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CTRI Number  CTRI/2024/01/061058 [Registered on: 02/01/2024] Trial Registered Prospectively
Last Modified On: 30/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Effect of the positioning with soft tissue manipulation on oxygen saturation and haemodynamic parameters in mechanically ventilated paediatric patients 
Scientific Title of Study   Effect of right and left lateral position combined with soft tissue manipulation on oxygen saturation and hemodynamic parameters in mechanically ventilated pediatric patients. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nishant 
Designation  PG Student 
Affiliation  College of Physiotherapy, Pt. B. D. Sharma University of Health Sciences, PGIMS, Rohtak 
Address  College Of Physiotherapy, room no. 4, E- block, Pt. B. D. Sharma University of Health Sciences, PGIMS, Rohtak
College Of Physiotherapy, room no. 4, E- block, Pt. B. D. Sharma University of Health Sciences, PGIMS, Rohtak
Rohtak
HARYANA
124001
India 
Phone  9254643492  
Fax    
Email  nishantdalal0009@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gitanjali Sikka 
Designation  Assistant Professor 
Affiliation  College of Physiotherapy, Pt. B. D. Sharma University of Health Sciences, PGIMS, Rohtak 
Address  College Of Physiotherapy, room no. 4, E- block, Pt. B. D. Sharma University of Health Sciences, PGIMS, Rohtak
College Of Physiotherapy, room no. 4, E- block, Pt. B. D. Sharma University of Health Sciences, PGIMS, Rohtak
Rohtak
HARYANA
124001
India 
Phone  7027192620  
Fax    
Email  gsikka.cphy@uhsr.ac.in  
 
Details of Contact Person
Public Query
 
Name  Nishant 
Designation  PG Student 
Affiliation  College of Physiotherapy, Pt. B. D. Sharma University of Health Sciences, PGIMS, Rohtak 
Address  College Of Physiotherapy, room no. 4, E- block, Pt. B. D. Sharma University of Health Sciences, PGIMS, Rohtak
College Of Physiotherapy, room no. 4, E- block, Pt. B. D. Sharma University of Health Sciences, PGIMS, Rohtak
Rohtak
HARYANA
124001
India 
Phone  9254643492  
Fax    
Email  nishantdalal0009@gmail.com  
 
Source of Monetary or Material Support  
College of Physiotherapy, room no. 4, E- block, Pt. B. D. Sharma University of Health Sciences, PGIMS, Rohtak 
 
Primary Sponsor  
Name  Nishant 
Address  College of Physiotherapy, room no. 4, E- block, Pt. B. D. Sharma University of Health Sciences, PGIMS, Rohtak 
Type of Sponsor  Other [Self] 
 
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 Kundan Mittal  Neonatal ICU and Paediatric ICU   Pt. B. D. Sharma, PGIMS, Rohtak
Rohtak
HARYANA 
9416514111

kundanmittal@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical Research Ethics Committee Pt. B. D. Sharma Post Graduate Institute of Medical Sciences, UHS, Rohtak  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J969||Respiratory failure, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group 1- soft tissue manipulation followed by left lateral position  Soft tissue manipulation for 10 minutes and left lateral position for 1 hour 
Comparator Agent  Group 2- soft tissue manipulation followed by right lateral position   Soft tissue manipulation for 10 minutes and right lateral position for 1 hour 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  59.00 Month(s)
Gender  Both 
Details  1 Mechanically ventilated pediatric patients
2 Pediatric patients from the age group 0-59 months
3 Pediatric patients with respiratory failure
4 Pediatric patient with neurological disorders
5 Subjects with known pulmonary pathologies 
 
ExclusionCriteria 
Details  1 Fever
2 Hypertension or hypotension
3 Subjects with known cardiac disorders
4 Hemodynamic unstability 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
• Oxygen saturation
• SF ratio
• Heart rate
• Blood pressure
• Respiratory rate  
After 15 minutes, after 30 minutes, after 45 minutes and after 60 minutes of intervention  
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   08/01/2024 
Date of Study Completion (India) 06/02/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 is a crossover study. Aim of the study is to see the impact
of the left and right lateral position combined with soft tissue manipulation on oxygen
saturation, SF ratio, heart rate, blood pressure and respiratory rate.
A total of 60 participants will be randomly allocated using a computer-generated
randomization list to receive either of the two intervention protocols. Each participant will
receive both interventions with a washout interval of 2 hours between each intervention.
PRE-intervention readings of various outcome measures including oxygen saturation, SF
ratio, heart rate, blood pressure and respiratory rate, of each participant will be taken
Suctioning will be done before positioning. A pillow will be placed between two legs and
the upper knee flexed. The upper limbs will be placed away from the body this prevents any
mechanical obstruction to the expansion of the lungs. The position of the endotracheal tube
will be checked and all other invasive lines will also be checked. The feeding via nasogastric
tube will be stopped 2 hours before position.
Soft tissue manipulation therapy will be performed for 5 minutes on the chest and 5 minutes
on the back. Soft tissue manipulation will consist of 4 steps, as follows: effleurage,
petrissage, kneading and stroking. Each step will be performed 10 times for 1 minute. Then
the patient will be laid in the position assigned to the group either left lateral or right lateral
for 1 hour.
Patients placed in either right lateral or left lateral position will be allowed to stabilize in the
first 15 minutes of the desired position and then after 15 minutes first reading of various
outcome measures will be collected and marked as (POST-1)
Further readings i.e. POST-2, POST-3 and POST-4 of Oxygen saturation, S/F ratio, heart
rate, respiratory rate and blood pressure will be measured every 15 minutes after the first 15
minutes of positioning.
After a washout interval of 2 hours soft tissue manipulation therapy is performed again as
done previously and the patient is laid in an alternate position for 1 hour.
During the intervention to ensure that the paediatric patient body temperature is not reduced,
the body temperature will be monitored every hour ICU monitor and the least painful
diagnostic or therapeutic procedure performed during the study. If the oxygen saturation in
any position will be less than 85%, the patient heart rate reaches about 200 beats per minute
or less than 100 beats per minute and/or the respiratory rate increases (more than 60 breaths
per minute), then the patient would be returned to the supine position and will be
immediately notified to the physician.
 
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