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CTRI Number  CTRI/2024/07/071375 [Registered on: 26/07/2024] Trial Registered Prospectively
Last Modified On: 25/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Randomized Trial Comparison of Sustained Hyperinflation and Sequential lateral postural maneuver as Lung Recruitment Strategies in Mechanically ventilated Critically ill Cirrhotic patients 
Scientific Title of Study   Comparison of Sequential lateral postural maneuver and Sustained hyperinflation maneuver as lung recruitment strategy in critically ill cirrhotic patients on mechanical ventilation A Randomised controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sahithi Latha Ronanki 
Designation  Senior Resident 
Affiliation  Institute Of Liver And Biliary Sciences 
Address  Department Of Anaesthesia and Critical care,Institute Of Liver And Biliary Sciences,Vasant Kunj,New Delhi

New Delhi
DELHI
110070
India 
Phone  6281714682  
Fax    
Email  dr.sahithironanki@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Deepak K Tempe 
Designation  Head of The Department,Anaestheisa and Critical Care 
Affiliation  Institute Of Liver And Biliary Sciences 
Address  Room Number 3338, Department Of Anaestheisa And Critical Care, Institute Of Liver And Biliary Sciences,Vasant Kunj VASANT KUNJ,NEW DELHI

New Delhi
DELHI
110070
India 
Phone  9718599401  
Fax    
Email  tempedeepak@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Sahithi Latha Ronanki 
Designation  Senior Resident 
Affiliation  Institute Of Liver And Biliary Sciences 
Address  Department Of Anaesthesia and Critical care,Institute Of Liver And Biliary Sciences,Vasant Kunj,New Delhi

New Delhi
DELHI
110070
India 
Phone  6281714682  
Fax    
Email  dr.sahithironanki@gmail.com  
 
Source of Monetary or Material Support  
Institute Of Liver And Biliary Sciences,Sector D1,Vasant Kunj,New Delhi,India,110070 
 
Primary Sponsor  
Name  Institute Of Liver And Biliary Sciences Vasnt KunjNew Delhi 
Address  Institute Of Liver and Biliary Sciences,Sector D1, Vasant Kunj New Delhi,India 110070 
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 Sahithi Latha Ronanki  Institute Of Liver And BIliary Sciences,Pocket D1 ,Vasant Kunj  Seminar Room,Department Of Anaesthesia,Institute Of liver And Biliary Sciences,Vasnt Kunj,New Delhi,110070
New Delhi
DELHI 		 6281714682

dr.sahithironanki@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,Institute Of Liver And Biliary Sciences,Sector D1,Vasnt Kunj,New Delhi,110070  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J80||Acute respiratory distress syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  SEQUENTIAL LATERAL POSITIONING:  Patients would be studied in five body positions in sequential order, each maintained during 30 min: • Supine-1 (S1), which served as the baseline condition • Lateral-1 at 30 degree • Supine-2 (after first lateral position) • Lateral-2 (the contralateral lung was positioned up at 30 degree) • Supine-3 (after second lateral position). • At the end of each 150 minutes, arterial blood gas samples, hemodynamics, pulmonary mechanics, and lung ultrasound images would be noted. 
Intervention  SUSTAINED HYPERINFLATION TECHNIQUE:   Patients who are orally intubated and mechanically ventilated,sedated with a Propofol–fentanyl combination and paralyzed with Atracurium. Ventilator Settings: Volume control mode. SUSTAINED HYPERINFLATION TECHNIQUE: • Patients would be kept in a supine position with the head of the bed elevated to 30 degree.FIO2 adjusted to SpO2 92–97% • Tidal volume ≤6 mL/kg predicted body weight, • Plateau pressure of ≤28 cmH2O • Driving pressure ≤15 cmH2O • Respiratory rate 20–30 breaths/min (adjusted to pH 7.20–7.40) • Inspiratory– expiratory ratio of 1:2 • A sustained inflation Recruitment manuever to be performed using 40 cmH2O PEEP sustained for 30 s. (Airway pressure would be increased from 10 to 40 at the rate of 5 cm H2o for every 2 seconds and would be maintained for 30 sec.) • Similarly, afterwards airway pressure would be decreased from 40 to 10 at a rate of 5 cm H2o for every 3 seconds. 10 • Afterwards basal ventilation to be resumed.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All chronic liver disease patients and ACLF patients.
• Body mass index ≤ 35 kg/m2
• Hypoxemic patients with PaO2/FiO2 ratio measured by blood gas analysis of 150 to
200. 
 
ExclusionCriteria 
Details  • Pregnancy
• COPD
• Increased intracranial pressure.
• Unstable spine or pelvic fractures
• Patients with Pacemaker and Automatic implantable cardio-defibrillator
• Hemodynamic instability defined as persistent mean arterial pressure lower than 60
mm Hg despite adequate fluid resuscitation and two vasopressors or increase of
vasopressor dose by 30% in the previous 6 hours.
• Patients with large pleural effusions and Intercoastal drains.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
:To compare the physiological effects of the two recruitment
maneuvers on the oxygenation (PaO2/FiO2 ratio) after 30 minutes 		 30 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
To study the effect of recruitment maneuver on
▪ Pulmonary mechanics – Compliance, Peak airway pressure, plateau
pressure,Paco2,Spo2.
▪ Haemodynamics – Systolic Blood Pressure, Diastolic blood
pressure,Mean arterial pressure
▪ USG Scores of Lung – at baseline and 30 minutes after recruitment.
➢ Proportion of patients whose P/F ration improved above 300
 		 30 minutes 
 
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/ Phase 3 
Date of First Enrollment (India)   05/08/2024 
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   The dynamic process of reopening previously collapsed lung units through an intended transitory increase in trans pulmonary pressure is referred to as recruitment. • Recruitment maneuvers are methods for increasing the oxygenation by maintaining and reopening non-aerated areas of the lungs. 7 • Useful in 1. Improving gas exchange 2. Improving respiratory compliance • Patients receiving positive pressure ventilation are prone to develop atelectasis and need periodic recruitment. • In cirrhotic patients on ventilator, following are the reasons for developing atelectasis. • Ascites that contributes to the loss of aeration in caudal and dependent lung segments leading to atelectasis and airway closure. • Thoracic compliance is decreased by respiratory anomalies including hepatic hydrothorax and pleural effusions (chest wall edema). • A relative immunocompromised status combined with an overactive inflammatory response increases the risk of pneumonia and acute lung damage. 
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