| CTRI Number |
CTRI/2022/09/045294 [Registered on: 07/09/2022] Trial Registered Prospectively |
| Last Modified On: |
17/04/2026 |
| 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
|
Comparing two methods of giving oxygen during anesthesia i.e. High Flow nasal Oxygen or routinely done bag-mask ventilation in patients with difficult mask ventilation. |
|
Scientific Title of Study
|
Comparison of high flow nasal oxygen vs conventional bag mask ventilation for preoxygenation and apnoeic oxygenation in adults with difficult mask ventilation under general anaesthesia: an open labelled randomised controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
BHARAT PALIWAL |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur,INDIA |
| Address |
Anaesthesiology and Critical Care Department, All India Institute of Medical Sciences Jodhpur, Basni, Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9588089378 |
| Fax |
|
| Email |
docbpali@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
BHARAT PALIWAL |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur,INDIA |
| Address |
Anaesthesiology and Critical Care Department, All India Institute of Medical Sciences Jodhpur, Basni, Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9588089378 |
| Fax |
|
| Email |
docbpali@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vanlaltlani Khawlhring |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur,INDIA |
| Address |
Anaesthesiology and Critical Care Department, All India Institute of Medical Sciences Jodhpur, Basni, Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8969975066 |
| Fax |
|
| Email |
ktlani14@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences Jodhpur |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Medical SciencesAIIMS Jodhpur |
| Address |
Marudhar Industrial Area, 2nd Phase, MIA 1st Phase, Basni, Basni, Jodhpur, Rajasthan 342005 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Bharat Paliwal |
All India Institute Of Medical Sciences(AIIMS) Jodhpur |
Department of Anaesthesiology & Critical Care
Basni Industrial Area Phase-2, Jodhpur-342005, Rajasthan.
Jodhpur
RAJASTHAN |
9588089378
docbpali@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS, Jodhpur |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bag mask ventilation |
Preoxygenation and apneic oxygenation will be done. In preoxygenation, bag mask group will receive preoxygenation with 100% oxygen
and flow at 10L/min for 3 minutes via mask connected to closed system anaesthesia
machine. At the end of preoxygenation, standard anaesthesia induction. Bag mask group will continue to receive 100% oxygen and flow at 10L/min with addition of positive pressure ventilation after induction. The study in this group ends after the reoxygenation time, defined as the time taken for SpO2 to return to 100% after mechanical ventilation, is noted. |
| Intervention |
High flow nasal oxygen |
Preoxygenation and apneic oxygenation with high flow nasal oxygen. HFNO group will receive 100% oxygen and flow 30L/min for 3 minutes
via high flow nasal canula.
At the end of preoxygenation, standard anaesthesia induction. HFNO group will continue receiving 100% oxygen at 60L/min till intubation is done. The HFNO will be discontinued after the reoxygenation time, defined as the time taken for SpO2 to return to 100% after mechanical ventilation, is noted. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. All ASA I &II aged 18-65 Years posted for general anaesthesia who are anticipated difficult airway comprising of the following
a) Patients with BMI >25
b) Absence of teeth
c) History of snoring
d) Bearded patient
e) Mallampati grade III and IV
f) Severely limited mandibular protrusion
g) Face and neck deformities due to prior surgery, prior trauma, congenital abnormalities
h) Previous and current cervical spine injuries
i) Patients with rheumatoid arthritis, scleroderma
j) Patients with oropharyngeal cancers
2. Consent for participation
|
|
| ExclusionCriteria |
| Details |
1. Pregnant females
2. Patients having cardiorespiratory pathologies
3. Patients who are planned for rapid sequence induction
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary objective is to assess the difference in partial pressure of oxygen, after 3 min of preoxygenation in patients preoxygenated with HFNO vs patients preoxygenated with bag mask ventilation |
The difference in partial pressure of oxygen will be noted by taking arterial blood sample after three minutes of pre oxygenation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Difference in partial pressure of oxygen. |
After intubation |
| 2. Difference in end tidal O2 |
After intubation |
| 3. Incidence of hypoxemic events(SpO2 92%) |
Number of Events until intubation |
| 4. Tolerability of high flow nasal canula by patients, i.e., if patients request to reduce flow or feeling of dryness, itching etc. |
Till induction |
| 5.Time taken to successful intubation |
After Intubation |
| 6. Any complications until following intubation like arrhythmias |
After intubation |
| 7. Reoxygenation time defined as the time taken for SpO2 to return to 100% after mechanical ventilation. |
After initiation of Mechanical ventilation |
|
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Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/09/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="1"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
When anaesthesia is induced, hypoxemia can quickly develop as a result of hypoventilation or apnoea in combination with decreased FRC. Preoxygenation is the process of replacing nitrogen in the lungs with oxygen which will provide an increase in time before hemoglobin desaturation occurs. Preoxygenation is conventionally performed by 3 min of tidal volume breathing of 100% oxygen via bag-mask attached to an anaesthesia machine or a Mapleson circuit. The flow rate of oxygen is kept high enough to prevent rebreathing (10-12L/min). To ensure adequate preoxygenation, no leaks around the mask must be present. After preoxgenation an induction agent, and subsequently a muscle relaxant is administered. During the apnoea period after induction and muscle relaxant administration, the oxygenation is maintained using the continued bag and mask ventilation. Safe apnoea time is typically defined as the time from spontaneous cessation of breathing until the peripheral arterial oxygen concentration (SpO2) falls below 90%. With maximal preoxygenation, the time to oxyhaemoglobin desaturation below 90% can be up to 8 minutes in adults with normal airway and around 3 minutes or less in children and obese adult patients. Preoxygenation, apnoeic oxygenation by bag-mask ventilation, and consequently intubation without the unwanted event of hypoxemia in adults with difficult bag-mask ventilation can be a challenging task for an anaesthesiologist. Hence, it is the need of the hour to come up with an alternative technique of oxygenation in such subset of patients. Recent studies have provided evidence of using the High Flow Nasal Oxygen to prolong apnoea time and tool to achieve preoxygenation effectively. High flow nasal oxygen (HFNO) via high flow nasal canula (HFNC) can deliver oxygen at flow rate up to 60L/min with more predictable FIO2 than with other devices and may generate PEEP and increase end-expiratory lung volume (EELV) Hence this study is conducted to compare High Flow Nasal Oxygen vs conventional bag-mask ventilation for preoxygenation and apnoeic oxygenation in adults with difficult bag-mask ventilation under general anaesthesia. No study has been conducted till now on the adult patient population with difficult bag mask ventilation. We hypothesize that high flow nasal oxygenation is as effective as the conventional bag-mask ventilation in delivering adequate preoxygenation and apnoeic oxygenation in adults with difficult bag-mask ventilation under general anaesthesia |