| CTRI Number |
CTRI/2024/08/072421 [Registered on: 13/08/2024] Trial Registered Prospectively |
| Last Modified On: |
12/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Using blood test namely arterial blood gas to predict successful removal of breathing tubes in high risk gynaecological surgery |
|
Scientific Title of Study
|
Evaluation of Arterial Blood Gas as a predictor of successful tracheal extubation of patients undergoing high risk elective gynaecological surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shreya Sharma |
| Designation |
Post Graduate Resident |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Ground floor, Main Operation theatre building, Safdarjung Hospital Campus, Ansari Nagar East, New Delhi
South West
DELHI
110029
India |
| Phone |
8604035079 |
| Fax |
|
| Email |
sharmazeiney2001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nishtha Kachru |
| Designation |
Associate Professor |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Ground floor, Main Operation theatre building, Safdarjung Hospital Campus, Ansari Nagar East, New Delhi
South West
DELHI
110029
India |
| Phone |
9958844229 |
| Fax |
|
| Email |
kachnishtha98@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nishtha Kachru |
| Designation |
Associate Professor |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Ground floor, Main Operation theatre building, Safdarjung Hospital Campus, Ansari Nagar East, New Delhi
DELHI
110029
India |
| Phone |
9958844229 |
| Fax |
|
| Email |
kachnishtha98@gmail.com |
|
|
Source of Monetary or Material Support
|
| VMMC and Safdarjung Hospital
Safdarjung Hospital Campus, Ansari Nagar East, New Delhi,Delhi 110029 |
|
|
Primary Sponsor
|
| Name |
VMMC and Safdarjung Hospital |
| Address |
Safdarjung Hospital Campus, Ansari Nagar East, New Delhi, 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 Shreya Sharma |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Department of Anaesthesia and Intensive care, Ground Floor, Main Operation theatre building, Safdarjung Hospital campus, Ansari Nagar East, New Delhi
South West
DELHI |
8604035079
sharmazeiney2001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
It is an observational study |
It is an observational sudy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
Female patients aged above 18 years planned for elective gynaecological oncological surgery under general anaesthesia requiring endotracheal intubation |
|
| ExclusionCriteria |
| Details |
1.Known case of Chronic kidney disease, Chronic obstructive pulmonary disease, Renal tubular acidosis, polytrauma
2. Pregnancy
3. Severe sepsis and septic shock |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess partial pressure of oxygen in intraoperative arterial blood gas sample as a predictor of successful tracheal extubation in patients undergoing high risk elective gynaecological surgery |
Arterial blood gas sample will be taken 10 minutes before tracheal extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess partial pressure of Carbon dioxide, bicarbonate level & pH in intraoperative arterial blood gas sample as a predictor of successful tracheal extubation in patients undergoing high risk elective gynaecological surgery |
Arterial blood gas sample will be taken 10 minutes before tracheal extubation |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
31/08/2024 |
| 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
|
Extubation in high risk surgeries involves many factors including ventilation, oxygenation, hemodynamics, fluid status and blood loss. Extubation carries a risk of reintubation. A comprehensive tool is needed to assess these factors and Arterial Blood Gas i.e ABG is one such tool. Extubation criteria used in OT focusses on subjective measures like head raising, following commands and verbal response which can be unreliable. ABG offers a more objective assessment, potentially improving extubation decisions in high risk surgeries. While ABG analysis is widely used to make extubation decisions in ICU settings, there is limited data on their use in OT settings. Patients planned for high risk elective gynaecological surgery will be recruited in the study according to inclusion and exclusion criteria after taking written informed consent. Patient will be taken to OT, general anaesthesia will be given and airway will be secured by an appropriate size cuffed endotracheal tube and standard anaesthesia protocol will be followed. Intraoperative hemodynamic parameters will be monitored and ABGs will be done as per patient requirement. ABG taken just before extubation will be analysed in the study for parameters like PaO2, PaCO2, pH and Bicarbonate levels. Following fulfillment of standard extubation criteria according to departmental anaesthesia protocol, patient will be extubated and followed up for 24 hours post operatively to look for any reintubation. Those not meeting extubation criteria and sent to ICU will also be observed for 24 hours. ABG values will be compared between patients who are successfully extubated in OT with those reintubated within 24 hours postoperatively. |