| CTRI Number |
CTRI/2016/10/007407 [Registered on: 25/10/2016] Trial Registered Prospectively |
| Last Modified On: |
25/10/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparison of 2 different blades (one with videocamera and other without camera) to place the tube in the trachea for anaesthesia in children below 1 year of age. |
|
Scientific Title of Study
|
Comparison of CMAC videolaryngoscope with conventional miller blade for intubation in lateral position in neonates and infants |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Divya Jain |
| Designation |
Associate Professor |
| Affiliation |
Poatgraduate Institute of medical education and research |
| Address |
Department of anaesthesia, PGIMER, Sector 12, Chandigarh
House no-3034, sector-21-D,Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087008020 |
| Fax |
|
| Email |
jaindivya77@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Jain |
| Designation |
Associate Professor |
| Affiliation |
Poatgraduate Institute of medical education and research |
| Address |
Department of anaesthesia, PGIMER, Sector 12, Chandigarh
House no-3034, sector-21-D,Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087008020 |
| Fax |
|
| Email |
jaindivya77@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Jain |
| Designation |
Associate Professor |
| Affiliation |
Poatgraduate Institute of medical education and research |
| Address |
Department of anaesthesia, PGIMER, Sector 12, Chandigarh
House no-3034, sector-21-D,Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087008020 |
| Fax |
|
| Email |
jaindivya77@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of medical education and research, Sector 12, Chandigarh, 160012 |
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
Sector 12, chandigarh, 160012 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Divya Jain |
Postgraduate institute of medical education and research |
Department of anaesthesia, PGIMER, Sector 12, chandigarh
Chandigarh
CHANDIGARH |
7087008020
jaindivya77@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Cmmittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
undergoing surgery under general anaesthesia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CMAC group |
Child will be intubated with CMAC MILLER videolaryngoscope in lateral position |
| Comparator Agent |
Miller laryngoscope |
child will be intubated in lateral position with miller bade |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
1.00 Year(s) |
| Gender |
Both |
| Details |
neonates and infants undergoing surgery under general anaesthesia requiring endotracheal tube placement |
|
| ExclusionCriteria |
| Details |
raised intracranial pressure, high risk forpulmonary aspiration of gastric contents such asgastric outlet obstruction and bowel stasis, coagulopathyand presence of any pathology of head and neck would be excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intubation difficulty score |
1 minute after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time taken to intubate, laryngoscopic view, ease of intubation and success rate of intubation |
1 minute after intubation |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/11/2016 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
We wish to compare the intubation difficulty score , success rate, time to intubate using conventional miller and CMAC miller videolaryngoscope in neonates and infants undergoing surgery under general anaesthesia. We need to recruit 80 patients for the study |