MedPath

Anaesthesia and complications

Phase 1
Not yet recruiting
Conditions
ASA grade I and II
Registration Number
CTRI/2018/07/014774
Lead Sponsor
Govt Medical College Amritsar
Brief Summary

The laryngeal mask airway is one of the airway devices that has gained popularity during the past decade.LMA cuff inflation with the normal recommended injection volume results in the residual volume of the cuff being exceeded during anaesthesia resulting in severe and even fatal injury including tracheal pain or stridor.  A variety of   media are used for cuff inflation which varies with their efficacy to maintain a stabilised cuff pressure and to prevent post intubation-related emergence phenomenon. This will be a prospective randomized double blind study which will be done to compare the effects of laryngeal mask airway (LMA) supreme cuff inflation with air, air: oxygen mixture and oxygen: nitrous oxide mixture in adults. The study will be carried out on 120 adults of ASA grade I and II who will be divided into three groups of 40 each. Supreme LMA cuff inflation will use Air only in group A, Oxygen: Air mixture in Group OA andOxygen: Nitrous oxide mixture in Group ON. All the groups will be compared with respect to changes in cuff pressure intraoperatively with different gas composition used to inflate the LMA Supreme with a manometer and

post-operative pharyngolaryngeal morbidity. The observations will be recorded on the proforma and the results will be statistically analysed in the three groups.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
120
Inclusion Criteria

ASA Grade I and II Age 18 to 60.

Exclusion Criteria
  • Inadequate mouth opening 2.
  • Patient with BMI > 35 kg/m2 3.
  • Anticipated difficult airway.
  • Patient having diseases with risk of aspiration like gastro oesophageal reflux disease, hiatus hernia.
  • Oropharyngeal pathology 6.
  • ASA grading III, IV 7.
  • Cervical spine pathology 8.

Study & Design

Study Type
BA/BE
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To compare the changes in cuff pressure intraoperatively with different gas composition (Air, Air: Oxygen mixture, Oxygen: Nitrous oxide mixture) used to inflate the LMA Supreme by cuff pressure monitor.(Manometer)The primary outcome will be compare the changes in cuff pressure intraoperatively with different gas composition (Air, Air: Oxygen mixture, Oxygen: Nitrous oxide mixture) used to inflate the LMA Supreme by cuff pressure monitor.(Manometer)
Secondary Outcome Measures
NameTimeMethod
a. To compare the effect of LMA Supreme cuff pressure change on intraoperativeventilator parameters

Trial Locations

Locations (1)

Government medical collegel, Amritsar

🇮🇳

Amritsar, PUNJAB, India

Government medical collegel, Amritsar
🇮🇳Amritsar, PUNJAB, India
Dr Ranjana
Principal investigator
9815654332
rkhetarpal9@hotmail.com

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