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 |
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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
|
|
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
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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.
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|
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
|
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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. |