| CTRI Number |
CTRI/2018/06/014648 [Registered on: 28/06/2018] Trial Registered Retrospectively |
| Last Modified On: |
26/06/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To find out the minimum head down position required in laprascopic surgeries under general anaesthesia |
|
Scientific Title of Study
|
Comparative study to evaluate the effect of degree of Trendelenburg position on the respiratory dynamics with pressure controlled volume guaranteed ventilation during laparoscopic surgeries in obese and non obese patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Meenoti Potdar |
| Designation |
Consultant Anaesthesiologist and Academic Co-ordinator |
| Affiliation |
Dr. Lakhumal Hiranand Hiranandani Hospital |
| Address |
Department of Anaesthesia,
Hillside Avenue,
Hiranandani Gardens
Powai, Mumbai
Hillside Avenue,
Hiranandani Gardens
Powai, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400076
India |
| Phone |
9920627839 |
| Fax |
|
| Email |
meenoti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meenoti Potdar |
| Designation |
Consultant Anaesthesiologist and Academic Head |
| Affiliation |
Dr. Lakhumal Hiranand Hiranandani Hospital |
| Address |
Department of Anaesthesia,
Dr L H Hiranandani Hospital
Hillside Avenue
Hiranandani Gardens
Powai
Mumbai
Mumbai (Suburban)
MAHARASHTRA
400076
India |
| Phone |
9920627839 |
| Fax |
|
| Email |
meenoti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chhavi Khandelwal |
| Designation |
Secondary DNB resident |
| Affiliation |
Dr. Lakhumal Hiranand Hiranandani Hospital |
| Address |
Department of Anaesthesia
Dr L H Hiranandani Hospital
Hillside Avenue
Hiranandani Gardens
Powai
Mumbai
Mumbai (Suburban)
MAHARASHTRA
400076
India |
| Phone |
9521088934 |
| Fax |
|
| Email |
drchhavi12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr L H Hiranandani Hospital
Hillside Avenue
Hiranandani Gardens
Powai
Mumbai |
|
|
Primary Sponsor
|
| Name |
Dr L H Hiranandani Hospital |
| Address |
Hillside Avenue Hiranandani gardens Powai Mumbai |
| 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 Meenoti Potdar |
Dr L H Hiranandani Hospital |
Operation Theatre,
2nd floor
Dr L H Hiranandani Hospital
Hillside Avenue
Hiranandani Gardens
Powai
Mumbai
Mumbai (Suburban)
MAHARASHTRA |
9920627839
meenoti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Dr L H Hiranandani Hospital Powai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA Grade I and 2, non pregnant, of both sexes, age of 18 to 70 years, BMI between 20 to 40,consenting for general anaesthesia for laprascopic surgery lasting for 30 minutes to 3 hours , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Non Obese patients (Group NB) |
Various degree of Trendelenburg position at O,5,10,15,20 degree will be given with and without creation of pneumoperitoneum and its effects on the respiratory parameters like airway pressures, dynamic compliance and oxygen saturations would be assessed in non obese patients during the intraoperative period for a maximum of 180 minutes |
| Intervention |
Obese patients (Group O) |
Various degree of Trendelenburg position at O,5,10,15,20 degree will be given with and without creation of pneumoperitoneum and its effects on the respiratory parameters like airway pressures, dynamic compliance and oxygen saturations would be assessed in obese patients during the intraoperative period for a maximum of 180 minutes |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with ASA 1 and 2
2. Duration of anaesthesia lasting form 30 minutes up to 240 minutes
3. Age 18 to 70 years
4. Weight > 40kgs
5. Patients giving valid written consent
6. BMI 18.5 and £ 40 |
|
| ExclusionCriteria |
| Details |
1. Patient refusal to be included in the study 2. Patients with cardio-respiratory disease
3. EtCO2 ³ 50 preoperatively
4. Saturation £ 90 % on room air preoperatively 5. Pregnant patients and lactating mothers
6. Chronic heavy smoker
7. Chronic alcoholics
8. Patients with neuromuscular disorder
9. Conversion of laparoscopic surgery to open surgery at any point in time |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the effect of pneumoperitoneum in obese and non-obese patients on the respiratory dynamics like peak inspiratory pressure, mean airway pressure and the dynamic compliance of the lungs during laparoscopic surgeries with different degree of Trendelenburg position. |
To evaluate and compare the effect of pneumoperitoneum in obese and non-obese patients on the respiratory dynamics like peak inspiratory pressure, mean airway pressure and the dynamic compliance of the lungs during laparoscopic surgeries in supine position and with different degree of Trendelenburg position 5, 10,15 and 20 degree with and without pneumoperitoneum intraoperatively during the surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the changes in hemodynamic parameters during laparoscopic surgeries in different degree of Trendelenburg position in obese and non-obese patients.
2. To assess the ideal degree of angulation for best visualization of operating field with the least effect on the respiratory and hemodynamic parameters.
3. To assess the effect on carbon dioxide elimination and oxygen saturation. |
1.To assess the changes in hemodynamic parameters during laparoscopic surgeries in different degree of Trendelenburg position in obese and non-obese patients.- At all time points intraoperatively
2. To assess the ideal degree of angulation for best visualization of operating field with the least effect on the respiratory and hemodynamic parameters. -Intraoperatively
3. To assess the effect on carbon dioxide elimination and oxygen saturation.- Intraoperatively |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
26/02/2018 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is designed to evaluate and compare the effect of degree of Trendelenburg tilt on the respiratory dynamics and the haemodynamics during laprascopic abdominal surgeries and to see the effect of obesity on these parameters |