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CTRI Number  CTRI/2025/02/080999 [Registered on: 20/02/2025] Trial Registered Prospectively
Last Modified On: 21/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of two different ventilation strategies during general anaesthesia for reducing lung complications after robotic surgeries of abdomen and pelvis 
Scientific Title of Study   Comparison of Modified Lung Ultrasound Score (LUSS) in patients undergoing robot assisted abdominal and pelvic surgeries in Trendelenburg position under general anesthesia with driving pressure targeted individualized PEEP versus empiric fixed PEEP - A Randomized Controlled 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  Ananya Kabi 
Designation  Junior Resident 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry. 
Address  Department of Anesthesiology and Critical Care Anesthesia Office 2nd Floor IPD block Jawaharlal Institute of Postgraduate Medical Education and Research Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9958895883  
Fax    
Email  ananyakabi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Anusha Cherian 
Designation  Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry. 
Address  Department of Anesthesiology and Critical Care Anesthesia Office 2nd Floor IPD block Jawaharlal Institute of Postgraduate Medical Education and Research Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9789197801  
Fax    
Email  anushacherian@gmail.com  
 
Details of Contact Person
Public Query  
Name  Anusha Cherian 
Designation  Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry. 
Address  Department of Anesthesiology and Critical Care Anesthesia Office 2nd Floor IPD block Jawaharlal Institute of Postgraduate Medical Education and Research Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9789197801  
Fax    
Email  anushacherian@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry. 
 
Primary Sponsor  
Name  Ananya Kabi 
Address  Junior Resident, Department of Anesthesiology and Critical Care, Anesthesia Office, 2nd Floor IPD Block, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry. 
Type of Sponsor  Other [Self] 
 
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 
Anusha Cherian  Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER)  Department of Anesthesiology and Critical Care 2nd Floor IPD block JIPMER Pondicherry
Pondicherry
PONDICHERRY 		 9789197801

anushacherian@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Interventional Studies  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 Venilation Guided PEEP  Tidal volume will be 7 ml per kg Predicted body weight Respiratory Rate will be set to target EtCO2 between 35 to 40mm Hg FiO2 set to target SpO2 more than 98 percentage PEEP set at 6 cm H20  
Intervention  Driving Pressure Guided PEEP  Mode of ventilation is VCV Tidal volume will be 7 ml per kg PBW RR to target EtCO2 of 35 to 40 mm Hg FiO2 to target SpO2 more than 98 percentage PEEP will be 6cm H20 After pneumoperitoneum, PEEP shall be increased in steps of 1 cm H2O from 6 up to 12 to achieve and maintain a PEEP which results in Driving pressure up to 13cm H2O. Each PEEP level will be set for 10 breaths  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Patients between 18 and 75 years of age, American Society of Anesthesiologists physical status II or III, body mass index between 18 kg per m2 and 35 kg per m2, with intermediate to high ARISCAT score ,that is more than 26, planned for robotic abdominal and pelvic surgeries under general anesthesia in Trendelenburg position
2. Duration of surgery more than 3 hours, from the time of creation of the pneumoperitoneum, like surgeries for prostate, rectum, total laparoscopic hysterectomy, etc.
3. Patients expected to be extubated on table post
operatively
 
 
ExclusionCriteria 
Details  1. Patients with history of acute respiratory distress
Syndrome
2. Emergency surgery
3. History of previous lung surgery
4. History of mechanical ventilation within 2 weeks before recruitment
5. Pregnant patients
6. Patients with cardiac comorbidities of NYHA class III
and IV
7. Patients with valvular heart diseases
8. Patients with history of stroke
9. Patients with elevated intracranial pressure
10. Severe Chronic obstructive pulmonary disease
with Forced expiratory volume to Forced vital
capacity ratio less than 60 percent
11. History of progressive neuromuscular illness
12. Participation in another study
13. Refusal to participate
14. Anaesthesiologist unwilling to adhere to the ventilation mode as specified 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare LUSS in patients with intermediate to high risk of PPCs, that is ARISCAT score more than2 6, undergoing robot assisted abdominal and pelvic surgeries under general anesthesia in Trendelenburg position with driving pressure directed individualized PEEP versus empiric fixed PEEP   Lung ultrasound will be conducted pre-induction (t1), end of surgery pre extubation (t2), post extubation (t3) 
 
