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CTRI Number  CTRI/2024/01/061175 [Registered on: 08/01/2024] Trial Registered Prospectively
Last Modified On: 05/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [comparison of two routinely practiced treatment protocols]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative study between two ventilatory methods on the changes in air distribution in different regions of the lung in patients with severe respiratory failure 
Scientific Title of Study   Comparison of Optimal PEEP ventilation vs Prone position ventilation on changes in Regional Lung Ventilation in Patients with Acute Respiratory Distress Syndrome - A Randomized Clinical 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  ALLAN BENHUR C I 
Designation  Senior Resident 
Affiliation  JIPMER 
Address  Department of Anaesthesiology and Critical care, JIPMER, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  8123621619  
Fax    
Email  benhurallan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR PANKAJ KUNDRA 
Designation  PROFESSOR 
Affiliation  JIPMER 
Address  Department of Anaesthesiology and Critical care, JIPMER, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9367602030  
Fax    
Email  p_kundra@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  ALLAN BENHUR C I 
Designation  Senior Resident 
Affiliation  JIPMER 
Address  Department of Anaesthesiology and Critical care, JIPMER, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  8123621619  
Fax    
Email  benhurallan@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry 605006. 
 
Primary Sponsor  
Name  JIPMER 
Address  JIPMER, Puducherry, 605006 
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 Allan Benhur C I  JIPMER  WARD NO 21 - Critical Care Unit, Department of Anaesthesiology and Critical Care.
Pondicherry
PONDICHERRY 
8123621619

benhurallan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Interventional Studies  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J960||Acute respiratory failure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Optimal PEEP ventilation  Patient will be sedated with IV Fentanyl and or Propofol and or Midazolam, according to hemodynamic status, and sedation will be titrated so that patient is not verbally responsive and has loss of eyelash reflex. Following achievement of adequate sedation, patient will be administered muscle relaxant, to achieve paralysis, as PEEP titration requires complete passive ventilation without patients’ respiratory efforts.Ventilator will be set to AC VCV mode, TV of 6ml/kg of ideal body weight, Flow of 40l per min, Initial PEEP will be empirically set according to ARDSnet protocol, Pmax is set to 45 cm H2O, following which PEEP will be incrementally titrated 2cms every 5 mins, at each PEEP set, following parameters will be recorded.Ventilator will be set to AC VCV mode, TV of 6ml/kg of ideal body weight, Flow of 40l per min, Initial PEEP will be empirically set according to ARDSnet protocol, Pmax is set to 45 cm H2O, following which PEEP will be incrementally titrated 2cms every 5 mins, at each PEEP set, following parameters will be recorded.Ventilator will be set to AC VCV mode, TV of 6ml/kg of ideal body weight, Flow of 40l per min, Initial PEEP will be empirically set according to ARDSnet protocol, Pmax is set to 45 cm H2O, following which PEEP will be incrementally titrated 2cms every 5 mins, at each PEEP set, following parameters will be recorded. HR, BP, FIO2, SPO2, Spo2/Fio2, Pplat, Ppeak, Driving pressure(Pplat – PEEP),Static compliance (TV/ Driving Pressure). Optimal PEEP is decided as the lowest PEEP which achieves maximum compliance and SPO2/FIO2. After optimal PEEP is identified, patient will be ventilated on the particular PEEP, and returned to previous ventilation mode, driving pressure is adjusted less than or equal to 15cm H2O to give a TV less than or equal to 6-8 ml/kg IBW, if plateau pressure more than 30 cm H2O driving pressure is adjusted so that TV is 4-6 ml per kg IBW, if required respiratory rate is increased up to 30 breaths per min to maintain same minute volume.  
Comparator Agent  Prone Position ventilation  Routine prone ventilation precautions will be followed. Endotracheal tube position is confirmed and well secured, ventilatory settings will be optimized, FiO2 is set to 100%, ETT and oral cavity suctioned, unnecessary lines or either removed or capped, adequate sedation is ensured, pulse oximeter probe is placed on limb which is not being turned under patient. While turning minimum 2 staff in each side of bed and doctor at the head end to manage Endotracheal tube are stationed, adequate padding of the eyes, head ring, bolsters under chest, pelvis, and pillow under shin are kept ready, and patient is turned slowly toward ventilator until in prone position. Endotracheal tube, lines and tubes are rechecked, arms are positioned in modified swimmers crawl. Patients will be ventilated as per standard guidelines for ARDS management, and PEEP selection is done according to Fio2 requirement to achieve target Spo2 by the treating intensivist according to ARDSnet protocol.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Age :18 - 75 years
2. Diagnosis of ARDS according to Berlin’s criteria.
a.Symptom begin within 1 week of insult, or new/worsening symptoms in last 1 week.
b.Bilateral opacities on chest imaging
c.PaO2/FiO2 < 300 while on PEEP > 5 cm H2O
d.Not fully attributed to cardiac failure and / or volume overload
3.PaO2/FiO2 <200
4.Anticipated duration of mechanical ventilation >48 hours
 
