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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  
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 
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  
Status 
Not Applicable 
 
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. 
 
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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