Secondary Outcome  
Outcome  TimePoints 
1.To compare the differences in peak inspiratory pressure (PIP), plateau pressures, PEEP, Partial pressure of oxygen in arterial blood/Fraction of inspired oxygen (PaO2/FiO2) in patients undergoing robotic abdominal and pelvic surgeries under general anesthesia with intraoperative targeted driving pressures and conventional ventilation strategies
2. To compare the incidence of postoperative pulmonary complications (PPC) in patients undergoing laparoscopic abdominal surgeries under general anesthesia between the groups
3. To correlate the Lung ultrasound score to development of postoperative pulmonary complications
4. To compare the serum levels of HS-CRP, TNF-α and IL-1β in patients undergoing robotic abdominal and pelvic surgeries under general anesthesia with
intraoperative targeted driving pressures and conventional ventilation strategies 		 Recordings will be done at 5 predefined time points, after intubation (t1), 10 minutes after pneumoperitoneum and Trendelenburg (t2), 1 hour(t3) and 2 hours (t4) after t2 and 10 minutes after PEEP has been reset before extubation (t5) for Peak and plateau pressures, PEEP and compliance and ABG for PaO2/FiO2, A-a gradient, PCO2.
Blood samples for serum markers will be collected pre induction (t1) and post extubation (t2). 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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   N/A 
Date of First Enrollment (India)   03/03/2025 
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
Robotic surgery, while offering ergonomic benefits, can lead to increased intra-abdominal pressure (due to CO2 insufflation) and the Trendelenburg position, both of which heighten the risk of PPCs, including atelectasis. To mitigate these risks, lung protective ventilation strategies are recommended, but the optimal level of positive end-expiratory pressure (PEEP) remains unclear.
   
Study Hypothesis
Ventilation strategies targeting driving pressure—defined as the difference between plateau pressure and PEEP—will lead to lower lung ultrasound scores (LUSS) and reduced PPCs compared to conventional ventilation strategies using fixed PEEP. The driving pressure-based strategy will individualize PEEP levels to minimize atelectasis and other pulmonary complications.

Previous Research
In a prior study, the authors found that driving pressure-directed PEEP resulted in higher lung compliance, lower plateau pressures, and fewer lung injury biomarkers compared to fixed PEEP, although PPCs did not differ significantly.

Objectives:
Primary Objective: To compare LUSS (a proxy for atelectasis) in patients at high risk for PPCs undergoing robotic surgeries with driving pressure-directed PEEP vs conventional fixed PEEP.
Secondary Objectives:
  1. Compare peak inspiratory pressure (PIP), plateau pressure, PEEP, and PaO2/FiO2.
  2. Compare the incidence of PPCs between the two groups.
  3. Correlate LUSS with PPC development.
  4. Measure the levels of serum biomarkers (e.g., HS-CRP, IL-1β) to assess inflammation and lung injury.

Study Design:
- Participants:Adults (18-75 years) with ASA II or III, BMI 18-35 kg/m², and ARISCAT score >26, undergoing robotic abdominal/pelvic surgery.
- Interventions:
  - Group DP (Targeted PEEP): PEEP adjusted to maintain a driving pressure of ≤13 cm H2O.
  - Group C (Conventional PEEP): Fixed PEEP of 6 cm H2O.
  
- Randomization: Block randomization, with allocation concealment and double blinding.
- Data Collection: Measurements at multiple time points during surgery (e.g., PIP, plateau pressure, PEEP, LUSS, biomarkers). Lung ultrasound performed pre- and post-surgery to assess aeration and atelectasis.

Study Outcomes
1. LUSS: Used to assess lung aeration, with scores ranging from 0 (normal) to 3 (severe consolidation). 
2. PPCs: Defined using a detailed classification (Grade 0–5), with Grade 2 or higher including clinically significant complications like atelectasis, hypoxemia, or pneumonia.
3. Biomarkers: Serum levels of HS-CRP and IL-1β will be measured pre- and post-surgery to evaluate the inflammatory response.

