| CTRI Number |
CTRI/2018/07/014774 [Registered on: 09/07/2018] Trial Registered Prospectively |
| Last Modified On: |
09/07/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Anaesthesia and complications |
|
Scientific Title of Study
|
COMPARISON OF EFFECTS OF LARYNGEAL MASK AIRWAY (LMA) SUPREME CUFF INFLATION WITH AIR, AIR: OXYGEN MIXTURE AND OXYGEN: NITROUS OXIDE MIXTURE IN ADULTS: A RANDOMIZED DOUBLE BLIND STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ranjana |
| Designation |
Professor |
| Affiliation |
Government Medical College, Amritsar |
| Address |
Department of anaesthesia and critical care, Government Medical College, Amritsar
House Number 9, Garden Colony , Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
9815654332 |
| Fax |
|
| Email |
rkhetarpal9@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ranjana |
| Designation |
Professor |
| Affiliation |
Government Medical College, Amritsar |
| Address |
Department of anaesthesia, Government Medical College, Amritsar
House Number 9, Garden Colony , Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
9815654332 |
| Fax |
|
| Email |
rkhetarpal9@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kirti |
| Designation |
Junior Resident |
| Affiliation |
Govt Medical College, Amritsar |
| Address |
Dept of Anaesthesia,Govt Medical College Amritsar
67, Guru Nanak Avenue, Majitha Road , Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
9914407952 |
| Fax |
|
| Email |
kirtijangwal1767@gmail.com |
|
|
Source of Monetary or Material Support
|
| Deptt of Anaesthesia, Govt Medical College, Amritsar |
|
|
Primary Sponsor
|
| Name |
Govt Medical College Amritsar |
| Address |
Govt Medical Colleege,
Circular Road
Amritsar |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ranjana |
Government medical collegel, Amritsar |
Department of Anaesthesia and critica care
amritsar
Amritsar
PUNJAB |
9815654332
rkhetarpal9@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Instituional Ethical Committee |
Approved |
| Institutional ethical committe |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA grade I and II , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
first arm- inflation of LMA supreme cuff with AIR |
The LMA cuff will be inflated with air to obtain a cuff pressure of 40 cm H2O with the help of aneroid cuff pressure manometer attached to the pilot balloon. The volume of gas inflated will be noted. Successful insertion will be assessed by chest expansion and capnography. At cuff pressure of 40 cm H2O, oropharyngeal leak pressure (OLP) will be checked by closing adjustable pressure limiting valve at fixed gas flow of 3 L/min. |
| Comparator Agent |
LMA supreme cuff inflation with Oxygen and nitrous oxide |
Third arm- LMA cuff will be inflated with oxygen and nitrous oxide to obtain a cuff pressure of 40 cm H2O with the help of aneroid cuff pressure manometer attached to the pilot balloon. The volume of gas inflated will be noted. Successful insertion will be assessed by chest expansion and capnography. At cuff pressure of 40 cm H2O, oropharyngeal leak pressure (OLP) will be checked by closing adjustable pressure limiting valve at fixed gas flow of 3 L/min. |
| Intervention |
not applicable |
not applicable |
| Comparator Agent |
Second arm-LMA Supreme cuff inflation with AIR and OXYGEN |
The LMA cuff will be inflated with air and oxygen to obtain a cuff pressure of 40 cm H2O with the help of aneroid cuff pressure manometer attached to the pilot balloon. The volume of gas inflated will be noted. Successful insertion will be assessed by chest expansion and capnography. At cuff pressure of 40 cm H2O, oropharyngeal leak pressure (OLP) will be checked by closing adjustable pressure limiting valve at fixed gas flow of 3 L/min. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade I and II
Age 18 to 60
|
|
| ExclusionCriteria |
| Details |
1. Inadequate mouth opening
2. Patient with BMI > 35 kg/m2
3. Anticipated difficult airway.
4. Patient having diseases with risk of aspiration like gastro oesophageal reflux disease, hiatus hernia.
5. Oropharyngeal pathology
6. ASA grading III, IV
7. Cervical spine pathology
8. Pregnancy
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
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)
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
a. To compare the effect of LMA Supreme cuff pressure change on intraoperative
ventilator parameters
b. Post-operative pharyngolaryngeal morbidity
c. Occurrence of the rare complications of LMA insertion such as recurrent laryngeal
nerve palsy, hypoglossal nerve palsy, and lingual nerve palsy.
|
till 24 hours post operatively |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
12/07/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="6" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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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 and Oxygen: 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. |