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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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