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Clinical Trials/CTRI/2025/05/087275
CTRI/2025/05/087275Not yet recruitingPhase 4

A Study To Assess Efficacy Of Blockbuster LMA For Ventilation And Intubation

Dr Shahil ahmed1 site in 1 country200 target enrollmentStarted: May 29, 2025Last updated:

Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Enrollment
200
Locations
1
Primary Endpoint
•To study the first attempt successful intubation done using blockbuster LMAs and NG insertion.

Study Overview

Brief Summary

The present study is a Prospective, Randomized and Comparative study done after approval of Institutional Ethics Committee in patients satisfying all inclusion and exclusion Criteria planned for short surgeries under GA. Material used were Blockbuster LMA, Anaesthesia workstation, suction apparatus, Laryngoscope and ET Tubes of various sizes. After careful preoperative assessment of all patients’ standard monitors including NIBP, ECG, and pulse oximeter will be attached to the patient. The study population is divided into single group of 200 patients. Group B used Blockbuster as ventilatory device. In the operating room, an 18G IV cannula is inserted into both hands. Ringer lactate solution is infused at 10ml/kg. Patients receive 100% oxygen for 3 minutes, followed by premedication. Standard monitoring is connected. Anesthesia is induced with propofol and vecuronium and maintained with oxygen, nitrous oxide, and sevoflurane after introducing allocated SAD. parameters like-successful insertion time, number of attempts of insertion, oropharyngeal leak pressure and vitals like- pulse rate, blood pressure, SpO2 , EtCO2 and ventilator parameters will be noted before induction of anesthesia, throughout surgery and immediately after removal of the device after completion of surgery

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Not Applicable

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 1.Patients giving informed written consent for participation in the study.
  • 2.Patients posted for surgery under general anesthesia.
  • 3.Age of the patient between 18-65 of either sex.
  • 4.Patients belonging to American Society of Anaesthesiology class I and II.
  • 5.Patients belonging to Modified Mallampatti Score of class I and II.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

•To study the first attempt successful intubation done using blockbuster LMAs and NG insertion.

Time Frame: 24hrs

Secondary Outcomes

  • •The time of LMA insertion & LMA removal.(•Any intra-op & post-op complications occurring using LMAs.)

Investigators

Sponsor
Dr Shahil ahmed
Sponsor Class
Other [self]

Study Sites (1)

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