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CTRI Number  CTRI/2023/10/058602 [Registered on: 12/10/2023] Trial Registered Prospectively
Last Modified On: 30/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   study to compare high flow & low flow oxygen to assess oxygen fall while putting tube in trachea using a scope. 
Scientific Title of Study   Clinical comparison of high flow nasal oxygen Vs low flow nasal co-oxygenation for reducing hypoxic events in patients undergoing fibreoptic bronchoscope guided orotracheal intubations:A randomised control 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  Nita Bharti 
Designation  Junior resident 
Affiliation  All India Institute of Medical Science,Patna 
Address  room 501, b5a, IPD Building, Department of Anaesthesiology All India Institute Of Medical Sciences, Phulwarisharif, Patna, Bihar.
room 301, hostel 11, AIIMS Patna, Phulwarisharif, Patna Bihar. 801507
Patna
BIHAR
801507
India 
Phone  7669019935  
Fax    
Email  nitabhartimgims@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Umesh Kumar Bhadani 
Designation  Professor & Head of department 
Affiliation  All India Institute of Medical Science,Patna 
Address  room 501, b5a, IPD Building, Department of Anaesthesiology All India Institute of Medical Science,Patna Phulwarisharif,Patna
Department of Anaesthesiology All India Institute of Medical Science,Patna Phulwarisharif,Patna, 801507
Patna
BIHAR
801507
India 
Phone  8969169123  
Fax    
Email  umeshbhadani@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Umesh Kumar Bhadani 
Designation  Professor & Head of department 
Affiliation  All India Institute of Medical Science,Patna 
Address  Room 501, b5a, IPD Building, Department of Anaesthesiology All India Institute of Medical Science,Patna Phulwarisharif,Patna
Department of Anaesthesiology All India Institute of Medical Science,Patna Phulwarisharif,Patna. 801507
Patna
BIHAR
801507
India 
Phone  8969169123  
Fax    
Email  umeshbhadani@gmail.com  
 
Source of Monetary or Material Support  
All India Institute Of Medical Sciences,Patna 
 
Primary Sponsor  
Name  All India Institute Of Medical Science,Patna 
Address  Department of Anaesthesiology All India Institute Of Medical Science,Patna Phulwarisharif Patna,Bihar 
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 Umesh Kumar Bhadani  All India Institute of Medical Sciences  5th floor Operation theatre, IPD building,AIIMS Patna, NH98, Phulwarisharif, Patna 801507
Patna
BIHAR 
8969169123

umeshbhadani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS PATNA  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 
Intervention  High flow nasal oxygen at 60 litre per minute and FiO2 1 will be started about 10 minutes before intubation attempts and then continued throughout the attempts at intubation.   High flow nasal oxygen at 60 litre per minute and FiO2 1 will be started about 10 minutes before intubation attempts are initiated and then the same flows will be continued throughout the process of intubation till confirmation of intubation.  
Comparator Agent  Low flow oxygenation by nasal prong at rate of 6 litre per minute.  After 7 mins of start of drug infusions, pre oxygenation by face mask will be done using the tidal volume technique via a Magill’s circuit to ensure an ETO2 93%. Injection propofol will then be given for sedation and a low flow oxygen supplementation using 6 litres per minute of oxygen by nasal prong will be continued.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All patients posted for elective surgery and needing oral fibreoptic bronchoscope guided intubation.  
 
ExclusionCriteria 
Details  1. Conditions precluding use of high flow nasal oxygen eg recent epistaxis, perforated nasal septum.
2. Patients in whom awake fibrescope guided intubation is indicated.
3. Mouth opening < 3 cm.
4. Pregnant women
5. Patients with history of trauma.
6 when patients baseline saturation is <95%.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To estimate the percentage of patients in whom there is a fall of saturation (SPO2) more than 10 % from base line, during fibre optic bronchoscope guided orotracheal intubation.  10 minutes  
 
Secondary Outcome  
Outcome  TimePoints 
Lowest SpO2 during fibreoptic bronchoscope guided orotracheal intubation.
 
10 min 
PaCO2 & PaO2 at the confirmation of intubation.  10 min 
PaO2 level at the start of fibreoptic bronchoscope guided orotracheal intubation.
 
5 minutes 
No. of hypoxemic events ( fall of SpO2 10 % from baseline ) during fiberoptic bronchoscope guided orotracheal intubation.  10 minutes 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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)   12/10/2023 
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 Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [nitabhartimgims@rediffmail.com].

  6. For how long will this data be available start date provided 01-07-2023 and end date provided 10-02-2029?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

A fibreoptic bronchoscope is used for both diagnostic and therapeutic purposes. In anesthesia, it is used to aid intubation especially during anticipated difficult airway situations. Hypoxemia during the process of fibreoptic bronchoscopic intubation is common. This can induce anxiety and hinder the performance of the procedure which in a difficult airway situation can be very cumbersome. Transient apnoea during fibreoptic bronchoscopy either produced due to the drugs or as a reflex due to irritation of the airway can also complicate the situation.

There are different ways of oxygen supplementation.  Traditionally this supplementation is by means of low-flow oxygen nasal cannula (LFNC) which can effectively provide only up to 4 to 6 liters per minute of supplemental oxygen. Often these flows are not enough and in more than 45% of patients desaturation has been noted. High flow nasal oxygenation is new system which is capable of delivering up to 100% humidified and heated oxygen at flow rates of upto 60 liters per minute, and a humidifier that saturates the gas mixture to a temperature of 31 to 37 C. A high-flow nasal cannula accomplishes a reduction of nasopharyngeal airway resistance, leading to improved ventilation and oxygenation through the application of a positive pressure environment. Hypoxemic events are reduced by other different proposed mechanisms (washout of dead space, intrinsic PEEP etc) which low flows can not do.

This prospective randomised study tries to assess whether high flow nasal oxygen reduce episodes of desaturation during fibrescope guided intubations when compared with standard low flow (6L/min) co-oxygenation in adult patients. It will also compare the lowest oxygen saturations  reached during intubation and the arterial partial pressures of oxygen and carbon dioxide at the confirmation of intubation. The total number of episodes of hypoxemic events (fall of SpO2 >10% from baseline) would also be noted and compared.

 

 
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