| CTRI Number |
CTRI/2019/09/021289 [Registered on: 17/09/2019] Trial Registered Prospectively |
| Last Modified On: |
13/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Ventilatory mode] |
| Study Design |
Other |
|
Public Title of Study
|
A study comparing different types of breathing supports in robotic surgeries |
|
Scientific Title of Study
|
Prospective randomised study comparing respiratory dynamics using pressure controlled volume guaranteed mode to conventional modes in elective robotic pelvic surgeries under general anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Apoorva Naik |
| Designation |
Junior resident |
| Affiliation |
Narayana Hrudayalaya |
| Address |
Department of anaesthesia,
4th floor, A Block,
Mazumdar shaw medical center, Narayana Health city
Bangalore
Bommasandra Industrial Area,
Bangalore.
Bangalore Rural
KARNATAKA
560099
India |
| Phone |
9972195395 |
| Fax |
|
| Email |
anaik868@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Murugesan C |
| Designation |
Senior consultant |
| Affiliation |
Mazumdar Shaw Medical Centre,Narayana Hrudayalaya |
| Address |
Department of anaesthesia,
4th floor,A block,
Mazumdar shaw medical centre, Narayana Health City,
Bommasandra Industrial Area,Bangalore
Bommasandra Industrial Area,
Narayana Hrudyalaya,
Bangalore.
Bangalore Rural
KARNATAKA
560099
India |
| Phone |
9980553940 |
| Fax |
|
| Email |
murugesanhosur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Apoorva Naik |
| Designation |
Junior resident |
| Affiliation |
Narayana Hrudayalaya |
| Address |
4th floor Anaesthesia office,
Department of anaesthesia,
Mazumdar shaw medical center, Narayana Hrudayalaya, Bangalore
Bommasandra Industrial Area,
Narayana Hrudyalaya,
Bangalore.
Bangalore Rural
KARNATAKA
560099
India |
| Phone |
9972195395 |
| Fax |
|
| Email |
anaik868@gmail.com |
|
|
Source of Monetary or Material Support
|
| 4th floor anaesthesia office,
Mazumdar shaw medical centre,
Narayana Health city,
Bommasandra industrial area,
Bangalore. 560099 |
|
|
Primary Sponsor
|
| Name |
Narayana Hrudayalaya |
| Address |
Bommasandra Industrial Area,
Narayana Hrudayalaya,
Bangalore . |
| 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 |
| Dr Apoorva |
Narayana hrudayalaya |
5th floor ot complex, Mazumdar Shaw medical centre, Narayana hrudayalaya
, Bangalore
Bangalore
KARNATAKA |
9972195395
anaik868@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Narayana Health Academics Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ventilatory mode |
conventional modes Pressure control and volume control |
| Comparator Agent |
Ventilatory mode |
The effectiveness of pressure control volume guaranteed mode over conventional modes in improving the respiratory dynamics in elective robotic pelvic surgeries under general anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Adult Patients posted for elective robotic pelvic surgeries of either sex
ASA 1 & 2 |
|
| ExclusionCriteria |
| Details |
Recent respiratory infection <2 weeks
Neuromuscular disorders
Genetic disorders
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To compare the difference in peak airway pressure between the groups at ( T3) 30 minutes after pneumo insufflation since induction |
T3 is the time 30 minutes after pneumo insufflation and positioning |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the difference in ventilator parameters ( tidal volume, respiratory rate, dynamic compliance) between the groups at different time intervals
To compare the difference in respiratory parameters (end tidal carbon dioxide,oxygen saturation) between the groups.
To compare the difference in hemodynamic parameters (heart rate, mean arterial pressures) between the groups
|
T0 is 5 minutes after intubation
T1 is 10 minutes after induction & intubation in supine position.
T2 is the time 15 minutes after positioning & pneumo insufflation.
T3 is the time 30 minutes after pneumo insufflation
T4 is the time 60 minutes after pneumo insufflation
T5 is the time 10 minutes after bringing to supine positon & desufflation
|
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/09/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
7.Kim M S, Soh S, Kim Y S et al. Comparison of pressure ontrolled ventilation with volume guarantee and volume controlled 1:1 equal ratio ventilation on oxygenation and resptratory mechanic during robot assisted laparoscopic radical prostatectomy: a Randomised controlled trial. Int J Med Sci 2018;15(13):1522-1529.
8.Gad M, Gaballa K, Abdallah A et al. Pressure controlled ventilation with volume guarantee compared to volume controlled ventilation with equal ratio in obese patients undergoing laparoscopic hysterectomy.Anaesth Essays Res 2019; 13: 347-53.
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
prospective randomised study comparing respiratory dynamics using pressure controlled volume guaranteed mode to conventional modes in robotic pelvic surgeries under general anaesthesia to study its effects on oxygenation, compliance and gas exchange |