Inclusion/Exclusion Criteria:
- Inclusion: Patients with ARISCAT score >26, undergoing surgeries like prostate, rectal, and hysterectomy.
- Exclusion: Conditions like COPD, cardiac comorbidities, or pregnancy, among others.

Study Procedure

1. Preoperative Phase:

   - Patient Enrollment: Patients aged 18-75 with an ARISCAT score >26 and scheduled for robotic abdominal/pelvic surgeries in the Trendelenburg position are enrolled.

   - Consent: Written informed consent is obtained from all patients.

   - Randomization: After preoperative assessment, patients are randomly assigned to one of two groups:

     - Group DP: Targeted driving pressure-based PEEP.

     - Group C: Conventional PEEP (fixed).

   - Preoperative Data Collection:

     - Baseline lung ultrasound is performed.

     -Baseline serum sample is collected

     - Preanesthetic assessment (including medical history, BMI, ASA status, etc.) is recorded.

 

2. Intraoperative Phase:

   - Anesthesia and Ventilation Setup:

     - General anesthesia is induced with fentanyl, propofol, and vecuronium.

     - Routine monitoring is established (e.g., ECG, blood pressure, SpO2).

     - Volume-controlled ventilation is initiated with a tidal volume of 7 ml/kg and respiratory rate aimed at maintaining ETCO2 between 35-40 mmHg.

     - PEEP is set to 6 cm H2O in both groups at the start.

  

   -Pneumoperitoneum and Trendelenburg Position:

     - After creating pneumoperitoneum and positioning the patient in Trendelenburg, ventilation adjustments are made:

       - Group DP: PEEP is increased stepwise to maintain a driving pressure ≤ 13 cm H2O.

       - Group C: PEEP remains fixed at 6 cm H2O.

  

   - Ventilation Monitoring and Adjustments:

     - Plateau pressures, PEEP, and compliance are monitored throughout surgery.

     - Lung ultrasound is performed intraoperatively (post-pneumoperitoneum and Trendelenburg) to assess lung aeration.

     - If necessary, adjustments to PEEP, FiO2, or recruitment maneuvers may be performed based on intraoperative desaturation (SpO2 ≤ 95%) or hypotension.

 

3. Postoperative Phase:

   - Post-surgery Extubation:

     - After surgery, patients are extubated if they meet the criteria (e.g., TOF ratio >0.9, spontaneous breathing, adequate response to commands).

  

   - Postoperative Monitoring:

     - Lung ultrasound is repeated immediately post-extubation and 15-30 minutes later to assess for changes in lung aeration.

     - Blood samples are collected for analysis of serum biomarkers (IL-1β, HS-CRP).

     - Postoperative complications (PPCs) are monitored for up to 3 days post-surgery.

     - Chest X-ray is performed on postoperative day 1 to assess for signs of atelectasis or other pulmonary complications.

 

4. Outcome Measurement:

   - Primary Outcome:

     - Lung ultrasound score (LUSS) is used to assess the extent of lung aeration and atelectasis

   - Secondary Outcomes:

     - PPCs are graded from 0 (no symptoms) to 5 (death) based on clinical findings.

     - Serum levels of inflammatory markers (HS-CRP, IL-1β) are compared between the groups to assess the degree of inflammation and lung injury.

 

5. Follow-up:

   - Patients are followed up for 3 days postoperatively to monitor for any respiratory symptoms.

   - Those discharged before the follow-up period will be contacted telephonically to assess any delayed symptoms.


Ethical Considerations
- The study will be conducted under standard anesthesia protocols with ethics approval and informed consent.
- Data monitoring will ensure safety, with an interim analysis planned after 50% of the participants are enrolled.

Conclusion
The study seeks to establish whether personalized ventilation strategies based on driving pressure can reduce postoperative pulmonary complications and improve lung function in patients at higher risk of PPCs undergoing robotic surgeries. If successful, this approach could lead to more tailored, effective ventilation strategies in high-risk surgical populations, reducing atelectasis and improving overall outcomes.
 
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