| CTRI Number |
CTRI/2020/01/022970 [Registered on: 27/01/2020] Trial Registered Prospectively |
| Last Modified On: |
03/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of two devices for management of airway during anaesthesia in children |
|
Scientific Title of Study
|
A randomised controlled study to compare oropharyngeal leak pressure in two different second generation supraglottic airway devices in children under general anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashutosh singh |
| Designation |
Post graduate student |
| Affiliation |
Lady hardinge medical college |
| Address |
Department of anaesthesia, lady hardinge medical college, shaheed bhagat singh marg
Central
DELHI
110001
India |
| Phone |
9990999198 |
| Fax |
|
| Email |
ASHUTOSHSINGHRAJAWAT@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil kumar sinha |
| Designation |
Director professor |
| Affiliation |
Lady hardinge medical college |
| Address |
Department of anaesthesia, lady hardinge medical college, shaheed bhagat singh marg
Central
DELHI
110001
India |
| Phone |
9868493597 |
| Fax |
|
| Email |
sunilsinha248@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunil kumar sinha |
| Designation |
Director professor |
| Affiliation |
Lady hardinge medical college |
| Address |
Department of anaesthesia,lady hardinge medical college,shaheed bhagat singh marg
Central
DELHI
110001
India |
| Phone |
9868493597 |
| Fax |
|
| Email |
sunilsinha248@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lady hardinge medical college,new delhi |
|
|
Primary Sponsor
|
| Name |
Llady hardinge medical college |
| Address |
Department of anaesthesia,
Lady hardinge medical college,
Shaheed bhagat singh marg |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| ashutosh singh |
Operation theatre in lady Hardinge medical college and associate hospitals |
Department of anaesthesia/ operation theatre/ lady hardinge medical college and associate hospitals
Central
DELHI |
9990999198
ASHUTOSHSINGHRAJAWAT@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ethics committee for human research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa, (2) ICD-10 Condition: H60-H95||Diseases of the ear and mastoid process, (3) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, (4) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (5) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue, (6) ICD-10 Condition: Q00-Q99||Congenital malformations, deformations and chromosomal abnormalities, (7) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes, (8) ICD-10 Condition: A00-B99||Certain infectious and parasitic diseases, (9) ICD-10 Condition: D50-D89||Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
I gel |
device will be inserted and adequacy of ventilation and oropharyngeal leak pressure will be measured |
| Intervention |
LMA supreme |
device will be inserted and adequacy of ventilation and oropharyngeal leak pressure will be measured |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
14.00 Month(s) |
| Gender |
Both |
| Details |
1. Either sex
2. less than or equal to 10kg of body weight
3. ASA grade I & II
4. Adequate nutritional status ( -2 to +2 z scores for weight for age)
|
|
| ExclusionCriteria |
| Details |
1. Congenital airway abnormality
2. Anticipated difficult airway
3. Upper respiratory infections
4. Risk of aspiration (gastrointestinal obstruction, pyloric stenosis)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean ± SD of Oropharyngeal leak pressure (OLP) in i-gel and LMA supreme. |
after successful insertion of device |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients in whom device could be inserted easily in both groups |
After successful insertion of device |
| Proportion of successful insertion at 1st attempt in both groups |
After successful insertion of device |
| Proportion of number of manipulations in both groups |
After successful insertion of device |
| Proportion of number of insertion attempts in both groups |
After successful insertion of device |
| Mean ± SD of insertion time (seconds) in both groups |
After successful insertion of device |
| Fiberoptic view of larynx grading in both groups |
After successful insertion of device |
| Proportion of perioperative complications in both groups |
After successful removal of device |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/01/2020 |
| 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="1"
Months="3"
Days="8" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
result will be published in scientific journal |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Supraglottic airway device (SAD) is commonly used in adults and children to secure airway during general anaesthesia. Different types of SAD are used. I-gel and laryngeal mask airway supreme (LMA supreme) are 2nd generation single use SADs with an integral bite block, the difference being the cuff. Whereas the LMA supreme has an inflatable cuff, i-gel is made from medical grade thermoplastc elastomer. I-gel has been designed to create a non-inflatable, anatomical seal of the pharyngeal, laryngeal and perilaryngeal structures whilst avoiding compression trauma. LMA supreme has two seals: first seals the oropharynx and second the upper esophageal sphincter. The importance of the second seal is significant: it can minimize gastric insufflation and reduce the risk of aspiration. A drain tube in both devices, which lies over the top of the oesophagus when the SAD is correctly positioned, may be used to: assist insertion, enable access to the stomach, alert the user to presence of regurgitation and enable gastric contents to safely bypass the oropharynx and exit the patient. Optimal placement of SADs may be confirmed by oropharyngeal leak pressures (OLP) and fiberoptic view. SADs are manufactured to conform to the anatomy of adult larynx, but paediatric larynx is different anatomically from the adult. The paediatric sizes of SADs are miniaturized versions of the adult device and may not conform to the paediatric anatomy thus resulting in suboptimal ventilation. Several studies have compared the i-gel and LMA supreme in adults. However, in children (less than or equal to 10kg) there is paucity of literature regarding which SAD provides the best fit as evidenced by OLP. Hence the present study will be undertaken to compare the oropharyngeal leak pressure (OLP) of i-gel and LMA supreme in the airway management of children |