Clinical trial NCT02877940: Comparison of ProSeal Laryngeal Mask Airway, LTS-D and I-gel in Mechanically Ventilated Patients
Official title: A Randomized Controlled Trial Comparing Proseal Laryngeal Mask Airway, I-gel Airway and Laryngeal Tube Suction-D in Mechanically Ventilated Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Morbidity
Keywords: ProSeal LMA
LTS-D
i-gel
Lead sponsor: Government Medical College, Haldwani
Sponsor class: OTHER
First posted: 2016-08-24
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Number of Insertion attempts
timeFrame: 10 mins
Secondary outcomes:
measure: Grading of insertion of device by Easy or Difficult
timeFrame: 10 min
measure: Time taken for placement of device
timeFrame: 10 min
measure: Airway sealing pressure
timeFrame: 10 min
measure: Number of attempts of gastric tube placement
timeFrame: 20 min
measure: Complication
timeFrame: 120 min
Other outcomes:
Locations:
Study officials:
affiliation: Professor
name: Geeta Bhandari, MD
role: PRINCIPAL_INVESTIGATOR
References: