| CTRI Number |
CTRI/2024/04/066539 [Registered on: 30/04/2024] Trial Registered Prospectively |
| Last Modified On: |
19/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia Other (Specify) [Intervention in ventilation strategy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Modified approach of providing breaths to reduce lung problems under anesthesia in patients undergoing lumbar spine surgeries. |
|
Scientific Title of Study
|
Driving pressure guided ventilation on postoperative pulmonary complications in lumbar spine surgeries: A double blinded randomised control study |
| Trial Acronym |
DPV |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Stanly Joe Saju |
| Designation |
Post graduate |
| Affiliation |
St Johns Medical College and Hospital, Bangalore |
| Address |
Department of Anesthesiology
St Johns Medical College and Hospital Sarjapura road Koramangala
Bengaluru-560034 St. Johns Medical College and Hospital, Sarjapura road, Koramangala
Bengaluru-560034 Bangalore KARNATAKA 560034 India |
| Phone |
09745903570 |
| Fax |
|
| Email |
stanlyjoesaju@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr MManjuladevi |
| Designation |
Professor |
| Affiliation |
St Johns Medical College and Hospital,Bangalore |
| Address |
Department of Anesthesia and Critical Care
St. Johns Medical College and Hospital.
Bengaluru-560034 Department of Anesthesia and Critical Care
St. Johns Medical College and Hospital.
Bengaluru-560034 Bangalore KARNATAKA 560034 India |
| Phone |
09449059395 |
| Fax |
|
| Email |
drmanjula95@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Stanly Joe Saju |
| Designation |
Post graduate |
| Affiliation |
St Johns Medical College and Hospital, Bangalore |
| Address |
Department of Anesthesia and Critical Care
St. Johns Medical College and Hospital.
Bengaluru-560034 Department of Anesthesia and Critical Care
St. Johns Medical College and Hospital.
Bengaluru-560034 Bangalore KARNATAKA 560034 India |
| Phone |
9745903570 |
| Fax |
|
| Email |
stanlyjoesaju@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesia and Critical Care
St. Johns Medical College and Hospital.
Bengaluru-560034 |
|
|
Primary Sponsor
|
| Name |
St.Johns Medical College and Hospital |
| Address |
Room no 7 OT Complex,2nd floor,St. Johns Medical College and Hospital, Sarjapur-Marathahalli Rd, beside Bank of Baroda, John Nagar, Koramangala
Bengaluru-560034 |
| Type of Sponsor |
Private 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 |
| Stanly Joe Saju |
St. Johns Medical College and Hospital |
Room No. 7 OT Complex,2nd floor St. Johns Medical College and Hospital
Sarjapura road Kormangala
Bengaluru-560034 Bangalore KARNATAKA |
9745903570
stanlyjoesaju@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, St.Johns Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional ventilation (CV) group |
Patients will be ventilated in Volume Control Ventilation mode,Fractional inspired oxygen(FiO2):0.5,Positive end expiratory pressure(PEEP)of 5,Respiratory rate of 12-14/min to maintain EtCO2 32-36 mmHg,Inspiratory:Expiratory ratio of 1:2,Tidal volume of 6ml/kg. |
| Intervention |
Driving pressure ventilation group (DV) |
Above ventilation will be set along with recruitment which involves gradual increase of PEEP from 5 to 10 and then to 15cm H2O every
5 breaths. After 10 breaths, PEEP will be decreased to 10. Driving pressure will be measured at the 10th respiratory cycle . A slow decrease of PEEP every 2cm H2O for every 10 breaths will be done . At the end of
10th respiratory cycle in each PEEP, the Driving pressure will be calculated. Thereafter, the patient will be
ventilated with the PEEP corresponding to the lowest DP for the next hour. Repeat cycle of
recruitment and lowest DP based ventilation will be done every hour until the end of surgery.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and II patient with well controlled comorbidities;BMI less than 30 |
|
| ExclusionCriteria |
| Details |
Patients with known chronic obstructive pulmonary disease, bronchial asthma,
hyperactive airway and interstitial lung diseases ischemic heart disease, severe hepatic or renal dysfunction, musculoskeletal disease. |
|
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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 assess the effect of driving pressure guided ventilation and mechanical power on
occurrence of postoperative pulmonary complications in patients undergoing lumbar spine
surgeries |
Postoperatively patients will be followed up for Postop pulmonary complications at 12 hours, Postoperative day 1, Postoperative day 3 and Postoperative day 7 or at
the time of discharge whichever is earliest. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the effect of driving pressure on intraoperative hemodynamics between
conventional and driving pressure guided ventilation groups. |
Hemodynamic parameters will be noted every 15 mins intraoperatively till end of surgery . |
To assess the effect of respiratory indices,Arterial blood gas(ABG) and Lung ultrasound(LUS), on postoperative pulmonary complications(PPC) occurrence between
conventional ventilation group and driving pressure guided ventilation group. |
Respiratory indices will be noted every 15 mins intraoperatively.
