FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/03/063406 [Registered on: 01/03/2024] Trial Registered Prospectively
Last Modified On: 29/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Oxygen supplementation for a procedure]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of three techniques of giving oxygen during flexible bronchoscopy in children 
Scientific Title of Study   Comparison of three methods of oxygen supplementation during flexible bronchoscopy in children: A randomized controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Maaz Ahmed 
Designation  DM student Peds Pulmo and Intensive care 
Affiliation  AIIMS NEW DELHI 
Address  Department of Pediatrics, AIIMS, New Delhi

South
DELHI
110029
India 
Phone  9902478708  
Fax    
Email  maazindian@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kana Ram Jat 
Designation  Additional Professor 
Affiliation  AIIMS New Delhi 
Address  Department of Pediatrics, AIIMS, New Delhi

South
DELHI
110029
India 
Phone  9868152426  
Fax    
Email  drkanaram@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kana Ram Jat 
Designation  Additional Professor 
Affiliation  AIIMS New Delhi 
Address  Department of Pediatrics, AIIMS, New Delhi


DELHI
110029
India 
Phone  9868152426  
Fax    
Email  drkanaram@gmail.com  
 
Source of Monetary or Material Support  
AIIMS, NEW DELHI 
 
Primary Sponsor  
Name  AIIMS NEW DELHI 
Address  ANSARI NAGAR, NEW DELHI 
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 
Maaz Ahmed  AIIMS New Delhi  Bronchoscopy Suite, Day care ,Department of Pediatrics, AIIMS, New Delhi
South
DELHI 		 9902478708

maazindian@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics 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 
Intervention  Intervention 1: Oxygen supplementation through high flow nasal cannula (HFNC)  The total duration of the procedure will be 10 to 20 minutes. The preparation of the child will be done over 30 minutes, and the child will be observed and monitored for 2 hours post procedure. We will use the device AirvoTM 2 high flow system by Fisher and Paykel Healthcare. The Nasal cannula will be selected as per appropriate sized Opti flow cannula. The initial oxygen flow will be 1 L / kg/min (maximum flow 25L/min for pediatric size and 40 L/min for adult size cannula) and the target saturation will be set at SpO2 94 %. Subsequent increments in flow up to 2L/kg (maximum flow 25L/min for pediatric size and 40 l/min for adult size cannula) will be done if saturations fall below 94 %. The FiO2 will be set at 1 at the beginning of the procedure. The flexible bronchoscope will be introduced via nasal route and if one side of the prong will be blocked, then it will be moved out from this nare. If in case of desaturation is sustained i.e. SpO2 85% or bradycardia (60 beats/min) that lasted more than 5 seconds, the procedure will be interrupted and bag and mask ventilation will be performed. 
Intervention  Intervention 2: Oxygen supplementation modified nasopharyngeal catheter insufflation.   The total duration of the procedure will be 10 to 20 minutes. The preparation of the child will be done over 30 minutes, and the child will be observed and monitored for 2 hours post procedure. In this group humidified heated oxygen using MR 730 servo-controlled heated respiratory humidifier will be provided by inserting a suction catheter into nasopharynx. The modified nasopharyngeal catheter will be set up with help of checklist in the appendix 7. The Suction catheter sizes of 6F to 10 F will be selected as per weight as a nasopharyngeal catheter as summarized in table 4. The nasopharyngeal catheter will be inserted via one nostril (preferably left side). The length of insertion will be estimated as 1cm less than the distance from the nostril to the same-side ear lobe. The catheter outside the nose will be secured. The ideal tip location should be free in the nasopharynx or oropharynx, should not be embedding the mucosa. A constant flow of oxygen which is warmed and humidified via a humidifier will be delivered. Flow rates used will be 0.5 L/kg, maximum up to 10 L. The rates of oxygen flow that will be set via modified nasopharyngeal catheter insufflation as described in table 5. During the procedure, if there will be any SpO2 85%, or bradycardia (60 beats/min) that lasted more than 5 seconds, the scope will be removed immediately, and Soong’s ventilation will be given by pinching nose and mouth for 2-3 seconds for inspiration and pressing abdomen after releasing nose and mouth for expiration. If not improving with Soong’s ventilation, then bag and mask ventilation will be used.  
Comparator Agent  Oxygen supplementation via nasal cannula  The total duration of the procedure will be 10 to 20 minutes. The preparation of the child will be done over 30 minutes, and the child will be observed and monitored for 2 hours post procedure.Supplemental oxygen during the bronchoscopy procedure will be given by a traditional nasal cannula with double prongs which will be inserted into the child’s nostrils and then it’s secured over the face. The sizes infant or pediatric will be selected as per the age of the child. Bronchoscopy will be done through nasal route. The oxygen flow rate will be 2-4 L/min. If there will be difficulty in passing scope along the cannula, one cannula will be cut and cut end will be put at opening of nostril and bronchoscopy will be done through another nostril. If desaturation is sustained i.e. SpO2 85% or bradycardia (60 beats/min) that lasts more than 5 seconds, the procedure will be interrupted, and bag and mask ventilation will be performed. . If possible, we may change the technique to HFNC or nasopharyngeal catheter in case of failure of nasal cannula. 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  15.00 Year(s)
Gender  Both 
Details  1. Children 1 month – 15 years of age.
2. Undergoing elective flexible bronchoscopy examination for any indication
 
