| CTRI Number |
CTRI/2025/09/094130 [Registered on: 02/09/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Which Works Better to Keep Oxygen Levels Safe in Obese Patients Before Surgery: Oxygen Tubes (HFNO) or Face Mask?
|
|
Scientific Title of Study
|
To compare the efficacy of HFNO with bag mask ventilation for preoxygenating the obese patients posted for surgeries under general anaesthesia using ORI – 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 |
Samarjit Dey |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Mangalagiri |
| Address |
1053,1st floor,Department of Anaesthesiology, IPD, AIIMS Mangalagiri
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
8014910806 |
| Fax |
|
| Email |
drsamarjit@aiimsmangalagiri.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Ananthakrishnan P M |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Mangalagiri |
| Address |
1st floor,Department of Anaesthesiology, IPD, AIIMS Mangalagiri
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
6282719364 |
| Fax |
|
| Email |
ananthakrishnan6472@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ananthakrishnan P M |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Mangalagiri |
| Address |
1st floor,Department of Anaesthesiology, IPD, AIIMS Mangalagiri
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
6282719364 |
| Fax |
|
| Email |
ananthakrishnan6472@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Mangalagiri, Andhra Pradesh,India
Pin 522503 |
|
|
Primary Sponsor
|
| Name |
AIIMS MANGALAGIRI |
| Address |
AIIMS Mangalagiri, Guntur, Andhra Pradesh, 522503 |
| 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 |
| Samarjit Dey |
All India Institute of Medical Sciences |
Department of Anaesthesiology, 1054
Guntur
ANDHRA PRADESH |
8014910806
drsamarjit@aiimsmangalagiri.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS MANGALAGIRI Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
(Group c)Conventional Group |
patients will be preoxygenated with 100% oxygen with bag and mask till the patient achieves an optimal ORI of 0.3 |
| Intervention |
(Group I) Interventional group |
patients will be preoxygenated with 100% oxygen High-Flow Nasal oxygen cannula till the patient achieves an optimal ORI of 0.3 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Obese patients posted for surgeries under general anaesthesia , BMI more than 30 kg per m² |
|
| ExclusionCriteria |
| Details |
History of respiratory failure or significant pulmonary disease , Severe cardiovascular comorbidities , Any pathology involving nasal passage (polyp, inferior turbinate hypertrophy etc.),Pregnant women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to achieve optimal ORI level of 0.3 |
0,30 sec ,60 sec,90 sec,120 sec , 180 sec |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comfort & tolerability during preoxygenation |
Post operatively 15 min after emergence from anesthesia |
| To monitor any adverse events or complications. |
Post-operatively 0,15 min after emergence from anesthesia |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
01/10/2025 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Endotracheal intubation necessitates an anaesthetic induction that leads to loss of consciousness and neuromuscular paralysis. This process can cause hypoventilation and apnea, increasing the risk of hypoxia, especially in challenging intubation scenarios. As a result, it is essential to perform careful preoxygenation when the patient is breathing spontaneously. This step is particularly vital for managing airway control in obese patients, who are more susceptible to hypoxia during anaesthesia induction. While traditional techniques like bag-mask ventilation (BMV) have been commonly used, newer approaches such as high-flow nasal oxygen (HFNO) are becoming more popular due to their advantages in enhancing oxygenation and reducing the likelihood of desaturation.
Obesity and Anaesthesia Challenges: Obesity significantly alters respiratory physiology, leading to decreased functional residual capacity, increased oxygen consumption and impaired airway mechanics. These factors increase the likelihood of perioperative complications, particularly during periods of apnoea that occur during intubation. Effective preoxygenation is essential to enhance the safety of anaesthesia induction in this population. Pulse oximeter provides no indication of downward trends in PaO2 until saturation begins to fall. The ORI is a novel pulse oximeter–based non dimensional index that ranges from 0 to 1 correlating PaO2 from 80 to 200 mmHg and is measured by optically detecting changes in SvO2 once SaO2 saturates to the maximum. Therefore during a crisis, having a reliable estimate of time remaining, before hypoxemia ensues, would help guide management. |