| CTRI Number |
CTRI/2024/12/078423 [Registered on: 23/12/2024] Trial Registered Prospectively |
| Last Modified On: |
26/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two different methods to inflate cuff of windpipe tube in children |
|
Scientific Title of Study
|
Safety and efficacy of two different methods of endotracheal tube cuff inflation in children |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Noopur Jani |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Kidney Disease and Research centre,Institute of Transplantation Sciences,Ahmedabad |
| Address |
Department of Anaesthesia and Critical care, IKDRC-ITS, Civil Hospital Campus, Asarwa, Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
09428383183 |
| Fax |
|
| Email |
noopurnaik89@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Noopur Jani |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Kidney Disease and Research centre,Institute of Transplantation Sciences,Ahmedabad |
| Address |
Department of Anaesthesia and Critical Care, IKDRC-ITS, Civil hospital campus, Asarwa, Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
09428383183 |
| Fax |
|
| Email |
noopurnaik89@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Noopur Jani |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Kidney Disease and Research centre,Institute of Transplantation Sciences,Ahmedabad |
| Address |
Department of Anaesthesia and Critical Care, IKDRC-ITS, Civil hospital Campus, Asarwa, Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
09428383183 |
| Fax |
|
| Email |
noopurnaik89@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self & Institute of Kidney Disease and Research Centre, Institute of Transplantation Sciences,Ahmedabad |
|
|
Primary Sponsor
|
| Name |
Institute of kidney disease and research centre Institute of Transplantation Sciences |
| Address |
Department of Anaesthesia and Critical care,Institute of Kidney disease and research centre,Institute of Transplantation sciences,Civil hospital campus,Asarwa,Ahmedabad-380016
Gujarat State,INDIA |
| 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 |
| DrNoopur Jani |
Institute of Kidney Disease and Research centre, Institute of transplantation sciences |
Civil hospital Campus,Asarwa,Ahmedabad-380016
Ahmadabad
GUJARAT |
09428383183
noopurnaik89@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GUTS-IEC |
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 |
Cuff inflation by manual palpation of leak method
|
Inflation of cuff with air by 2 cc syringe till no leak palpable in suprasternal notch in neck area while holding continuous airway pressure of 20 cm of H2O with gas flow of 6L/min. Measurement of intra cuff pressure using AMBU manometer. Check adequate seal by supraglottic capnometry.
Again measurement of intra-cuff pressure. Note intra-cuff pressure,amount of air,airway morbidity |
| Intervention |
Cuff inflation by Stethoscope guided removal of air method |
Inflation of cuff with air using 2cc syringe, followed by placement of stethoscope in suprasternal notch in neck area,followed by removal of air in small increments till leak is heard while holding continuous airway pressure of 20 cm of H2O with gas flow @ 6L/min.Measurement of intra-cuff pressure by AMBU manometer.Check adequate seal by supra glottic capnometry.Again measure intra-cuff pressure. Note intra-cuff pressure,amount of air,airway morbidity |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
All children of 3-8 years of age, of either sex, ASA grade I/II posted for open urogenital surgery lasting for duration of 1-4 hrs under general anaesthesia using endotracheal intubation |
|
| ExclusionCriteria |
| Details |
1.Patients with predicted difficult airway, airway abnormalities,reactive airway
2.Patients with lung disease, risk of pulmonary aspiration,requiring prolonged ventilation
3.Patients with previous sore throat, hoarseness of voice, respiratory infection in last one week,surgery requiring airway manipulation.
4.Not willing to participate
5.Patients requiring nitrous oxide as anaesthesia gas
6.Not fitting endotracheal tube size as selected by Duracher formula(age/4+3.5)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare percentage of intracuff pressure within recommended range (20-30 cm of H2O) in both groups |
Initially and after supraglottic capnometry |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare airway morbidity related to overinflation of cuff like sore throat (assessed at 4 and 6 hrs postoperatively) stridor, croup, laryngospasm (assessed in immediate postoperative period) in both groups. |
Immediately,4 and 6 hours after surgery |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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
Modification(s)
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/01/2025 |
| 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="2"
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 - NO
|
|
Brief Summary
|
Cuffed endotracheal tubes are considered standard of care in children <8 years of age. Pre-requisite is to maintain intra-cuff pressure<30 cm of H2O.Measurement of cuff pressure by manometer is gold standard but not feasible in every clinical scenario with high turnover rate. Best practical solution is to inflate cuff just enough to achieve adequate seal. So the study will compare and objectively justify two different methods of cuff inflation (Manual palpation, Stethoscope guided removal of air) in terms of achieving minimal intra-cuff pressure with adequate seal. A prospective double blind, randomized, paralleled ,active controlled study will recruit children of 3-8 years undergoing surgery under general anaesthesia using endotracheal tube. Intra-cuff pressure will be measured by AMBU manometer. Adequacy of seal will be ensured by supraglottic capnometry. Statistical analysis will be done using ANNOVA test, chi-square and fischer exact test. |