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CTRI Number  CTRI/2022/11/047212 [Registered on: 11/11/2022] Trial Registered Prospectively
Last Modified On: 27/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Ventilation strategy in patients undergoing one lung ventilation 
Scientific Title of Study   Impact of individualised PEEP in patients undergoing one lung ventilation: a Randomised control trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pratishtha Yadav 
Designation  Senior resident (DM student) 
Affiliation  Dr. BR Ambedkar Institute Rotary Cancer Hospital,AIIMS 
Address  Dept of onco anaesthesia and palliative medicine Dr. BR Ambedkar Institute Rotary Cancer Hospital AIIMS Campus, Ansari Nagar

East
DELHI
110016
India 
Phone    
Fax    
Email  pratishthayadav88@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Vinod Kumar 
Designation  Additional professor 
Affiliation  Dr. BR Ambedkar Institute Rotary Cancer Hospital AIIMS 
Address  dept of onco anaesthesia and palliative medicine Dr. BR Ambedkar Institute Rotary Cancer Hospital AIIMS Campus, Ansari Nagar

East
DELHI
110016
India 
Phone    
Fax    
Email  vkchanpadia@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Pratishtha Yadav 
Designation  Senior resident (DM student) 
Affiliation  Dr. BR Ambedkar Institute Rotary Cancer Hospital AIIMS 
Address  dept of onco anaesthesia and palliative medicine Dr. BR Ambedkar Institute Rotary Cancer Hospital AIIMS Campus, Ansari Nagar

East
DELHI
110016
India 
Phone    
Fax    
Email  pratishthayadav88@gmail.com  
 
Source of Monetary or Material Support  
All India Institute Of Medical Sciences, Delhi 
 
Primary Sponsor  
Name  All India Institute Of Medical Sciences delhi 
Address  Ansari Nagar Sri Aurobindo marg Delhi 110029 
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 
Pratishtha Yadav  All India Institute Of Medical Sciences  dept of onco anaesthesia and palliative medicine Dr. BR Ambedkar Institute Rotary Cancer Hospital AIIMS Campus, Ansari Nagar
East
DELHI 
7011553571

pratishthayadav88@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C159||Malignant neoplasm of esophagus, unspecified, (2) ICD-10 Condition: C343||Malignant neoplasm of lower lobe,bronchus or lung, (3) ICD-10 Condition: C155||Malignant neoplasm of lower thirdof esophagus, (4) ICD-10 Condition: C340||Malignant neoplasm of main bronchus, (5) ICD-10 Condition: C342||Malignant neoplasm of middle lobe,bronchus or lung, (6) ICD-10 Condition: C154||Malignant neoplasm of middle thirdof esophagus, (7) ICD-10 Condition: C348||Malignant neoplasm of overlappingsites of bronchus and lung, (8) ICD-10 Condition: C158||Malignant neoplasm of overlappingsites of esophagus, (9) ICD-10 Condition: C413||Malignant neoplasm of ribs, sternum and clavicle, (10) ICD-10 Condition: C349||Malignant neoplasm of unspecifiedpart of bronchus or lung, (11) ICD-10 Condition: C341||Malignant neoplasm of upper lobe,bronchus or lung, (12) ICD-10 Condition: C153||Malignant neoplasm of upper thirdof esophagus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized PEEP will be applied that is the one corresponding maximum lung compliance  In this group, once the OLV has started and the patient is haemodynamically stable HR 60/min and MAP within 20% of the baseline, PPV 13% the alveolar recruitment maneuver will be applied to ventilated lung followed by PEEP titration trial. Same process will be repeated once patient is shifted from OLV to Two-lung ventilation. duration of therapy will be intraoperative period only. 
Comparator Agent  PEEP of 5cm H2O will be applied  Patient will be ventilated with the ventilatory settings described above with a PEEP of 5cm H2O till the end of surgery. duration of therapy will be till intraoperative period only.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients undergoing elective thoracotomy surgery with OLV lobectomy metastatectomy esophagectomy chest wall resection surgery
ASA Physical Status I, II and III  
 
ExclusionCriteria 
Details  Patients who do not give consent for the study
Patients with Body Mass Index (BMI) < 18.5 kg/m2 and > 35 kg/m2
Patients with moderate to severe derangements in Pulmonary Function Tests
Moderate to severe ARDS
Presence of bullae, pneumothorax in Chest Xray or CT scan
Severe COPD patients
COPD patients requiring oxygen therapy or CPAP
Previous lung resection surgery
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To study the impact of alveolar recruitment followed by individualised PEEP on the oxygenation during and after OLV  24 hours from surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Change in driving pressure, plateau pressure, peak pressure at selected time points  24 hours from surgery 
Change in pH, PaO2, PCO2, lactate at selected time points  T1 5 minutes after induction, supine, TLV
T2 lateral decubitus, OLV 30 minutes after recruitment and PEEP titration
T3 at the end of OLV TLV supine, after recruitment and re-PEEP titration
 
Change in haemodynamic parameters PPV MAP HR SpO2  T1 5 minutes after induction supine TLV
T2 lateral decubitus, OLV 30 minutes after recruitment and PEEP titration
T3 at the end of OLV TLV supine after recruitment and re-PEEP titration
 
Post-operative pulmonary complications  30 days from surgery 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/11/2022 
Date of Study Completion (India) 01/04/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [pratishthayadav88@gmail.com].

  6. For how long will this data be available start date provided 28-12-2022 and end date provided 28-12-2027?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

One lung ventilation (OLV) is used to ventilate one lung and leaving the other lung deflated and collapsed. OLV is required in thoracic surgery, cardiac surgery, and oesophagus surgery. OLV in lateral decubitus position has a significant impact on lung mechanics and oxygenation. Incidence of acute lung injury (ALI) after OLV is 2 %, with a mortality of 54% in patients who developed ALI post-OLV.Incidence of post-operative pulmonary complications is higher with OLV as compared to other surgeries 2. Lung protective ventilation recommends using low tidal volume with higher positive end-expiratory pressure (PEEP). Very low PEEP can lead to cyclical collapse and reaeration, whereas high PEEP can lead to over distention. A single value of PEEP may not be appropriate for every patient.3 Inter-individual variability in BMI, lung characteristics, chest wall dimensions,  emphasises the need to individualise PEEP for every patient. 

There is no general consensus on how to set PEEP intraoperatively. Too low a PEEP can lead to atelectasis. Lung heterogeneity due to atelectasis eventually raises driving pressure (DP)4,5 . Unsafe ventilatory settings is one of the most important modifiable risk factor to prevent ALI due to OLV. There are several methods to identify ideal PEEP like oxygenation, best compliance, pressure - volume (P-V) curve, stress index, lung ultrasound, etc. Several retrospective studies have suggested a close association of PEEP with lung compliance and driving pressure. DP is defined as tidal volume divided by compliance or plateau pressure minus PEEP. The concept of DP was first studied in ARDS patients and was found to be strongly associated with patient outcome. If application of PEEP leads to lung recruitment, DP will decrease and SpO2 will increase. On the other hand excess PEEP can lead to lung overdistention, fall in DP and Spo2. Thus PEEP with maximum DP can be considered ideal for the given patient. Several studies have demonstrated improved oxygenation with use of individualised PEEP. But the data was restricted till the end of the surgery only. Inadequate lung recruitment while shifting the patient from OLV to TLV and loss of PEEP during the weaning phase at the end of the surgery can have a negative impact on the outcome as well. 

 
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