FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/12/098472 [Registered on: 04/12/2025] Trial Registered Prospectively
Last Modified On: 02/12/2025
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   A study to find out whether a guided breathing technique during anaesthesia can lower the risk of lung problems after surgery in teenagers 
Scientific Title of Study   Comparison of Spirometry-Guided Tidal Volume and Conventional Ventilation on Postoperative Respiratory Complications in Adolescents Undergoing General Anaesthesia: A Randomized Controlled Trail 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Devalla Deva Datta 
Designation  Junior Resident - Academic 
Affiliation  AIIMS BIBINAGAR 
Address  Dept. of Anaesthesiology, All Institute of Medical Sciences, Bibinagar Hyderabad Metropolitan Region

Hyderabad
TELANGANA
508126
India 
Phone  8639753939  
Fax    
Email  devadattadevalla@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  CH Rama Krishna Prasad 
Designation  Associate Professor 
Affiliation  AIIMS BIBINAGAR 
Address  Dept. of Anaesthesiology, All Institute of Medical Sciences, Bibinagar Hyderabad Metropolitan Region

Hyderabad
TELANGANA
508126
India 
Phone  9885718133  
Fax    
Email  ramakrishna.chikkala19@gmail.com  
 
Details of Contact Person
Public Query  
Name  CH Rama Krishna Prasad 
Designation  Associate Professor 
Affiliation  AIIMS BIBINAGAR 
Address  Dept. of Anaesthesiology, All Institute of Medical Sciences, Bibinagar Hyderabad Metropolitan Region

Hyderabad
TELANGANA
508126
India 
Phone  9885718133  
Fax    
Email  ramakrishna.chikkala19@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Bibinagar 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences, Bibinagar 
Address  All India Institute of Medical Sciences, Bibinagar, Hyderabad Metropolitan Region, Telangana 
Type of Sponsor  Government medical college 
 
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 
Devalla Deva Datta  All India Institute of Medical Sciences, Bibinagar  Room number G35 and G36, Operation Theater Complex, Department of Anaesthesiology, All India Institute of Medical Sciences, Bibinagar, Hyderabad Metropolitan Region
Hyderabad
TELANGANA 		 8639753939

devadattadevalla@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee(AIIMS BBN_IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Ventilation  Standard fixed Tidal Volume of 8-10ml/kg Body Weight. Routine ventilation as per institutional protocol 
Intervention  Spirometry-Guided Tidal Volume Ventilation  Use Spirometry values for Tidal Volume. Routine ventilation as per institutional protocol 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  19.00 Year(s)
Gender  Both 
Details  ASA 1 and 2 patients coming for GA lasting at least for 1 hour 
 
ExclusionCriteria 
Details  patients undergoing emergency surgeries, ASA grade more than 3, CDC growth charts BMI less than 5th percentile and more than 85th percentile, patients with any history of previous lung surgery, persistent hemodynamic instability, history of chronic/acute disease, patient with any neuromuscular disease 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Incidence and degree of atelectasis   Incidence and degree of atelectasis  
 
Secondary Outcome  
Outcome  TimePoints 
Post-anaesthesia recovery   Modified Aldrete score will be recorded at 1 hour and 6 hours in the PACU  
Postoperative respiratory complications   Defined and classified according to European Perioperative Clinical Outcome (EPCO) criteria, including: respiratory infection, respiratory failure, pleural effusion, atelectasis, bronchospasm, and aspiration pneumonitis. Assessments will be carried out at immediate postoperative period, 24 hours, 48 hours, and 72 hours 
 
Target Sample Size   Total Sample Size="102"
Sample Size from India="102" 
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   N/A 
Date of First Enrollment (India)   13/12/2025 
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="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 - NO
Brief Summary   This randomized controlled study investigates whether using spirometry-guided tidal volume can offer superior perioperative lung protection compared with conventional weight-based tidal volume ventilation in adolescents undergoing general anaesthesia. By individualizing ventilation based on each patient’s spirometric capacity, the study aims to reduce intraoperative atelectasis, improve lung aeration as assessed by Lung Ultrasound Score, and ultimately lower the incidence of postoperative respiratory complications, potentially establishing a more physiologically precise approach to adolescent perioperative ventilation. 
Close