| CTRI Number |
CTRI/2019/03/018312 [Registered on: 29/03/2019] Trial Registered Prospectively |
| Last Modified On: |
25/03/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two ventilatory modes on arterial and end tidal carbon dioxide in robotic surgery. |
|
Scientific Title of Study
|
Comparison of arterial to end tidal Carbon Dioxide gradient (Pa-ETCO2), in volume versus pressure controlled ventilation in patients undergoing robotic abdominal surgery in Trendelenberg Position (A randomised controlled study) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lakshmi Kumar |
| Designation |
Professor |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Tower 6 floor 1
Department of Anaesthesia
Ponnekara
Amrita Lane
Ponekara
Kochi
Ernakulam
KERALA
682041
India |
| Phone |
09496211333 |
| Fax |
|
| Email |
lakshmi.k.238@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sugashini V |
| Designation |
Junior Resident |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Anaesthesiology
Tower 6 Floor 1
Amrita lane
Ponekara
Kochi
Ernakulam
KERALA
682041
India |
| Phone |
04842856161 |
| Fax |
|
| Email |
sugashiniv28@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sugashini V |
| Designation |
Junior Resident |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Anaesthesiology
Tower 6 Floor 1
Amrita lane
Ponekara
Kochi
Ernakulam
KERALA
682041
India |
| Phone |
04842856161 |
| Fax |
|
| Email |
sugashiniv28@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita Institute of Medical Sciences and Research Centre
Amrita Lane
Ponnekara
Kochi 682041 |
|
|
Primary Sponsor
|
| Name |
Amrita Institute of Medical Sciences |
| Address |
Amrita Lane
Ponekara
Kochi |
| 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 |
| Lakshmi Kumar |
Amrita Institute Of Medical Sciences |
Department of Anaesthesiology and Critical Care
Tower 6 floor 1
Amrita Lane
Ponekara
Kochi
Ernakulam
KERALA |
9496211333
2802020
lakshmi.k.238@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amrita Institute Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N429||Disorder of prostate, unspecified, (2) ICD-10 Condition: N398||Other specified disorders of urinary system, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pressure controlled ventilation in Trendelenberg position during robotic surgery |
Patients randomised to receive pressure controlled ventilation targeting a PaCO2 of 35-40 mm Hg. Arterial samples measured at defined time points and the gradient between arterial and end tidal carbon dioxide obtained |
| Comparator Agent |
Volume controlled ventilation in trendelenberg position during robotic surgery |
Randomised to receive volume controlled ventilation targetted to an end tidal concentration of 35-40 mm Hg.
Samples of blood gases at defined time intervals are to be obtained and the arterial to end tidal carbon dioxide gradient measured. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Scheduled to undergo robotic surgery in Trendelenberg position lasting for more than 2 hours. |
|
| ExclusionCriteria |
| Details |
BMI > 35, ASA physical status III and above, respiratory disease and cardiac disease affecting ventilatory function. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Arterial to end tidal carbon dioxide gradient measurement between pressure versus volume controlled ventilation |
1.Baseline in room air (T0)
2. 10 minutes after pnuemoperitoneum (T1)
3. 2 h after surgery (T2)
4. 2 hrly during surgery (T3, T4)
5. 10 mins after deflation of pnuemoperitoneum (Te)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Alveolar to arterial gradient (A-a)DO2
2.Peak airway pressure
3. Dynamic Compliance C dyn
4. P/F ratio |
Baseline in room air (T0)
10 minutes after pnuemoperitoneum (T1)
2 h after surgery (T2)
2 hrly during surgery (T3, T4)
10 mins after deflation of pnuemoperitoneum (Te)
|
|
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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
|
N/A |
|
Date of First Enrollment (India)
|
11/04/2019 |
| 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="1"
Months="6"
Days="5" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Minimally invasive surgeries are progressively replacing open surgeries. The ideal ventilatory strategy resulting in optimal lung dynamics is poorly understood. We aim to evaluate the gradient of arterial carbon dioxide to the end tidal value between pressure and volume controlled ventilation during robotic surgery in the Trendelenberg position. We also aimed to compare the arterial to alveolar oxygen gradient, peak airway pressures, dynamic compliance and p/F ratio between the two modes with an aim to identify the superior mode for these patients. |