| CTRI Number |
CTRI/2025/03/082369 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
09/03/2026 |
| 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 modes of ventilation ( Pressure Control and Volume Control ) in patients undergoing robot assisted urology surgery in steep Head down position - A prospective randomised controlled trial |
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Scientific Title of Study
|
Comparison of peri operative pulmonary outcomes in volume - controlled ventilation versus pressure - controlled ventilation in patients undergoing robot assisted urology surgery in trendelenburg position - A prospective randomised 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 |
Chhavi Sawhney |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Science, New Delhi. |
| Address |
1st floor Room number 125 , Jai Prakash Narayan Apex Trauma Centre, All India Institute of Medical Sciences , New Delhi - 110029
New Delhi
DELHI
110029
India |
| Phone |
9818357051 |
| Fax |
|
| Email |
drchhavisawhney@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Chhavi Sawhney |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Science, New Delhi. |
| Address |
1st floor Room number 125 , Jai Prakash Narayan Apex Trauma Centre, All India Institute of Medical Sciences , New Delhi - 110029
New Delhi
DELHI
110029
India |
| Phone |
9818357051 |
| Fax |
|
| Email |
drchhavisawhney@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sujethram P |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Science, New Delhi. |
| Address |
35 C , 4th floor , Room number 12, Hauz Khas, South Delhi, 110049 .
New Delhi
DELHI
110049
India |
| Phone |
9597402468 |
| Fax |
|
| Email |
sujethram2000@gmail.com |
|
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Source of Monetary or Material Support
|
| Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS, New Delhi. |
|
|
Primary Sponsor
|
| Name |
Chhavi Sawhney |
| Address |
First Floor Room number 125, Jai Prakash Narayan Apex Trauma Centre, All India Institute of Medical Sciences, New Delhi - 110029 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of Anaesthesiology Pain Medicine and Critical Care AIIMS New Delhi |
AIIMS , Ansari Nagar, New Delhi 110029 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chhavi Sawhney |
All India Institute of Medical Sciences , New Delhi. |
Department of Anaesthesiology, Room no. 5010 , 5th Floor, Teaching Block , AIIMS , Ansari Nagar, New Delhi .
South
DELHI |
9818357051
drchhavisawhney@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS, Delhi. |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pressure Controlled Ventilation |
Pressure Controlled ventilation is a mechanical ventilation strategy where breath is delivered to a patient at a set Airway pressure and Rate. |
| Comparator Agent |
Volume controlled ventilation |
Volume controlled ventilation is a mechanical ventilation strategy where breath is delivered to a patient at a given Volume and Rate. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
ASA I/II patients aged 18 - 75 years posted for robot assisted urology surgery in Trendelenburg position.
|
|
| ExclusionCriteria |
| Details |
Patients with BMI more than 35
Patients with Poor Cardiac Reserve
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Lung aeration as assessed by lung ultrasound score |
30 Minutes and 24 Hours after Surgery in the Post Operative Period. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Lung mechanics as measured by Peak airway pressure, Plateau pressure, Mean Airway Pressure, Static and Dynamic compliance , Expired Tidal Volume, Respiratory Rate. |
T0 - Baseline (After Induction of Anaesthesia)
T1 - Within 30 minutes after Pneumoperitoneum Inflation
T2 - Within 30 minutes after Trendelenburg Position
T3 - Within 2 hours after Trendelenburg Position
T4 - After Pneumoperitoneum deflation . |
| Gas exchange parameters as measured by ETCO2, PaCO2, P(a-ET)CO2 gradient, SpO2, PaO2, FiO2, PAO2 (Alveolar oxygen pressure) , Oxygenation factor, a/A ratio, AaDO2, PaO2/FiO2. |
T0 - Baseline (After Induction of Anaesthesia)
T1 - Within 30 minutes after Pneumoperitoneum Inflation
T2 - Within 30 minutes after Trendelenburg Position
T3 - Within 2 hours after Trendelenburg Position
T4 - After Pneumoperitoneum deflation . |
|
|
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)
|
21/03/2025 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Robot assisted urology surgeries are not only minimally invasive, these are also associated with increased accuracy, precision, reduced intra-operative blood loss and shorter length of hospital stay as compared to open surgery.(1) As a consequence, robot assisted surgeries are increasing worldwide. However, robot assisted surgery requires pneumoperitoneum and trendelenburg position (surgeries like robot assisted radical prostatectomy) for optimal exposure. Pneumoperitoneum leads to an increased intra- abdominal pressure and cephalad shift of the diaphragm. Similarly, trendelenburg position restricts diaphragm excursion and thoracic expansion.(2) These lead to decreased functional residual capacity, respiratory compliance, basal atelectasis and ventilation- perfusion mismatch.
There is literature available on the respiratory physiology, gas exchange, trans-pulmonary pressure and regional ventilation during robot assisted surgeries. Further, the effects of different levels of PEEP, recruitment manoeuvres and low tidal volume on gas exchange, pulmonary compliance and hemodynamics have also been evaluated.(3,4) The effect of ventilatory strategies like pressure controlled ventilation- volume guaranteed ( PCV-VG), PC- inverse ratio on oxygenation, gas exchange and post-operative pulmonary functions have also been compared.
The optimal ventilation strategy for robot assisted surgery is still controversial.We decided to compare the peri-operative pulmonary outcomes of pressure- controlled ventilation and volume- controlled ventilation in patients undergoing robot assisted urology surgery in Trendelenburg position. Lung Ultrasound Score is known well to correlate with peri-Operative Atelectasis [5]. For intra-operative pulmonary changes, we will be comparing the gas exchange and pulmonary mechanics between the two groups. As lung ultrasound score correlates well with the peri-operative atelectasis so we decided to assess the post-operative pulmonary outcomes by lung aeration score done in the immediate post-operative period and 24 hours later.
References
1. Yu H yin, Hevelone ND, Lipsitz SR, Kowalczyk KJ, Hu JC. Use, Costs and Comparative Effectiveness of Robotic Assisted, Laparoscopic and Open Urological Surgery. Journal of Urology [Internet]. 2012 Apr 1 [cited 2024 Oct 19];187(4):1392–9. Available from: https://doi.org/10.1016/j.juro.2011.11.089 2. Kaye AD, Vadivelu N, Ahuja N, Mitra S, Silasi D, Urman RD. Anaesthetic considerations in robotic-assisted gynecologic surgery. Ochsner J. 2013 Winter;13(4):517-24. PMID: 24358000; PMCID: PMC3865830. 3. Park JH, Park IK, Choi SH, Eum D, Kim MS. Volume-Controlled Versus Dual-Controlled Ventilation during Robot-Assisted Laparoscopic Prostatectomy with Steep Trendelenburg Position: A Randomised-Controlled Trial. J Clin Med. 2019 Nov 21;8(12):2032. doi: 10.3390/jcm8122032. PMID: 31766358; PMCID: PMC6947332. 4. Suh MK, Seong KW, Jung SH, Kim SS. The effect of pneumoperitoneum and Trendelenburg position on respiratory mechanics during pelviscopic surgery. Korean J Anesthesiol. 2010 Nov;59(5):329-34. doi: 10.4097/kjae.2010.59.5.329. Epub 2010 Nov 25. PMID: 21179295; PMCID: PMC2998653.
5 .Yu, Xin, et al. "Performance of lung ultrasound in detecting peri-operative atelectasis after general anesthesia." Ultrasound in medicine & biology 42.12 (2016): 2775-2784.
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