| CTRI Number |
CTRI/2019/06/019791 [Registered on: 20/06/2019] Trial Registered Prospectively |
| Last Modified On: |
18/06/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of Effect on the heart function of patients with Heart disease following insufflation of Carbon di Oxide into the abdomen for the conduct of laparoscopic gall bladder removal surgery |
|
Scientific Title of Study
|
Evaluation of hemodynamic changes during laparoscopic cholecystectomy in patients with moderate to severe left ventricular dysfunction- A prospective observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Versha |
| Designation |
MD Anaesthesia |
| Affiliation |
PGIMER |
| Address |
Office Of Department of Anaesthesia, 4th floor, Nehru Hospital, PGIMER, Chandigarh-160012
Office Of Department of Anaesthesia, 4th floor, Nehru Hospital, PGIMER, Chandigarh-160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9418820286 |
| Fax |
|
| Email |
varshasapehia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prerna Varma |
| Designation |
Assistant Professor |
| Affiliation |
PGIMER |
| Address |
Office Of Department of Anaesthesia, 4th floor, Nehru Hospital, PGIMER, Chandigarh-160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087003391 |
| Fax |
|
| Email |
prerna.varma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
VERSHA |
| Designation |
MD Anaesthesia |
| Affiliation |
PGIMER |
| Address |
Office Of Department of Anaesthesia, 4th floor, Nehru Hospital, PGIMER, Chandigarh-160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9418820286 |
| Fax |
|
| Email |
varshasapehia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, Office Of Department of Anaesthesia, 4th floor, Nehru Hospital, PGIMER, Chandigarh-160012 |
|
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Primary Sponsor
|
| Name |
Department of Anesthesia PGIMER |
| Address |
Office Of Department of Anaesthesia, 4th floor, Nehru Hospital, PGIMER, Chandigarh-160012 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Versha |
PGIMER CHANDIGARH |
Office Of Department of Anaesthesia, 4th floor, Nehru Hospital, PGIMER, Chandigarh-160012
Chandigarh
CHANDIGARH |
6283049894
varshasapehia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE, PGIMER |
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: K80-K87||Disorders of gallbladder, biliary tract and pancreas, (2) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (3) ICD-10 Condition: I519||Heart disease, unspecified, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient planned for laproscopic cholecystectomy
2.Consent to participation
3.Age 18 to 65 years
4.Patient with echocardiography findings consistent with presence of moderate to severe left ventricular dysfunction for the study group |
|
| ExclusionCriteria |
| Details |
1.BMI >35kg/m2
2.Coexisting stenotic valve lesion or right ventricular dysfunction
3.presence of electrcardiographic finding of arrhythmia
4.NYHA 1V physical status
5.End stage hepatic/renal/pulmonary disease |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of effect of pneumoperitoneum on CO and CI in patients with moderate to severe left ventricular dysfunction. |
All study parameters shall be recorded at the following time points. Pre-induction (T1), 10 minute after induction (T2), when pneumoperitoneum with intra-abdominal (IAP) pressure of 12mm Hg is achieved (T3), 10 minute after reverse Trendelenburg position(T4), 10 minute after deflation of pneumoperitoneum (T5). |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of effect of pneumoperitoneum on hemodynamic parameters and cardiac function in patients with and without cardiac disease. |
All study parameters shall be recorded at the following time points. Pre-induction (T1), 10 minute after induction (T2), when pneumoperitoneum with intra-abdominal (IAP) pressure of 12mm Hg is achieved (T3), 10 minute after reverse Trendelenburg position(T4), 10 minute after deflation of pneumoperitoneum (T5). |
|
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/07/2019 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The present study shall be an open label cohort observational study. Patients with moderate to severe left ventricular dysfunction undergoing laparoscopic cholecystectomy shall be monitored with advance hemodynamic monitors like Flotrac and transthoracic echocardiography to study the effect of pneumoperitoneum on the hemodynamics. Consecutive ASA 1 patients shall also be studied for effect on hemodynamics following creation of pneumoperitoneum. |