeries..
Device: i-gel
i-gel was inserted in mechanically ventilated patients undergoing elective surgeries.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02877940

Sponsors and Collaborators
Government Medical College, Haldwani
Investigators
Principal Investigator: Geeta Bhandari, MD Professor
  More Information

Responsible Party: Dr Subhro Mitra, Assistant Professor, Government Medical College, Haldwani
ClinicalTrials.gov Identifier: NCT02877940     History of Changes
Other Study ID Numbers: 203/GMC/IEC/04/2014 
Study First Received: August 17, 2016
Last Updated: August 20, 2016
Health Authority: India: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Government Medical College, Haldwani:
ProSeal LMA
LTS-D
i-gel

ClinicalTrials.gov processed this record on August 23, 2016