Arterial blood gas(ABG) will be done postinduction and pre-extubation.
Lung ultrasound(LUS) will be done preinduction,postanaesthesia care unit(PACU) and postoperative day3.
|
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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 4 |
|
Date of First Enrollment (India)
|
15/05/2024 |
| 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 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
|
Background- Postoperative pulmonary complications (PPCs) are common and increase patient mortality. PPC includes respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, and aspiration pneumonitis.General anaesthesia and mechanical ventilation are important causative factors for PPC’s. One of the most common complications of spine surgeries are PPC as the surgery is done in prone position and can be a long duration surgery.
- The newest concept of driving pressure (DP) ventilation and mechanical power has shown to reduce PPCs in surgical patients. DP ventilation is (Pplat- PEEP) and is the pressure required for alveolar opening.Mechanical power refers to the quantity of energy per unit of time, measured in joules per minute (J/min). It is calculated as 0.098 x VT x respiratory rate x [(Ppeak -(0.5 x DP)]
Purpose and need of the study - The effect of driving pressure guided ventilation on different types of surgeries is practiced although its effect on lumbar spine surgeries has not been explored. Our aim is to assess the association of driving pressure and mechanical power on the occurrence on postoperative pulmonary complications in lumbar spine surgeries.
Methodology - Patients are randomised into two groups: Conventional ventilation group and Driving pressure guided ventilation group. A sample size of 50 with 25 in each group will be recruited. R programming version 4.1.2(R core team 2023,Vienna,Austria) will be the software used for statistical analysis. Descriptive statistics will be summarized with Mean ± SD for continuous variables and Number (%) for categorical values. Inferential statistics will be done using Student t test for continuous variables and Chi square test to test the association of outcome between the groups.- Standard anesthesia will be given to these patients along with a postinduction Arterial blood gas(ABG) .Patient will be positioned prone and ventilated with the following settings based on the group:
- Conventional ventilation (CV) group: Volume controlled mode(VCV), Fractional inspired oxygen (FiO2)-0.5, Positive end expiratory pressure(PEEP) 5 cm H2O, Respiratory rate(RR)-12-14/min to maintain EtCO2 32-36 mm Hg, Inspiratory: Expiratory ratio(I:E)=1:2,Tidal volume(VT)-6ml/kg predicted body weight(pbw).
- Driving pressure ventilation group (DV):Along with conventional settings , recruitment which involves gradual increase of PEEP from 5 to 10 and then to 15cm H2O for every 5 breaths will be done. After 10 breaths, a decrease of PEEP to 10 will be then done. Driving pressure will be measured at the 10th respiratory cycle. A slow decrease of PEEP every 2cm H2O (from 10 to 8 and then to 6) after every 10 breaths will be done. At the end of 10th respiratory cycle in each PEEP, the DP will be calculated. Thereafter, the patient will be ventilated with the PEEP corresponding to the lowest DP for the next hour. Repeat cycle of recruitment and lowest DP based ventilation will be done every hour until the end of surgery.
- Every 15 min, hemodynamic parameters and ventilatory parameters will be noted. Pre extubation ABG will be done and postoperatively patients will be followed up for PPCs at 12 hours, postopday(POD)1, POD3 and POD7 or at the time of discharge whichever is earliest. A lung ultrasound will be done on POD3 in the ward to identify any signs of PPCs.
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