| CTRI Number |
CTRI/2013/08/003898 [Registered on: 13/08/2013] Trial Registered Retrospectively |
| Last Modified On: |
03/02/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical trial comparing the advantage of use of i- gel over ProSeal airway device in children |
|
Scientific Title of Study
|
Comparison of i-gel with ProSeal laryngeal mask airway for airway management in paediatric patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NIRUPA R |
| Designation |
post graduate student |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE HOSPITAL , SECTOR -32 , CHANDIGARH |
| Address |
ANAESTHESIA OFFICE, FLOOR NO. 5,GOVERNMENT MEDICAL COLLEGE HOSPITAL , SECTOR -32
Chandigarh
CHANDIGARH
160031
India |
| Phone |
9888239612 |
| Fax |
|
| Email |
niru27r@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF SATINDER GOMBAR |
| Designation |
HEAD OF ANAESTHESIA DEPARTMENT |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE HOSPITAL , SECTOR -32 , CHANDIGARH |
| Address |
ANAESTHESIA OFFICE, FLOOR NO. 5,GOVERNMENT MEDICAL COLLEGE HOSPITAL , SECTOR -32
Chandigarh
CHANDIGARH
160031
India |
| Phone |
9646121520 |
| Fax |
|
| Email |
dr_sgombar@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NIRUPA R |
| Designation |
post graduate student |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE HOSPITAL , SECTOR -32 , CHANDIGARH |
| Address |
ANAESTHESIA OFFICE, FLOOR NO. 5,GOVERNMENT MEDICAL COLLEGE HOSPITAL , SECTOR -32
Chandigarh
CHANDIGARH
160031
India |
| Phone |
9888239612 |
| Fax |
|
| Email |
niru27r@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT MEDICAL COLLEGE AND HOSPITAL, CHANDIGARH |
|
|
Primary Sponsor
|
| Name |
GOVERNMENT MEDICAL COLLEGE AND HOSPITAL |
| Address |
GOVERNMENT MEDICAL COLLEGE AND HOSPITAL,SECTOR 32, CHANDIGARH |
| 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 |
| NIRUPA R |
GOVERNMENT MEDICAL COLLEGE AND HOSPITAL |
DEPARTMENT OF ANAESTHESIA , FLOOR NO. 5 , GOVERNMENT MEDICAL COLLEGE AND HOSPITAL, SECTOR 32-A
Chandigarh
CHANDIGARH |
9888239612
niru27r@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL RESEARCH AND ETHICAL COMMITTEE,GOVERNMENT MEDICAL COLLEGE AND HOSPITAL,CHANDIGARH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
peadiatric patient between age 2- 6 years scheduled for short duration elective surgeries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
i-gel |
Comparison of i-gel with ProSeal laryngeal mask airway for airway management in paediatric patients |
| Comparator Agent |
ProSeal laryngeal mask airway |
Comparison of i-gel with ProSeal laryngeal mask airway for airway management in paediatric patients |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1.American Society of Anesthesiologist (ASA) physical status I/II of either sex
2.Age group of 2-6 years
3.Weight between 10-30 kg
4.Scheduled for short duration elective surgeries requiring general anaesthesia with controlled ventilation
|
|
| ExclusionCriteria |
| Details |
1.Upper respiratory tract infection
2.Anticipated difficult airway
3.Children at increased risk of aspiration - Gastro esophageal reflux disease, non fasting status
4.Cardiorespiratory or cerebrovascular disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oropharyngeal seal pressure |
just after insertion of the airway |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Number of Attempts
Insertion time (seconds)
Ease of insertion of Supraglottic airway device
Ease of orogastric tube insertion
Quality of the initial airway
Malposition
Fibreoptic grading
Haemodynamic parameter including Pulse rate,Systolic blood pressure,Diastolic blood pressure,mean arterial pressure
Ventilatory parameter:SpO2 %
EtCO2 (mmHg),Peak airway pressure(cm/H2O),Mean airway pressure(cm/H2O),Resistance( cm H2O/L/sec),Compliance L/cm H2O,Minute ventilation(L/min)
|
hemodynamic parameters baseline , after induction,2 mins and 5 mins after insertion , after removal of the device , ventilatory parameters at 2 minutes and 5 minutes after insertion of the device |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 4 |
|
Date of First Enrollment (India)
|
01/04/2013 |
| 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
Modification(s)
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The study is a prospective randomised and controlled study comparing the efficacy of I -gel and ProSeal laryngeal mask airway for airway management in 100 children between 2 to 6 years of age that will be conducted in Government medical college and Hospital, Chandigarh The primary outcome is oropharyngeal seal pressure in these two devices. The secondary outcomes are correct positioning insertion time quality of the initial airway fibroptic view respiratory parameters including Peak airway pressure mean airway pressure minute ventilation resistance compliance mean airway pressure at two five minutes post insertion of the device and hemodynamic parameters at the start after induction 2 mins and 5 mins after insertion of the device lastly after removal of the device The data will be analysed by SPSS software kolmogorov smirnov test will be used for normality of distribution Parametric data will be assessed by unpaired t test and non parametric data by mann whitney test Data will be presented as mean SD results demographic data similar in both groups The OLP in i gel group was significantly higher than in PLMA group Time taken for successful insertion in PLMA was longer than in i gel group The quality of initial airway was found to be higher in i gel group |