| CTRI Number |
CTRI/2025/10/095606 [Registered on: 06/10/2025] Trial Registered Prospectively |
| Last Modified On: |
05/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of desaturation time and oxygenation time with two different oxygen concentrations using percentage of oxygen in the last part of exhaled breath in patients undergoing oncological surgeries |
|
Scientific Title of Study
|
Comparison of apnea time and preoxygenation time with two different oxygen concentrations using end tidal oxygen concentration in patients undergoing oncological surgeries a prospective randomised 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 |
Dr Priya H S |
| Designation |
Junior Resident |
| Affiliation |
Kidwai memorial institute of oncology |
| Address |
Room no 105 OT complex building
Department of Anaesthesiology and Pain Relief
Kidwai memorial institute of oncology Dr MH MARIGOWDA road
Bangalore
KARNATAKA
560029
India |
| Phone |
9481223896 |
| Fax |
|
| Email |
drpriyahs2710@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Namrata Ranganath |
| Designation |
Professor |
| Affiliation |
Kidwai memorial institute of oncology |
| Address |
Room no 105 OT complex building Department of Anaesthesiology and Pain Relief
Kidwai memorial institute of oncology
Bangalore
KARNATAKA
560085
India |
| Phone |
9880642830 |
| Fax |
|
| Email |
namrang@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Namratha G C |
| Designation |
Associate Professor |
| Affiliation |
Kidwai memorial institute of oncology |
| Address |
Room no 105 OT complex building Department of Anaesthesiology and Pain Relief
kidwai memorial institute of oncology
Bangalore
KARNATAKA
560029
India |
| Phone |
7760771417 |
| Fax |
|
| Email |
namrang@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kidwai memorial institute of oncology DrM H Marigowda road hombegowda nagar Bengaluru India 560029 |
|
|
Primary Sponsor
|
| Name |
Kidwai memorial institute of oncology |
| Address |
Dr MH Marigowda road hombegowda nagar Bengaluru 560029 |
| Type of Sponsor |
Other [Government 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 |
| Dr Priya H S |
Kidwai memorial institute of oncology |
Kidwai memorial institute of oncology
Room no 105 OT complex building
Department of Anaesthesiology and Pain Relief
Dr MH Marigowda road hombegowda nagar Bengaluru
Bangalore
KARNATAKA |
9481223896
drpriyahs2710@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medical Ethics Committee Kidwai memorial institute of oncology |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C801||Malignant (primary) neoplasm, unspecified, (2) ICD-10 Condition: C41||Malignant neoplasm of bone and articular cartilage of other and unspecified sites, (3) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (4) ICD-10 Condition: C499||Malignant neoplasm of connective and soft tissue, unspecified, (5) ICD-10 Condition: C57||Malignant neoplasm of other and unspecified female genital organs, (6) ICD-10 Condition: C63||Malignant neoplasm of other and unspecified male genital organs, (7) ICD-10 Condition: C15-C26||Malignant neoplasms of digestive organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to ASA physical status grade I and II |
|
| ExclusionCriteria |
| Details |
Patients above 65years of age
Patients with anticipated difficult mask ventilation
Patients with obesity
Patients with lung diseases
Patients with cardiac diseases
Patients with raised ICP |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare apnea time between 100 and 80 FiO2 groups
To compare preoxygenation time between 100 and 80 FiO2 groups |
At 3 minutes
At 10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe changes in hemodynamic parameters during preoxygenation & apnea time |
At baseline
After 3 minutes
After 5 minutes
After 6 minutes
After 10 minutes
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/11/2025 |
| 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="2"
Months="0"
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
|
Patients will be divided into 2 groups group 100 and group 80 Group 100 will be preoxygenated with 100 percent FiO2 and time taken for ETO2 to reach 90 percent is noted and group 80 will be preoxygenated with 80 percent FiO2 and time taken for ETO2 to reach 70 percent is noted as preoxygenation time then after inducing with propofol and muscle relaxation with rocuronium bag and mask ventilation will be done by putting patient on ventilator for 3 minutes then after intubation position of endotracheal tube is confirmed with chest raise single trace of ETCo2 after the delivery of 400ml of one tidal volume breath and circuit is disconnected to look for desaturation time for up to 95 percent and this time will be noted as apnea time once saturation drops to 95 percent circuit is connected back and patient will be ventilated till saturation increases to 100 percent Preoxygenation time and apnea time in both the groups are compared |