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
|
|
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
|
|
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. |