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CTRI Number  CTRI/2023/08/056107 [Registered on: 03/08/2023] Trial Registered Prospectively
Last Modified On: 26/07/2023
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   Comparison Between High Flow Nasal Cannula And Conventional Method Of Apnoeic Oxygenation In Patients Undergoing Rigid Bronchoscopy 
Scientific Title of Study   Efficacy Of High Flow Nasal Cannula Oxygenation Versus Apnoeic Oxygenation In Patients Undergoing Rigid Bronchoscopy - A Prospective Randomized Control Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manisha S 
Designation  Post Graduate Resident (MD Anaesthesiology) 
Affiliation  Baroda Medical College 
Address  Department of Anesthesiology Baroda Medical College Vadodara Gujarat

Vadodara
GUJARAT
390001
India 
Phone  9677061096  
Fax    
Email  sivashankaranmanisha@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Swati Bhatt 
Designation  Professor 
Affiliation  Baroda Medical College 
Address  Department of Anaesthesiology Baroda Medical College Vadodara Gujarat

Vadodara
GUJARAT
390001
India 
Phone  9879372038  
Fax    
Email  drswatibhatt2015@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Swati Bhatt  
Designation  Professor 
Affiliation  Baroda Medical College 
Address  Department of Anaesthesiology Baroda Medical College Vadodara Gujarat

Vadodara
GUJARAT
390001
India 
Phone  9879372038  
Fax    
Email  drswatibhatt2015@yahoo.com  
 
Source of Monetary or Material Support  
Baroda Medical College Vadodara Gujarat - 390001 
 
Primary Sponsor  
Name  Baroda Medical College 
Address  Baroda Medical College Vadodara Gujarat- 390001 
Type of Sponsor  Government medical college 
 
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 
Manisha S   Baroda Medical College   Ward No 19 Department of ENT Baroda Medical College Vadodara Gujarat-390001
Vadodara
GUJARAT 		 9677061096

sivashankaranmanisha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Human Research and Postgraduate Research Baroda Medical College and SSG Hospital Vadodara  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 method of apnoeic oxygenation - closed circuit   Apnoeic oxygenation will be provided by the conventional method of delivering oxygen via the ventilator circuit through the side port of the bronchoscope at flow rate of 6L/min from onset of apnea till end of procedure when rigid bronchoscopy is being performed as elective or emergency procedure usually lasting around 20 minutes 
Intervention  High Flow Nasal Cannula Apnoeic Oxygenation  Apnoeic oxygenation will be given using high flow nasal cannula at 30L/min FiO2 100 percent at 35 degree Celsius from onset of apnoea till end of procedure in patients undergoing rigid bronchoscopy in the department of ENT as an elective or emergency procedure usually lasting around 20 minutes  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients undergoing elective/emergency Rigid
Bronchoscopy

Age 18 - 60 years of either Gender

BMI <30 kg/m2

Patients conformed to ASA 2, 3 
 
ExclusionCriteria 
Details  Inability or refusal to follow the study protocol.
Patients with tracheostomy tube in situ, intubated
patients.
Patients with severe lung disease, hepatic and renal,
cardiac dysfunction.
Patients in hypotension and shock 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
incidence & the time to desaturate to less then 92 percent peripheral oxygen saturation for more than 10 seconds  incidence & the time to desaturate to less then 92 percent peripheral oxygen saturation for more than 10 seconds 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of hypercarbia post procedure by monitoring
EtCO2 levels

EtO2 levels post procedure

Number of interruptions during the procedure due to fall in
SpO2

Severe complications suchas SpO2 less than 80 percent, systolic blood
pressure less than 80 mmHg or vasopressor initiation 		 EtCO2 measured at 5 10 & 15 minutes post procedure

EtO2 measured immediately post procedure 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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 4 
Date of First Enrollment (India)   01/09/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
TITLE:
EFFICACY OF HIGH FLOW NASAL CANNULA OXYGENATION VERSUS APNOEIC OXYGENATION IN PATIENTS UNDERGOING RIGID BRONCHOSCOPY - A PROSPECTIVE RANDOMIZED CONTROL STUDY

AIMS & OBJECTIVES:
Our goal is to compare the efficacy of High Flow Nasal Cannula with other methods of apnoeic oxygenation in patients undergoing rigid bronchoscopy to provide a better mode of oxygenation and to prevent hypoxia and the adverse effects related to it.

Primary Objectives:
1. Incidence and the time to desaturate to an Spo2 <92% for more than 10 seconds

Secondary Objectives:
1. Incidence of hypercarbia post procedure by monitoring EtCO2 levels
2. EtO2 levels post procedure
3. Number of interruptions during the procedure due to fall in SpO2
4. Severe complications (SpO2< 80%, systolic blood pressure <80 mmHg or vasopressor initiation)
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MATERIALS AND METHODS: 
110 patients belonging to age group between 18-60 years of both genders who are scheduled to undergo elective or emergency rigid bronchoscopy are randomised into 2 groups

GROUP H
ï‚· In this group, patients will be given apnoeic oxygenation via High Flow Nasal Cannula with heated humidified oxygen at 37 degrees Celsius at an FiO2 of 100% at a flow rate of 30L/minute after the patient has been induced and bronchoscopy procedure has begun.
GROUP A
ï‚· In this group, patients will be given apnoeic oxygenation via the side port of bronchoscope with oxygen at an FiO2 of 100% at a flow rate of 6L/minute after the patient has been induced and bronchoscopy procedure has begun.

Patient will be premedicated before the procedure and baseline vital parameters such as blood pressure, pulse rate, peripheral oxygen saturation, EtCO2, EtO2 will be noted and both the groups will be preoxygenated using bag and mask with 100% oxygen at 10L/min for 3 minutes . Following the onset of apnoea after giving induction agents different methods of apnoeic oxygenation will be employed as mentioned above. The pulse rate , blood pressure and the peripheral oxygen saturation will be monitored throughout the procedure every minute and bag mask ventilation will be done if the SpO2 falls below 92%. once the procedure is over bag and mask ventilation is done until the patient regains spontaneous respiration and the EtCO2 and EtO2 immediately and 5, 10 mins post procedure will be noted . 


 
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