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CTRI Number  CTRI/2019/02/017881 [Registered on: 28/02/2019] Trial Registered Prospectively
Last Modified On: 22/02/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Non-randomized, Placebo Controlled Trial 
Public Title of Study   Measurement of breathing muscle movement using ultrasound before abdominal surgery 
Scientific Title of Study   Preoperative ultrasound assessment of diaphragmatic function in patients with perforation peritonitis – A cross sectional comparative study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Stalin Vinayagam 
Designation  Associate Professor, Department of Anaesthesiology and Critical Care 
Affiliation  JIPMER 
Address  2nd floor,Institute block,JIPMER campus, Dhanvantri nagar, Puducherry-6
2nd floor,Institute block,JIPMER campus, Dhanvantri nagar, Puducherry-6
Pondicherry
PONDICHERRY
605006
India 
Phone    
Fax    
Email  drvstalin@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Stalin Vinayagam 
Designation  Associate Professor, Department of anaesthesiology and Critical Care 
Affiliation  JIPMER 
Address  2nd floor,Institute block,JIPMER campus, Dhanvantri nagar, Puducherry-6
2nd floor,Institute block,JIPMER campus, Dhanvantri nagar, Puducherry-6
Pondicherry
PONDICHERRY
605006
India 
Phone    
Fax    
Email  drvstalin@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Jayaram I 
Designation  Junior Resident, Department of Anaesthesiology 
Affiliation  JIPMER 
Address  2nd floor,Institute block,JIPMER campus, Dhanvantri nagar, Puducherry-6
2nd floor,Institute block,JIPMER campus, Dhanvantri nagar, Puducherry-6
Pondicherry
PONDICHERRY
605006
India 
Phone  9498874256  
Fax    
Email  i.jayaram11@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Nehru Institute of Postgraduate Medical Education and Research, Dhanvantri Nagar, Puduchery-605006 
 
Primary Sponsor  
Name  JIPMER 
Address  Dhanvantri nagar, Puducherry-6 
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 
Jayaram I  JIPMER  Department of Anaesthesiology, 2nd floor, Institute block, Jipmer campus, Dhanvantri nagar, Puducherry-6
Pondicherry
PONDICHERRY 
9498874256

i.jayaram11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JIPMER INSTITUTIONAL ETHICS COMMITTEE HUMAN STUDIES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K650||Generalized (acute) peritonitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group C  Patients scheduled for elective laparotomy under general anaesthesia 
Intervention  Group P  Patients with perforation peritonitis scheduled for emergency laparotomy under general anaesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients with perforation peritonitis scheduled for emergency laparotomy under general anaesthesia
2.Age 18-60 yrs.
3.American society of Anaesthesiologists(ASA) classification 1 – 3 patients
 
 
ExclusionCriteria 
Details  1.History of neuromuscular disease
2.Pneumothorax or pneumomediastinum
3.Intubated patients
4.Patients with pre-existing pulmonary disease
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To measure diaphragmatic excursion using preoperative ultrasound   Before Induction of Anaesthesia 
 
Secondary Outcome  
Outcome  TimePoints 
To measure diaphragmatic thickness using preoperative ultrasound  Before Induction of Anaesthesia 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   01/05/2019 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

After obtaining approval from Postgraduate research monitoring committee (PGRMC), Institute ethics committee, and completing CTRI registration, patients satisfying eligibility criteria will be selected by consecutive sampling technique. Written informed consent explaining about the procedure, risks and any adverse events will be obtained before being enrolled into the study.

            The attending anesthesiologist will do a thorough preoperative assessment and history on duration of illness will be obtained. Patients will be shifted in to the OT table and all standard monitors will be attached and baseline parameters will be recorded.(PR, SBP, ECG). Pulmonary function test will be performed using a bedside spirometer and the parameters like Tidal volume(TV), Vital capacity(VC), forced vital capacity(FVC), forced expiratory volume (FEV1) and peak expiratory flow rate (PEFR) will be recorded in supine position. An experienced anaesthesiologist will visualize the diaphragm using a curvilinear probe of high resolution portable ultrasound machine. In 2- dimensional mode, the probe will be placed on the right anterior axillary lines at the level of 8th to 10th intercostal space to achieve the best view of the hemidiaphragm. Patient will be asked to take deep inspiration and the movement of the hemidiaphragm will be recorded on M-mode sonography at zone of opposition. During M-mode imaging, the normally functioning diaphragm is represented as an echogenic line that moves freely during inspiration and expiration. Inspiration is identified on the sonographic tracing as an upward flexion and expiration will be identified as downward flexion.

 

             Diaphragmatic excursion will be measured by the vertical distance between the upward flexion at the end of inspiration and downward flexion at the end of expiration ie, the vertical distance between the bottom and the peak of the tracing line; This vertical distance represents diaphragmatic excursion. Diaphragm thickness will be estimated as the vertical distance between the pleural and peritoneal layers at the end of expiration. Parameters like repiratory rate, arterial blood gas analysis(ABG) and abdominal girth will be measured before induction. General anaesthesia will be induced as per departmental protocol. At the end of the surgery, duration of surgery and whether patient was extubated or not will be noted. If not extubated, duration of mechanical ventilation will be noted.

 
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