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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  
AIIMS, NEW DELHI 
 
Primary Sponsor  
Name  AIIMS 
Address  Ansari Nagar, New Delhi - 110029 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 
Details   
 
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
 
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