| CTRI Number |
CTRI/2023/12/060801 [Registered on: 27/12/2023] Trial Registered Prospectively |
| Last Modified On: |
22/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Diaphragm function comparison between patient undergoing robotic surgeries and laparotomies |
|
Scientific Title of Study
|
Comparison of the post-operative ultrasonographic assessment of diaphragmatic function in robotic assisted laparoscopic surgeries and laparotomies-a prospective observational study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepika Biswas |
| Designation |
Junior Resident |
| Affiliation |
All India institute of medical sciences,Jodhpur |
| Address |
All India institute of medical sciences,
emergency building, 4 Th floor anaesthesia and critical care, Jodhpur rajasthan All India institute of medical sciences,
emergency building, 4 Th floor anaesthesia and critical care, Jodhpur rajasthan Jodhpur RAJASTHAN 342005 India |
| Phone |
9330702901 |
| Fax |
|
| Email |
deepikawonderland@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Pradeep Bhatia |
| Designation |
Head of the department |
| Affiliation |
All India institute of medical sciences,Jodhpur |
| Address |
All India institute of medical sciences,
emergency building, 3 rd floor anaesthesia and critical care, Jodhpur rajasthan All India institute of medical sciences,
emergency building, 3 rd floor anaesthesia and critical care, Jodhpur rajasthan Jodhpur RAJASTHAN 342005 India |
| Phone |
9829159665 |
| Fax |
|
| Email |
pk_bhatia@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Pradeep Bhatia |
| Designation |
Head of the department |
| Affiliation |
All India institute of medical sciences,Jodhpur |
| Address |
All India institute of medical sciences,
emergency building, 3 rd floor anaesthesia and critical care, Jodhpur rajasthan All India institute of medical sciences,
emergency building, 3 rd floor anaesthesia and critical care, Jodhpur rajasthan
RAJASTHAN 342005 India |
| Phone |
9829159665 |
| Fax |
|
| Email |
pk_bhatia@yahoo.com |
|
|
Source of Monetary or Material Support
|
| AIIMS(All INDIA INSTITUTE OF MEDICAL SCIENCES)
Basni jodhpur Rajasthan
Pin-342005 |
|
|
Primary Sponsor
|
| Name |
All India institute of medical sciences |
| Address |
All India institute of medical sciences, Jodhpur Rajasthan |
| 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 Pradeep bhatia |
All India institute of medical sciences |
All India institute of medical sciences, 4th floor emergency building, anaesthesia and critical care, jodhpur Jodhpur RAJASTHAN |
9829159665
pk_bhatia@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, AIIMS jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients (above 18 years), ASA Physical Status I-III, undergoing RALS in steep Trendelenburg position or laparotomy of estimated duration more than 4 hours
|
|
| ExclusionCriteria |
| Details |
Age less than 18 years
Diaphragmatic hernia, ascites,stroke,pregnancy
Known case of neuromuscular disorder
Phrenic nerve injury
Post op mechanical ventilation
Not giving consent
Neuromuscular transmission monitoring not possible |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
For improvement in medical sciences
The most probable outcome from this study is decrease in diaphragm function post RALS due to steep Trendelenburg and this in future could help in risk stratification in these patients
|
post operatively after half an hour of procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
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)
|
01/01/2025 |
| 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="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patient will be assessed preoperatively before induction using a GE Healthcare ultrasound (M-mode) to examine the DE and TF of both hemidiaphragms respectively in a semi recumbent position with the head of the bed tilted at 45 degrees. The diaphragm excursion refers to the movement of diaphragm during breathing assessed by ultrasound by placing a linear probe over the lower intercostals space in the anterior axillary line measured during a quiet breathing. The ultrasound beam was directed to the diaphragm domes at an angle greater than 70 degrees and M-mode tracing was initiated. DE is measured as the vertical distance from the baseline to the highest point of inspiration at quiet breathing. Six measurements from both the hemidiaphragms will be obtained and their mean will be used in data analysis. Where as The diaphragm thickness is measured (in the zone of apposition of the diaphragm and rib cage) in the mid-axiallary line (longitudinally) between the eighth and tenth intercostals space, using a high frequency linear probe. the diaphragm will be viewed as a three layered structure sandwiched between the two ecogenic layer of pleura and peritoneum. Using the M-mode function, the thickness of the diaphragm at end inspiration (DTI) and end expiration (DTE) will be measured. TF is given by the formula: TF = DTI – DTE / DTE * 100 TF of both the hemidiaphragm was taken into account and there mean was used for data analysis. Intra-operative neuromuscular monitoring with NMT for TOF ratio will be monitored and only when TOF >0.9 patient will be extubated so as no neuromuscular residual blockade persist due to general anaesthesia.
Post operatively patient will be examined in PACU after one hour of successful extubation and same technique will be used as described above for post operative DE and TF measurement and their findings will be compared and analyzed for any residual paralysis or dysfunction of diaphragm post RALS and laparotomies. |