| CTRI Number |
CTRI/2025/10/096418 [Registered on: 23/10/2025] Trial Registered Prospectively |
| Last Modified On: |
22/10/2025 |
| 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
|
Better Breathing Support During Bronchoscopy with Bronchoalveolar lavage: High-Flow Oxygen vs Regular Oxygen. |
|
Scientific Title of Study
|
A Comparative Study on Efficacy of High Flow Nasal Cannula Oxygen Therapy versus Conventional Oxygen Therapy in Patients Undergoing Bronchoscopy for Bronchoalveolar Lavage : A Randomized Control Trial |
| Trial Acronym |
AIR-BRONCHO TRIAL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
G SARIGA |
| Designation |
POSTGRADUATE, MD RESPIRATORY MEDICINE |
| Affiliation |
Pondicherry institute of medical sciences |
| Address |
Pondicherry Institute of Medical Sciences, Village No 20., Kalathumettupathai, Ganapathichettikulam, Kalapet, Puducherry
Pondicherry
PONDICHERRY
605014
India |
| Phone |
8220851300 |
| Fax |
|
| Email |
drsariga17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ARUN PRASATH |
| Designation |
MD RESPIRATORY MEDICINE |
| Affiliation |
Pondicherry institute of medical sciences |
| Address |
Pondicherry Institute of Medical Sciences, Village No 20., Kalathumettupathai, Ganapathichettikulam, Kalapet, Puducherry
Pondicherry
PONDICHERRY
605014
India |
| Phone |
8940049836 |
| Fax |
|
| Email |
aprasath1990@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
G SARIGA |
| Designation |
POSTGRADUATE, MD RESPIRATORY MEDICINE |
| Affiliation |
Pondicherry institute of medical sciences |
| Address |
Pondicherry Institute of Medical Sciences, Village No 20., Kalathumettupathai, Ganapathichettikulam, Kalapet, Puducherry
Pondicherry
PONDICHERRY
605014
India |
| Phone |
8220851300 |
| Fax |
|
| Email |
drsariga17@gmail.com |
|
|
Source of Monetary or Material Support
|
| PONDICHERRY INSTITUTE OF MEDICAL SCIENCE |
|
|
Primary Sponsor
|
| Name |
Pondicherry Institute of Medical sciences. |
| Address |
Pondicherry Institute of Medical science, Kalathumettupathai, Ganapathichettikulam, Village 20 , Puducherry 605014. |
| Type of Sponsor |
Private 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 SARIGA G |
Pondicherry Institute of Medical sciences |
Department of Respiratory medicine, Village 20, kalathumatupathai, Ganapathichettikulam, Kalapet, Puducherry, 605014, Pondicherry.
Pondicherry
PONDICHERRY |
8220851300
drsariga17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIMS institute of Ethics commitee |
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 |
| Comparator Agent |
Conventional oxygen therapy |
Patient will be connected to Conventional oxygen therapy during procedure via nasal cannula |
| Intervention |
High flow oxygen therapy |
Patient will be connected to High flow oxygen therapy support during bronchoscopy procedure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All patients age 18 years and above with indications of bronchoscopy for bronchoalveolar lavage |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the episode of incidence of hypoxia (Spo-90%), between HFNC and COT during bronchoscopy with bronchoalveolar lavage. |
Pre procedural (Baseline)
Room air Saturation, Heart Rate.
During procedure-At bronchoscopy insertion, mid-procedure(every 5 minutes), at maximum point of saturation if any
At completion of bronchoscopy.
Immediate Post procedure
Early recovery - 30 mins after procedure.
1 hour post procedure
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the patient comfort and tolerance levels between two group , to compare the rate of procedure interruptions due to desaturation, to analyze the post bronchoscopy complications in both group. |
It is assessed from the start of procedure to 24 hours post procedure. |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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)
|
11/11/2025 |
| 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 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
|
After obtaining ethical committee clearance of Pondicherry Institute of Medical Sciences, study will be done. It is randomized control study with study population of 102 participants. After obtaining informed and written consent patient will be randomized into two groups by computer generated randomization. Group A, procedure will be done with Convention oxygen therapy with nasal cannula with 1-15l/min , and titrated according to saturation. Group B, HFNC will be used and patient oxygen flow rate and FiO 2 will be tapered according to the saturation. Both group vitals , Saturation, heart rate, respiratory rate, blood pressure will be monitored pre, inter and post procedure. And patient tolerance, comfort and post procedure adverse events will be monitored for 24 hours post procedure. Any episodes of desaturated , frequency of interupptions, post procedure complications will be monitored. |