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CTRI Number  CTRI/2017/09/009729 [Registered on: 12/09/2017] Trial Registered Retrospectively
Last Modified On: 08/09/2017
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective Observational Study 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Comparison of effect of two methods of Alveolar Recruitment Maneuvers in improving oxygenation in patients with Acute Respiratory Distress Syndrome. 
Scientific Title of Study   COMPARISON OF VOLUME CONTROL VERSUS PRESSURE CONTROL STEPWISE ALVEOLAR RECRUITMENT MANEUVER IN ACUTE RESPIRATORY DISTRESS SYNDROME – A PROSPECTIVE OBSERVATIONAL STUDY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
IEC 320/2016  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Miss Ann Mary Jose 
Designation  BSc. Respiratory Therapist 
Affiliation  School of Allied Health Sciences, Manipal University 
Address  Department of Respiratory Therapy School of Allied Health Sciences, Manipal University Manipal, Udupi Karnataka - 576104

Udupi
KARNATAKA
576104
India 
Phone  8971749461  
Fax    
Email  jann1891@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Ramesh Unnikrishnan 
Designation  Assistant Professor 
Affiliation  School of Allied Health Sciences, Manipal University 
Address  Head of Department of Respiratory Therapy SOAHS, Manipal University Manipal, Udupi Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9900404492  
Fax    
Email  ramesh.unnikrishnan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mr Ramesh Unnikrishnan 
Designation  Assistant Professor 
Affiliation  School of Allied Health Sciences, Manipal University 
Address  Head of Department of Respiratory Therapy SOAHS, Manipal University Manipal, Udupi Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9900404492  
Fax    
Email  ramesh.unnikrishnan@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College and Hospital Manipal, Udupi Karnata 576104 
 
Primary Sponsor  
Name  KMC Hospital Manipal 
Address  KMC Hospital Manipal University Manipal Udupi Karnataka 576104 
Type of Sponsor  Private 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 
Miss Ann Mary Jose  Kasturba Medical College and Hospital, Manipal  Department of Respiratory Therapy School of Allied Health Sciences, Manipal Udupi Karnataka 576104
Udupi
KARNATAKA 		 8971749461

jann1891@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Hospital Manipal, Institutional Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ARDS patients,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All adult patients with moderate or severe stage of ARDS who requires invasive mechanical ventilation. 
 
ExclusionCriteria 
Details  1. Patients age < 18 years
2. Pregnant women
3. Neurosurgical patients
4. Thoracic surgery patients
5. Patients with bronchopulmonary fistula
6. Patients with chest trauma (including lung contusion, hemothorax, or pneumothorax)
History of severe chronic obstructive pulmonary disease (had bullae or blebs visible on chest radiograph)
7. Patients who are haemodynamically unstable.
Haemodynamic instability as defined by an increase in heart rate by more than 20 beats/minute from baseline, bradycardia < 50 beats per minute; drop in systolic blood pressure exceeding 20 mm Hg from the baseline.
Desaturation (decrease by > 5% SpO2) from baseline on pulse oximetry.



 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Compare the improvement in oxygenation (increase in PaO2/FiO2 post application of recruitment manoeuvre) with pressure control and volume control stepwise recruitment maneuvers in Acute Respiratory Distress Syndrome.  30 minutes after application of recruitment maneuver 
 
Secondary Outcome  
Outcome  TimePoints 
Complications that can occur during application of RM compared among PCV – RM group and VCV – RM group  COMPLICATIONS: WITHIN 1 HOUR
 
 
Target Sample Size   Total Sample Size="29"
Sample Size from India="29" 
Final Enrollment numbers achieved (Total)= "29"
Final Enrollment numbers achieved (India)="29" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/07/2016 
Date of Study Completion (India) 31/01/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

In our study, an effort was made to elucidate the clinical impact of stepwise alveolar recruitment maneuvers (PC – RM and VC – RM)in patients with moderate to severe ARDS classified by Berlin’s. Our results suggest that there is no significant difference between the two modes of recruitment maneuvers in improving oxygenation, occurrence of complications, hospital days, ventilator days and survival rate.

In total, 29 patients were enrolled over a period of 7 months and evaluated during recruitment maneuver. A total number of 16 (59%) subjects received PC – RM and 11 (41%) subjects received VC – RM. In the demographic and diagnostic variables age and the SOFA score was significantly different between PC – RM and VC – RM group.

The change in PaO2/FiO2 ratio from baseline to 30 minutes post recruitment showed statistically significant improvement in both the groups. In our study, post recruitment maneuver, no complications occurred. We find no difference in mortality between the 2 modes of recruitment. Possible factors that may explain this finding is that similar baseline characteristics such as severity of ARDS, and APACHE II score on the day of ICU admission.




 
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