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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  Nil

  6. 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.

  7. 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.

 
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