| CTRI Number |
CTRI/2016/10/007390 [Registered on: 20/10/2016] Trial Registered Retrospectively |
| Last Modified On: |
18/10/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ease of airtraq use for insertion of tube in windpipe of children |
|
Scientific Title of Study
|
An observational study of feasibility of tracheal intubation using airtraq in paediatric population |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LTMMC/IEC/59/15 dated 30.09.2015 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Devendra Thakare |
| Designation |
Assistant Professor |
| Affiliation |
LTMMC and LTMGH |
| Address |
503 new RMO doctors quarters sion hospital campus SION west
Mumbai MAHARASHTRA 400022 India |
| Phone |
09892954998 |
| Fax |
|
| Email |
devendra.thakare@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Anila Malde |
| Designation |
Professor |
| Affiliation |
LTMMC and LTMGH |
| Address |
Department of Anaesthesia,LTMMC and LTMGH, Dr. Babasaheb Ambedkar Road, Sion West, Mumbai, Maharashtra 400022
Mumbai MAHARASHTRA 400022 India |
| Phone |
9821085730 |
| Fax |
|
| Email |
dradmalde@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Devendra Thakare |
| Designation |
Assistant Professor |
| Affiliation |
LTMMC and LTMGH |
| Address |
503,new RMO doctors quarters,sion hospital campus,SION west
Mumbai MAHARASHTRA 400022 India |
| Phone |
9892954998 |
| Fax |
|
| Email |
devendra.thakare@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lokmanya Tilak Municipal Medical College & General Hospital, Dr. Babasaheb Ambedkar Road, Sion West, Mumbai, Maharashtra - 400022 |
|
|
Primary Sponsor
|
| Name |
LTMMC and LTMGH |
| Address |
Department of Anaesthesia,LTMMC and LTMGH, Dr. Babasaheb Ambedkar Road, Sion West, Mumbai, Maharashtra 400022 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DR DEVENDRA THAKARE |
Lokmanya Tilak Municipal Medical College & General Hospital |
Dr. Babasaheb Ambedkar Road, Sion West, Mumbai, Maharashtra 400022 Mumbai MAHARASHTRA |
02224049023
doasionhospital@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| LTMMC AND LTMGH STAFF AND RESEARCH SOCIETY (ESTD.1967) Bombay Public Trust Act. Reg. No. F/1669 of 21-9-1968, Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Age - 3 months to 18 years
Either sex
ASA I and II
Patients undergoing general anaesthesia with endotracheal intubation using airtraq
, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. American Sosciety of Anaesthesiologists I and II
2. Patients undergoing general anaesthesia with endotracheal intubation using airtraq
|
|
| ExclusionCriteria |
| Details |
1. Difficult airway or history of difficult intubation
2. Risk of gastric aspiration
3. Active upper or lower respiratory tract infection
4. Severely raised intracranial tension
5. Cyanotic heart disease
6. Non consenting parent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to intubation (TTI) in seconds |
Time to intubation : Time interval between blade entry past the lips and the appearance of first upstroke of the end-tidal CO2 tracing
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Percentage of glottis opening (POGO) score %
2. Visual analogue scores (VAS) for field of view
3. Time to best view (TTBV)
4. Visual Analogue Scale(VAS) for ease of use |
1. Percentage of glottis opening (POGO) score % : 0 to 100
2. Visual analogue scores (VAS) for field of view : 0 to 10 -point scale.
3. Time to best view (TTBV) in seconds : Time interval between blade entry past the lips and the laryngoscopist’s verbal declaration that the best view for endotracheal intubation is achieved.
4. Visual Analogue Scale(VAS) for ease of use : 0 to 10 -point scale. |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/10/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Reference. White MC, Marsh CJ, Beringer RM, Nolan JA, Choi AYS, Medlock KE, Mason DG. A randomised control trial comparing the AirtraqTM optical laryngoscope with conventional laryngoscopy in infants and children. Anaesthesia 2012; 67: 226–231 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
After approval from the ethics committee, patients in the age group of 3 months to 18 years scheduled for routine surgical procedure under general anaesthesia with endotracheal intubation using airtraq (AT) will be observed during the period of the study. Any co-existing medical disease, associated congenital anomalies and airway problems and will be noted. Written valid informed consent will be taken from the respective parent or guardian. If the child can understand the nature of procedure, he or she will be explained about the study and assent will be taken. All children will receive general anaesthesia as per routine protocol followed in various operation theatres in LTMGH, Sion. This usually comprises of: - Preoperative starvation as per ASA fasting guidelines 2011
- Establishment of monitoring like electrocardiogram, pulse oximetry, capnography and non invasive blood pressure measurement
- Premedication in form of antisialogogue, sedatives and analgesic
- Either Intravenous or Inhalational induction
- Checking of adequate depth of anaesthesia
- Confirmation of adequacy of ventilation without gastric insufflation
- Administration of neuromuscular blockade
- Intubation using AT laryngoscope by experienced anaesthesiologists as per manufacturer’s instructions (appendix B)
- Sizes of AT laryngoscope used ( appendix C)
- Confirmation of proper endotracheal intubation by observation of chest expansion, auscultation of bilateral breath sounds and square wave capnogram
Following parameters will be assessed 1. Percentage of glottis opening (POGO) score: denotes visual estimation of laryngeal opening in score of 0% to 100%. (appendix A) A POGO score of 100 = full visualisation of larynx from the interarytenoid notch to anterior commissure of the vocal cords; 0 = none of the glottis opening is seen. 2. Visual analogue scores (VAS) for field of view : 0 to 10 -point scale. 0 = poor, 10 = excellent 3. Time to best view (TTBV): time interval between blade entry past the lips and the laryngoscopist’s verbal declaration that the best view for endotracheal intubation is achieved. 4. Time to intubation (TTI): time interval between blade entry past the lips and the appearance of first upstroke of the end-tidal CO2 tracing. 5. Visual Analogue Scale(VAS) for ease of use : 0 to 10 -point scale. 0 = poor, 10 = excellent Failed attempts, if any will be noted. Failed attempt is considered when: - Inability to pass endotracheal tube within 60 seconds of AT blade entry past the lips
- Abandoning the intubation attempt due to decrease in oxygen saturation < 94%
- Change of premounted endotracheal tube
In our set up more than two intubation attempts with any device are not allowed. Failed intubation is considered when successful intubation with airtraq is not possible. Difficulties encountered e.g. anterior or posterior impingement of ET tube; loss of visualization due to “fogging†or “red-out†will be noted. Optimization manoeuvres required (if any) will be noted. Commonly used optimization manoeuvres are: · repositioning the head or the need for a second assistant to aid tracheal intubation · use of external laryngeal manipulation Complications associated with laryngoscopy-intubation, if any will be noted STATISTICAL ANALYSIS Data which are normally distributed will be presented as means ± standard deviation (M ± SD) for continuous variables. Data which is not normally distributed will be presented as median with interquartile range (median with IQR). A subgroup analysis will be done depending on the size of the AT used. Any difference between the parameters will be studied using ANOVA test. Any significant difference in the parameters in individual group will be compared using unpaired t test. Categorical data like failed attempts, difficulties encountered in each subgroup will be studied by using Chi square test or Fisher’s exact test. |