| CTRI Number |
CTRI/2026/02/103308 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
08/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of different oxygen delivery methods during a lung biopsy procedure using endoscopy |
|
Scientific Title of Study
|
Comparative study of conventional oxygen therapy and graded high flow nasal cannula oxygenation during conscious sedation EBUS-TBNA: A Randomized Controlled Trial” (OXY-EBUS Trial) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr VIJAY HADDA |
| Designation |
Professor |
| Affiliation |
AIIMS |
| Address |
Department of pulmonary, critical care and sleep medicine, AIIMS Delhi New Delhi New Delhi DELHI 110029 India |
| Phone |
9868883208 |
| Fax |
|
| Email |
vijayhadda@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
VENKAT RAJ G |
| Designation |
Senior Resident |
| Affiliation |
AIIMS |
| Address |
Department of pulmonary, critical care and sleep medicine, AIIMS Delhi New Delhi New Delhi DELHI 110029 India |
| Phone |
8973448299 |
| Fax |
|
| Email |
gvenkatraj1996@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
VENKAT RAJ G |
| Designation |
Senior Resident |
| Affiliation |
AIIMS |
| Address |
Department of pulmonary, critical care and sleep medicine, AIIMS Delhi New Delhi
DELHI 110029 India |
| Phone |
8973448299 |
| Fax |
|
| Email |
gvenkatraj1996@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
Ansari Nagar, New Delhi - 110029 |
| 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 |
| Dr VIJAY HADDA |
AIIMS |
Department of Pulmonary, critical care and sleep Medicine, AIIMS, Ansari Nagar, New Delhi - 110029 New Delhi DELHI |
9868883208
vijayhadda@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Institutional Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J988||Other specified respiratory disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional oxygen therapy |
By using nasal prongs, started with 1L/min increasing gradually |
| Intervention |
High flow nasal oxygen |
Divided into 4 arms-
Arm 1 - 40%, 30L
Arm 2 - 100%, 30L
Arm 3 - 40%, 50L
Arm 4 - 100%, 50L |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Adults more than 18 years scheduled for diagnostic EBUS-TBNA under conscious sedation.
2.Able to consent/willing to participate. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Desaturation events |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of desaturation events |
During procedure |
| Pre and post procedure pCo2 levels (blood gas analysis |
Pre and post procedure |
Patient comfort assessed on visual analogue scale (0-extreme discomfort, 100-very comfortable)
Bronchoscopist satisfaction assessed on visual analogue scale (0-unsatisfied, 100-very satisfied) |
Post procedure |
| Post procedure nasal dryness or discomfort (0-severe dryness, 100-no dryness) |
Post procedure |
|
|
Target Sample Size
|
Total Sample Size="380" Sample Size from India="380"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
19/02/2026 |
| 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 Applicable |
| 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
|
Endobronchial ultrasound-guided procedures performed under conscious sedation are increasingly used for the diagnosis and staging of mediastinal and pulmonary diseases. These procedures are often prolonged and are associated with a significant risk of hypoxemia due to sedation-related respiratory depression, partial airway obstruction by the bronchoscope, and underlying respiratory comorbidities. Maintenance of adequate oxygenation during EBUS under conscious sedation is therefore a critical component of procedural safety.
Conventional oxygen therapy is commonly employed during EBUS; however, it may be inadequate to prevent desaturation, particularly during periods of apnea or hypoventilation. High-flow nasal oxygen therapy has emerged as an alternative oxygen delivery strategy, offering higher flow rates, more stable inspired oxygen concentrations, and a potential reduction in hypoxemic episodes. Despite its increasing use, there is limited comparative evidence regarding the optimal oxygen delivery method, flow rate, and oxygen concentration during EBUS procedures performed under conscious sedation.
The purpose of this study is to compare different oxygen delivery strategies, including conventional oxygen therapy and various high-flow nasal oxygen modalities, during EBUS under conscious sedation, with respect to their ability to maintain adequate oxygenation and reduce peri-procedural hypoxemic events |