| CTRI Number |
CTRI/2026/01/101641 [Registered on: 20/01/2026] Trial Registered Prospectively |
| Last Modified On: |
19/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia Preventive Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing two breathing methods to improve lung health in children having keyhole surgery |
|
Scientific Title of Study
|
Evaluation of Spirometry-Measured Tidal volume with Low Tidal volume on Lung Function in Pediatric Patients Undergoing Laparoscopic Surgery: A Randomized Controlled double blinded Trial at AIIMS Nagpur |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DEEPAK MODI |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences Nagpur |
| Address |
1st Floor OPD building Department of Anaesthesiology
Nagpur MAHARASHTRA 441108 India |
| Phone |
9964592611 |
| Fax |
|
| Email |
deepakmodi354@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DEEPAK MODI |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences Nagpur |
| Address |
1st Floor OPD building Department of Anaesthesiology
MAHARASHTRA 441108 India |
| Phone |
9964592611 |
| Fax |
|
| Email |
deepakmodi354@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DEEPAK MODI |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences Nagpur |
| Address |
1st Floor OPD building Department of Anaesthesiology
MAHARASHTRA 441108 India |
| Phone |
9964592611 |
| Fax |
|
| Email |
deepakmodi354@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences Nagpur |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Nagpur |
| Address |
Dept. of anesthesiology and critical care AIIMS Nagpur 1st floor OPD Building AIIMS Nagpur |
| 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 DEEPAK MODI |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES NAGPUR |
1st Floor OPD building Department of Anaesthesiology Nagpur MAHARASHTRA |
9964592611
deepakmodi354@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee AIIMS Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
lung function after mechanical ventilation |
| Patients |
(1) ICD-10 Condition: Z759||Unspecified problem related to medical facilities and other health care, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Low Tidal Volume |
Patients on Mechanical Ventilation will be ventilated with Tidal Volume of 6ml/kg of predicted body weight for the duration of surgery at least for more than 2 hours |
| Intervention |
Spirometry-Measured Tidal Volume |
Patients on Mechanical Ventilation will be Ventilated with Tidal Volume obtained by Pre-operative Spirometer for the duration of surgery at least for more than 2 hours |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
a) Patients aged between 6 years and 12 years of age
b) ASA 1 and 2 patients coming for laparoscopic surgery lasting at least 2 hours
|
|
| ExclusionCriteria |
| Details |
1)Patients who cannot perform spirometry
2)Emergency surgeries
3)ASA grade equal to or greater than 3
4)Paediatric bariatric surgery
5)Previous lung surgery (any)
6)Need for post-op mechanical ventilation
• Persistent hemodynamic instability
• History of chronic or acute lung disease
• Patients with any neuromuscular disease.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the influence of preoperative spirometry-measured Vt compared with low Vt mechanical ventilation on intra-operative lung atelectasis using ultrasound, and forced expiratory volume in 1 second (FEV1) and forced vital capacity in post operative lung among patients undergoing Laparoscopic surgery |
a) Preoperative and postoperatively at 1,6 and 24 hours after extubation FEV1 and FVC by spirometry
b) when the patient entered the operating room (time point 1, T1), 5 min after pneumoperitoneum (time point 2 T2), at the end of surgery (time point 3, T3), 1 hour after arrival in the PACU (time point 4, T4). USG lungs for atelectasis in the posterior lung region bilaterally.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="176" Sample Size from India="176"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
16/02/2026 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - Nil
- For how long will this data be available start date provided 17-07-2027 and end date provided 17-07-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
In paediatric anesthesia, a notable challenge
arises from the lack of personalized mechanical ventilation strategies tailored
to individual respiratory capacities during laparoscopic surgeries. Current
practice often employs fixed tidal volume (Vt) approaches, which may not effectively
account for variations in lung function among paediatric patients.
Consequently, this one-size-fits-all approach increases the risk of
intraoperative lung injury, morphological alterations, and postoperative
pulmonary complications (PPCs). Addressing this gap in ventilation management
is crucial to optimize perioperative care and improve outcomes in paediatric
laparoscopic surgery.
Novelty: This research lies in its
personalized mechanical ventilation strategy, utilizing gold standard
spirometry to individualize tidal volume for each patient. This approach
contrasts with current practices and could significantly contribute to our understanding
of mechanical ventilation in pediatric laparoscopic surgery, potentially
improving outcomes.
Methods: The study will randomize pediatric
patients into two groups: one receiving low tidal volume ventilation (Group L)
and the other guided by preoperative spirometry (Group S). Anesthesia
maintenance will utilize the Mindray Wato Ex55 ventilator,
with double-blinding to ensure unbiased assessment.
Objectives include evaluating the impact of
spirometry-measured tidal volume on intra-operative lung atelectasis,
postoperative FEV1/FVC, Modified Aldrete’s score, and pulmonary complications.
Expected outcomes: Include improvements in intra-operative lung
function, postoperative respiratory parameters, recovery scores, and a
reduction in pulmonary complications.
In summary, this research offers a tailored
approach to mechanical ventilation in pediatric laparoscopic surgery, aiming to
improve perioperative care and outcomes through innovative use of preoperative
spirometry-measured tidal volume. |