| CTRI Number |
CTRI/2025/06/088648 [Registered on: 11/06/2025] Trial Registered Prospectively |
| Last Modified On: |
10/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing two oxygen delivery devices to improve the patient safety and improve performance of EBUS procedures |
|
Scientific Title of Study
|
Comparison of oxygenation through nasal airway to that through nasal prongs in patients undergoing intravenous anaesthesia for EBUS procedures. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ankita |
| Designation |
DNB Resident |
| Affiliation |
Indraprastha apollo hospital, New Delhi |
| Address |
Anesthesiology department, 1st floor, indraprastha apollo hospital ,New Delhi, 110076, India
South
DELHI
11076
India |
| Phone |
9582590674 |
| Fax |
|
| Email |
ankitamehandiratta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Shankar |
| Designation |
Consultant |
| Affiliation |
Indraprastha apollo hospital, New Delhi |
| Address |
Anesthesiology department, 1st floor, indraprastha apollo hospital ,New Delhi, 110076, India
South
DELHI
11076
India |
| Phone |
8130556353 |
| Fax |
|
| Email |
vijaysnair95@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ankita |
| Designation |
DNB Resident |
| Affiliation |
Indraprastha apollo hospital, New Delhi |
| Address |
Anesthesiology department, 1st floor, indraprastha apollo hospital ,New Delhi, 110076, India
South
DELHI
11076
India |
| Phone |
9582590674 |
| Fax |
|
| Email |
ankitamehandiratta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indraprastha apollo hospital, sarita vihar, new delhi, 110076, India |
|
|
Primary Sponsor
|
| Name |
Dr Ankita |
| Address |
Anesthesiology department, 1st floor, indraprastha pollo hospital, Sarita Vihar, New Delhi, 110076, India |
| Type of Sponsor |
Other [Self] |
|
|
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 Ankita |
Indraprastha Apollo Hospital, Sarita Vihar , New Delhi |
1st floor, anaesthesiology department, Indraprastha Apollo hospital, Sarita Vihar, New Delhi 110076
South
DELHI |
9582590674
ankitamehandiratta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, biomedical research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J958||Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nasal airway |
Oxygen will be provided through nasal airway in patients undergoing intravenous anesthesia for EBUS procedures for around 40 minutes |
| Comparator Agent |
Nasal prongs |
Oxygenation will be provided through nasal prongs and it will be compared for around 40 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Able to give informed consent, spontaneously breathe throughout procedure, no history of cardiorespiratory or hepatic failure, baseline saturation more than 90% |
|
| ExclusionCriteria |
| Details |
Age more than 80years, chronic hypoxemic, nasal bone fracture, uncorrectable coagulopathy, pregnant, arrythmias history, bmi more than 30, previous nasal surgery, cardiorespiratory or hepatic failure |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Desaturation events |
10 minutes in recovery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Procedural desaturation, interruptions and duration, coughing, nasal bleed and patients comfort |
10 mins in recovery |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
30/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/06/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
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
|
In this study, we intend to evaluate the efficacy and effectiveness of oxygenation through nasal airway and compare it to nasal prongs in patients undergoing endobronchial ultrasound guided procedures. We will compare two devices in terms of complications, procedural interruptions, and duration. We will also compare patients comfort with both devices. We hope the findings of our study will significantly improve patient safety and ease of performance of procedure |