| CTRI Number |
CTRI/2019/08/021005 [Registered on: 30/08/2019] Trial Registered Prospectively |
| Last Modified On: |
29/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
alteration in post op PFT and its relationship with BMI
|
|
Scientific Title of Study
|
correlation of post operative pulmonary function tests with body mass index in patiens undergoing elective surgeries under general anaesthesia |
| Trial Acronym |
post op PFT and BMI |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Radhika Agarwala |
| Designation |
Director Professor |
| Affiliation |
LADY HARDINGE MEDICAL COLLEGE AND ASSOSCIATED HOSPITALS |
| Address |
Department of Anaesthesiology
Lady Hardinge Medical college
New Delhi
C604
Shaheed Bhagat Singh Road
DIZ Area
Connaught Place
New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9811702063 |
| Fax |
|
| Email |
radhikaagarwala@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Radhika Agarwala |
| Designation |
Director Professor |
| Affiliation |
LADY HARDINGE MEDICAL COLLEGE AND ASSOSCIATED HOSPITALS |
| Address |
Department of Anaesthesiology
Lady Hardinge Medical college
New Delhi
C604
Shaheed Bhagat Singh Road
DIZ Area
Connaught Place
New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9811702063 |
| Fax |
|
| Email |
radhikaagarwala@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr NEETHU P P |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
LADY HARDINGE MEDICAL COLLEGE AND ASSOSCIATED HOSPITALS |
| Address |
Department of Anaesthesiology
Lady Hardinge Medical college
New Delhi
C604
Shaheed Bhagat Singh Road
DIZ Area
Connaught Place
New Delhi
New Delhi
DELHI
110001
India |
| Phone |
7034124409 |
| Fax |
|
| Email |
neethuorkkatteri@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Lady Hardinge Medical College and Associated Hospitals |
| Address |
C 604
Shaheed Bhagat Singh Road
DIZ Area
Connaught Place
New Delhi |
| Type of Sponsor |
Government medical college |
|
|
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 NEETHU P P |
Department of Anaesthesiology |
Lady Hardinge Medical College and Associated Hospitals
C 604
Shaheed Bhagat Singh Road
DIZ Area
Connaught Place
New Delhi
New Delhi
DELHI |
7034124409
neethuorkkatteri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE FOR HUMAN RESEARCH LADY HARDINGE MEDICAL COLLEGE &ASSOCIATED HOSPITALS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R69||Illness, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA GRADE 1&2
PATIENTS POSTED FOR ELECTIVE SURGERY UNDER GENERAL ANAESTHESIA |
|
| ExclusionCriteria |
| Details |
PATIENT REFUSAL
OBSTETRIC PATIENTS
PATIENTS WITH PRE EXISTING PULMONARY DISEASES |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| PROPORTION OF PATIENTS WITH ALTERATION OF PULMONARY FUNCTION TESTS AND CORRELATION WITH BMI |
BASE LINE AND AFTER 24 HOUR |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| CORRELATION OF ALTERATION IN PFT WITH PATIENTS CHARACTERISTICS LIKE AGE AND GENDER |
BASE LINE AND AFTER 24 HR |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
31/08/2019 |
| 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 prevalance of obesity has increased wordwide in both develoed and developing countries.Obesity has shown to negatively impact the respiratory system and pulmonary function.It has been widely reported thet obesity can lead to restrictive pulmonary disease.Several studies have been done to asess the alteration in pulmonary function tests in post operative period. In the present day surgical practise early discharge after surgery is very common . With increasing prevalence of obesity and with increase incidence of surgical interventions in obese patients, there is lack of adequate assessment of alteration of pulmonary function in post operative period in obese patients.Thus the present study will be undertaken to study the alteration in pulmonary function tests in patients undergoing elective surgery under general anaesthesia and its relation with body mass index After a detailed pre anaesthetic evaluation patients scheduled for surgery under GA satisfying the inclusion criteria will be taken for study.Written and informed consent will be obtained after explaining the procedure in a language that the patient understand one day before the surgery.Patients height,weight,age,gender will be noted.Baseline PFT values will be recorded by using UNI EM SPIROMIN VERSION 17 02. Patient will also informed that a similar test will be performed after 24 hrs after surgery. Patient will receive standard general anaesthesia. Hemodynamic parameters like SBP,DBP and HR and EtCO2 and SPO2 and ECG will be monitored.Total duration of anaesthesia will be noted. Patient will be shifted to post operative ward for monitoring after recovery from anaesthesia |