 
ExclusionCriteria 
Details  1. The need for pre‐flexible bronchoscopy HFNC, noninvasive ventilation (NIV), or invasive mechanical ventilation (IMV)
2. Flexible bronchoscopy being performed as an emergency procedure.
3. Children on tracheostomy
4. Children with cyanotic heart disease
5. Children undergoing flexible bronchoscopy for endobronchial interventions apart from bronchoscopy and BAL.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Incidence of desaturations in children undergoing Flexible bronchoscopy while supplementing oxygen with modified nasopharyngeal insufflation and HFNC compared to nasal cannula in the age group of one month to fifteen years  Saturation thirty minutes prior to procedure, saturation continuous monitoring during procedure, every 15 minute post procedure for two hours  
 
Secondary Outcome  
Outcome  TimePoints 
Proportion of patients with desaturation less than Ninety percent   Saturation thirty minutes prior to procedure, saturation continuous monitoring during procedure, every 15 minute post procedure for two hours  
Number of patients requiring assisted breathing by bag & mask or Soong’s ventilation  saturation continuous monitoring during procedure, every 15 minute post procedure for two hours . Number of patients requiring assisted breathing, If oxygen saturation less than eighty five percentage, or bradycardia, less than beats per min) for more than five seconds, the bronchoscopy will be interrupted & assisted ventilation will be started  
Number of procedure interruptions or abandonment  during procedure, every 15 minute post procedure for two hours  
The lowest oxygen saturation during the procedure.  saturation continuous monitoring during procedure, every 15 minute post procedure for two hours  
The total duration of desaturations to less than Ninety percent & less than Ninety four percent  Continuous monitoring during procedure, every 15 minute post procedure for two hours  
Heart rate during the procedure  Saturation thirty minutes continuous monitoring during procedure, every 15 minute post procedure for two hours  
Adverse events associated with the procedure, Major - post procedure oxygen requirement, intubation & mechanical ventilation, mortality, minor- nasopharyngeal bleeding or fever  continuous monitoring during procedure, every 15 minute post procedure for two hours  
 
Target Sample Size   Total Sample Size="177"
Sample Size from India="177" 
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)   11/03/2024 
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="1"
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  

There is paucity of data on appropriate method of oxygen supplementation in children undergoing flexible bronchoscopy. HFNC is found to be superior compared to oxygen supplementation by nasal prongs in one pediatric trial, but it requires commercial equipment with ongoing cost. Oxygen supplementation by nasopharyngeal catheter using HFNC device is found to be useful, but its use without standard HFNC device has not been studied. We plan to compare three techniques of oxygen supplementation namely nasal cannula, HFNC, and modified nasopharyngeal catheter without HFNC device during flexible bronchoscopy in children. This study will help in optimizing the management of children undergoing flexible bronchoscopy without significant cost.

 
Close