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CTRI Number  CTRI/2025/03/083178 [Registered on: 24/03/2025] Trial Registered Prospectively
Last Modified On: 20/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Ultrasound guided lung recruitment to improve lung health in infants undergoing anorectal surgery under general anaesthesia. 
Scientific Title of Study   A randomised controlled study for effectiveness of ultrasound guided regular alveolar recruitment upon pre-extubation lung atelectasis in pediatric population below 2 years of age, undergoing posterior sagittal anorectoplasty surgery. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ira Bhardwaj 
Designation  MD Anaesthesiology Junior Resident 
Affiliation  Sawai Man Singh Medical College and Hospital, Jaipur  
Address  Department of Anaesthesiology 2nd floor dhanwantari building sms medical college jaipur Jaipur RAJASTHAN 302004 India

Jaipur
RAJASTHAN
302004
India 
Phone  8910930244  
Fax    
Email  irabhardwaj1313@icloud.com  
 
Details of Contact Person
Scientific Query  
Name  Neelam Dogra 
Designation  Senior Professor  
Affiliation  Sawai Man Singh Medical College and Hospital, Jaipur  
Address  Department of Anaesthesiology 2nd floor dhanwantari building sms medical college jaipur Jaipur RAJASTHAN 302004 India

Jaipur
RAJASTHAN
302004
India 
Phone  9928709289  
Fax    
Email  neelam_dogra24@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Neelam Dogra 
Designation  Senior Professor 
Affiliation  Sawai Man Singh Medical College and Hospital, Jaipur  
Address  Department of Anaesthesiology 2nd floor dhanwantari building sms medical college jaipur Jaipur RAJASTHAN 302004 India

Jaipur
RAJASTHAN
302004
India 
Phone  9928709289  
Fax    
Email  neelam_dogra24@yahoo.com  
 
Source of Monetary or Material Support  
department of anaesthesiology, SMS medical college and attached hospitals, jaipur, Rajasthan, India. Pin- 302001 
 
Primary Sponsor  
Name  SMS medical college jaipur 
Address  department of anaesthesia 2nd floor dhanwantari building sms medical college jaipur, Rajasthan, India. Pin- 302001 
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 
Dr Ira Bhardwaj   sms medical college and hospital  department of anaesthesia, HOD office, 2nd floor dhanwantari building Pin 302001 Jaipur RAJASTHAN
Jaipur
RAJASTHAN 		 8910930244

irabhardwaj1313@icloud.com  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
office of ethic comittee sms medical college and attached hospital, jaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Q423||Congenital absence, atresia and stenosis of anus without fistula,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Comparing the hourly regular lung recruitment manoeuvre along with the baseline ultrasound guided lung recruitment manoeuvre in group A, with the single baseline ultrasound guided lung recruitment manoeuvre in group B.  After induction, baseline supine lung ultrasound will be done and ultrasound guided lung recruitment will be done in both the groups to restore FRC, where a stepwise increase in airway pressure by 5 cmH2O increments with 0.4 inspired oxygen fraction will be applied manually until no collapsed lung areas are visible on the ultrasound. (Maximum airway pressure limited to 40 cmH2O). Patient will be positioned prone. During mechanical ventilation, the regular recruitment group (Group A) will receive ultrasound guided alveolar recruitment once every 60 mins, whereas the control group (Group B) will not receive the hourly alveolar recruitment. At the end of the surgery, lung ultrasound will be done in both the groups and consolidation and B line scores will again be noted. 
Comparator Agent  the standard practice of a single alveolar recruitment maneuver performed at the start of surgery.  After the induction of patient in general anaesthesia, ultrasound guided lung recruitment is performed in BOTH GROUPS to restore FRC where a stepwise increase in airway pressure by 5 cmH2O increments with 0.4 inspired oxygen fraction applied manually until no collapsed lung areas are visible on ultrasound. Maximum airway pressure is limited to 40 cmH20. 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  24.00 Month(s)
Gender  Both 
Details  1. Consenting parents or guardians.
2. patient posted for elective Posterior Sagittal Anorectoplasty.
3. surgery duration more than 1 hour.
4. ASA grade 1 and 2. 
 
ExclusionCriteria 
Details  1. Patient who is a part of any other study.
2. Non-consenting parent/guardian.
3. Patients with previous thoracic surgery.
4. History of lung disease, airway anomalies, or airway infection 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Mean consolidation score of various lung regions.
2. Mean B-line score of various lung regions. 		 1. baseline supine scan- after induction of general anaesthesia. (0 min)
2. baseline prone scan - after prone positioning of the patient. (5min)
3. At 1hr, 2hr till surgery is complete.
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Mean number of episodes of Desaturation (SpO2 less than 95%) during mechanical ventilation, emergence from general anaesthesia, and the postoperative period (upto 12 hours).
2. Mean episodes of hypotension during alveolar recruitment.

 		 1. Heart rate, SBP, DBP and SpO2 noted at baseline (Pre operative), 0 min (baseline alveolar recruitment), 10 min, 20 min, 30 min, 40 min, 50 min, 60 min ( alveolar recruitment manoeuvre in experimental group), 70 min, 80 min,…after extubation, every 15 mins in PACU. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 
Date of First Enrollment (India)   15/04/2025 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   Atelectasis is a common complication in paediatric patients undergoing general anaesthesia, particularly in those under three years old, due to their reduced functional residual capacity and increased airway collapsibility. This randomised controlled interventional study aims to evaluate the effectiveness of regular alveolar recruitment using ultrasound in preventing intraoperative lung atelectasis in paediatric patients undergoing PSARP surgery in the prone position.
 The study will compare two groups, one receiving a single alveolar recruitment manoeuvre at the start of the surgery and the other undergoing hourly alveolar recruitment. Lung ultrasound will be used to assess lung consolidation and B- line scores before extubation, The primary objective is to determine whether alveolar recruitment significantly reduces the incidence of pre- extubation atelectasis.
The null hypothesis states that there is no significant difference in occurrence of atelectasis between the two groups, and the alternative hypothesis proposes that regular recruitment reduces atelectasis. The study’s findings could provide valuable insights into optimizing intraoperative ventilation strategies to improve respiratory outcomes in paediatric anaesthesia.
 
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