| CTRI Number |
CTRI/2024/12/077976 [Registered on: 11/12/2024] Trial Registered Prospectively |
| Last Modified On: |
10/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Effect of different positive end expiratory pressures on lung strain in acute respiratory distress syndrome patients: randomized study |
|
Scientific Title of Study
|
Comparison of the lung strain with incremental positive end expiratory pressure (PEEP) and decremental positive end expiratory pressure (PEEP) recruitment maneuver in acute respiratory distress syndrome (ARDS) patients: prospective observational 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 |
EMANI ROJA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Nizams Institute of Medical Sciences |
| Address |
Department of Anesthesiology, Nizams Institute of medical sciences, panjagutta, Hyderabad.
Hyderabad
TELANGANA
500082
India |
| Phone |
7036004706 |
| Fax |
|
| Email |
roja14.emani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
NARMADA PADHY |
| Designation |
PROFESSOR |
| Affiliation |
Nizams Institute of Medical Sciences |
| Address |
Department of Anesthesiology, Nizams Institute of medical sciences, Panjagutta, Hyderabad.
Hyderabad
TELANGANA
500082
India |
| Phone |
7036004706 |
| Fax |
|
| Email |
narmadapadhy1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
EMANI ROJA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Nizams Institute of Medical Sciences |
| Address |
Department of anesthesiology, Nizams institute of medical sciences, panjagutta, Hyderabad.
Hyderabad
TELANGANA
500082
India |
| Phone |
7036004706 |
| Fax |
|
| Email |
roja14.emani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nizams Institute of medical sciences, Panjagutta, Hyderabad, Telangana, India -500082
|
|
|
Primary Sponsor
|
| Name |
Nizams Institute of Medical Sciences |
| Address |
Nizams Institute of Medical Sciences, Panjagutta, Hyderabad, Telangana, India-500082 |
| 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 |
| Emani Roja |
Nizams Institute of Medical Sciences |
Department of Anesthesiology and Intensive care, Nizams Institute of medical sciences, Panjagutta, Hyderabad.
Hyderabad
TELANGANA |
7036004706
roja14.emani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMS INSTITUTIONAL ETHICS COMMITTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J80||Acute respiratory distress syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group D |
Application of Decremental PEEP on day 1 and Incremental PEEP on day 2 |
| Intervention |
Group I |
Application of Incremental PEEP on day 1 and Decremental PEEP on day 2 |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
mechanically ventilated patients diagnosed with mild to moderate ARDS according to berlins definition |
|
| ExclusionCriteria |
| Details |
patient/attender refusal
pregnancy
large pleural effusion
pneumothorax
emphysema
broncho-pleural fistula
inter-costal draining tube in-situ
increased intracranial pressure
right heart failure with pulmonary hypertension
hemodynamic instability |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
changes in lung strain
changes in end expiratory lung volume (EELV) |
At each PEEP level on day 1 and day2 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
effect on oxygenation
effect on compliance of the lung
determining optimal PEEP |
baseline, post-recruitment on day 1 & day 2 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
30/12/2024 |
| 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="0"
Months="8"
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
|
ventilator induced lung injury (VILI) is the damage to the lung tissue caused by the external energy to lung parenchyma in the form of tidal volume and application of PEEP during mechanical ventilation. lung strain has been identified as surrogate marker to determine VILI. determining lung strain can help in personalizing the ventilation parameters in ARDS patients and reducing the likelihood of VILI. the aim of the study was to compare dynamics of lung strain changes after incremental and decremental PEEP recruitment maneuver. the patients enrolled for the study were mechanically ventilated using GE CARESCAPE 860 ventilator which is equipped with an integrated airway gas module which records the data and calculates end expiratory lung volume (EELV). the patients were allocated into two groups I and D based on computer generated randomization. The ventilator parameters were adjusted as per standard ARDS protocol using assist control volume control mode and patients were sedated and paralysed using fentanyl and atracurium and baseline vitals, ventilation parameters, ABG values and airway pressures and compliance of the lung were noted. in Group I, incremental PEEP maneuver from 5 cm H2O to 25 cm H2O with change of 5 cm H2O at each step was performed and in Group D , decremental PEEP maneuver from 25 cm H2O to 5 cm H2O with a change of 5 cm H2O at each step was performed on day 1. On the second day, decremental PEEP maneuver was performed in Group I patients and Incremental PEEP maneuver was performed in Group D . the parameters studied were EELV, compliance, peak airway pressure at each level of PEEP, lung strain, post-recruitment values of airway pressures, ABG analysis including pH, PaCO2, PaO2 and static compliance of lung. |