| CTRI Number |
CTRI/2024/02/062632 [Registered on: 14/02/2024] Trial Registered Prospectively |
| Last Modified On: |
13/02/2024 |
| 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
|
study to know which technique of extubation is better in prevention of cough after extubation in children posted for general surgeries |
|
Scientific Title of Study
|
Comparison of the Standard Awake and Head elevated No touch technique of extubation to prevent respiratory complications during emergence from general anaesthesia in paediatric patients: A randomised controlled trial. |
| Trial Acronym |
Not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Ref.no:68/AIIMS/Pat/RD/2023 dated 5-12-2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gokul Rangan |
| Designation |
Anaesthesia Academic Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Patna |
| Address |
Department of Anaesthesiology,
AIIMS Patna,
Phulwari sharif,Patna,
Bihar.
801507
India.
Patna
BIHAR
801507
India |
| Phone |
9940018890 |
| Fax |
|
| Email |
gokulsam219@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhyuday Kumar |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Science Patna |
| Address |
Room no 506,B5A OT complex,IPD Building,Dept of Anaesthesiology, All India Institute of Medical Science Patna Phulwari Sharif Patna
Patna
BIHAR
801507
INDIA
Patna
BIHAR
801507
India |
| Phone |
9013512403 |
| Fax |
|
| Email |
drabhyu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gokul Rangan |
| Designation |
Anaesthesia Academic Junior Resident |
| Affiliation |
All India Institute of Medical Sciences,Patna |
| Address |
Department of Anaesthesiology,
AIIMS Patna,
Phulwari sharif,Patna,
Bihar.
801507
India.
Patna
BIHAR
801507
India |
| Phone |
9940018890 |
| Fax |
|
| Email |
gokulsam219@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology,All India Institute of Medical Sciences Patna, Phulwari Sharif,Bihar,801507,India. |
|
|
Primary Sponsor
|
| Name |
AIIMS Patna |
| Address |
Department of Anaesthesiology,AIIMS Patna,BIHAR,INDIA. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of Anaesthesiology AIIMS Patna |
AIIMS Patna,BIHAR,INDIA |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Gokul Rangan |
All India Institute of Medical Sciences, Patna |
Department of Anaesthesiology,5th Floor OT complex ,IPD building ,AIIMS Patna,Bihar,India.
Patna
BIHAR |
9940018890
gokulsam219@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ,AIIMS PATNA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
no touch group |
Head Elevated (15 degree) No Touch Technique of extubation in Lateral position |
| Comparator Agent |
standard awake group |
Standard Awake Technique of extubation in supine position |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
1) ASA physical status 1,2 and 3
2) Age ≤ 5 years
3) Weight ≤ 20 kg
|
|
| ExclusionCriteria |
| Details |
1.Refusal by the guardian
2.Anticipated difficult airway including Mallampati classification mandibular
protrusion movement disorder of atlanto-occipital joint increased tongue
thickness reduced mandibular space and abnormal thyromental distance
3.Children who had previously failed conventional direct laryngoscopy
4.Duration of surgery less than 1 hours
5.History of cardiopulmonary disease and Recent upper respiratory infection (less
than two week)
6.Continuous treatment for allergic rhinitis asthma obstructive sleep apnea or
severe snoring
7.Weight-for-height greater than 3 standard deviations above WHO Child
Growth Standards median
8.other factors includes Patient posted for emergency procedures,
Head and Neck surgery
9.Any surgical procedure with expected postoperative ICU admission |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence of moderate to severe cough using the
Modified Minogue scale |
T1-Immediately after extubation
T2-1 minute after extubation
T3-10 minutes after extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Mean Blood Pressure
2.Heart Rate
3.Respiratory Rate
4.Sedation agitation score after extubation.
5.choking
6.laryngospasm
7.posterior tongue drop
8.Breath holding
9.hypoxemia oxygen saturation less than ninetyfour percentage |
For 1,2 and 3 - At the time of switching off inhaled anaesthetic agents,Before extubation,Immediately after extubation,one minute,Ten minute after extubation.
For 4,5,6,7,8,and 9-Immediately after extubation,one minute,Ten minute after extubation. |
|
|
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)
|
29/02/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [gokulsam219@gmail.com].
- For how long will this data be available start date provided 23-10-2025 and end date provided 23-10-2030?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Patients can be awake or deeply sedated when having tracheal extubation. Both approaches have their advantages and disadvantages. The disadvantage of deep extubation is aspiration, upper airway obstruction and laryngospasm. The advantages of head elevated lateral position are fewer episodes of desaturation, decreased upper airway obstruction and less chance of aspiration. Several harmful respiratory side effects and derangements in hemodynamic parameters may occur during emergence from general anaesthesia. Pediatric populations experience these occurrences more frequently. Cough is one of the more frequent side effects of the respiratory system, particularly in children.In this study we compare standard awake technique of extubation in supine position with "Head elevated No touch technique in lateral position" method of extubation,where patients are kept in a lateral position with 15-degree head elevation. No Touch refers to avoidance of any tactile stimulation until the spontaneous opening of eyes occurs. We expect that the “Head elevated No touch technique†of extubation in lateral position would be a better technique of extubation in the prevention of respiratory side effects like choking, laryngospasm, posterior tongue drop, Breath holding and hypoxemia (Spo2 < 94%) compared to “Standard Awake technique†of extubation in supine position in the paediatric population, thus providing a better alternative method extubation in the paediatric population (less than five years of age).Parameters that will be recorded in this study are following:
1.Incidence of moderate to severe cough using the Modified Minogue scale. 2.Incidence of other respiratory adverse effects like choking, laryngospasm, posterior tongue drop, Breath holding and hypoxemia (Spo2 < 94%). 3.The changes in hemodynamic parameters (Mean Blood Pressure, Heart Rate and Respiratory Rate). 4.Sedation agitation score after extubation. |