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
|
|
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
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [pratishthayadav88@gmail.com].
- 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.
- 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.1 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. |