| 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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- 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
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [nitabhartimgims@rediffmail.com].
- 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.
- 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. |