 
ExclusionCriteria 
Details  1.Contraindication for prone positioning
2.Hemodynamic instability – Requirement of two or more vasopressor infusions to maintain target MAP.
3.Already receiving prone ventilation
4.Pregnancy
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the changes in regional lung ventilation (TIV dorsal/TIVtotal) with optimal PEEP ventilation and Prone ventilation in patients with ARDS  1.Before intervention,
2.10 mins after intervention,
3. 6 hours after intervention
4. 12 hours after intervention.
 
 
Secondary Outcome  
Outcome  TimePoints 
1)To compare the Driving Pressure between the groups.
2)To compare the changes in oxygenation from baseline (paO2/FiO2) between the groups.
3)To compare the changes in pCO2 level from baseline between the groups.
4)To compare the mean airway pressure between the groups.
 
1.Before intervention,
2.10 mins after intervention,
3. 6 hours after intervention
4. 12 hours after intervention.
 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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 3 
Date of First Enrollment (India)   22/01/2024 
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="2"
Months="0"
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  

Mechanical ventilation is frequently required in patients with acute  respiratory failure, even though being life saving, positive pressure ventilation  has many   detrimental effects   like    adverse effects on hemodynamics and ventilator induced lung injury (VILI). Lung protective ventilation which includes avoiding high tidal volume, high inspiratory pressures along with optimal positive end expiratory pressure (PEEP) selection is being followed to prevent VILI and improve oxygenation in patients with Acute Respiratory Distress Syndrome (ARDS). The optimal PEEP selection remains a difficult task even though a standardized approach to adjust PEEP is available in terms of PEEP/ FiO2 table as per ARDS network guidelines, and other PEEP titration methods guided by lung mechanics. These methods probably consider the global lung mechanics, and do not take into consideration the regional lung ventilation with varying PEEP levels. Prone ventilation is another ventilatory strategy in ARDS, where it is used as rescue therapy in severe ARDS, by which it helps in homogenisation of ventral- dorsal transpulmonary pressure difference, reduces dorsal lung compression and improves oxygenation. Moreover the effect on regional ventilation in use of optimal PEEP ventilation strategy in supine position when compared to prone ventilation is not well explored. 

PEEP selection and titration are usually performed by assessing lung mechanics, and variables of lung mechanics are assessed considering the lung as a single unit, hence, the effects on regional lung ventilation are not apparent. Electrical impedance tomography is a non invasive, non-radioactive, bedside imaging tool, providing functional images with a high temporal resolution. Images obtained are also dynamic, allowing us to follow the response of the lungs to any therapeutic intervention. Regional overdistension and alveolar collapse can be visualized using EIT. Hence, it can be used to assess the status of regional lung ventilation with optimal PEEP ventilation as well as prone ventilation. As the regional lung ventilation in terms of regional overdistension and alveolar collapse can be visualized dynamically breath by breath using EIT, the effect of Optimal PEEP ventilation after PEEP titration and the effect of prone position ventilation on regional ventilation can be assessed in better certainty with EIT. By ventilating patients with Optimal PEEP, as identified by PEEP titration method, the regional lung ventilation achieved may be comparable to regional lung ventilation achieved by prone ventilation in patients with ARDS.

If comparable results are found, Optimal PEEP ventilation with PEEP titration can be used instead of Prone ventilation strategy.

Study Hypothesis : Regional lung ventilation (TIV dorsal /TIV total) between Optimal PEEP ventilation method and Prone position ventilation are comparable.
 
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