| CTRI Number |
CTRI/2025/02/080825 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
02/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing Three Methods of Providing Oxygen to Patients Under Anaesthesia When They Cannot Breathe on Their Own |
|
Scientific Title of Study
|
To compare the efficacy of apnoeic oxygenation by nasopharyngeal airway vs nasal cannula vs THRIVE during airway management under general anaesthesia :A Prospective Randomised 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 |
Shrutijharna Das |
| Designation |
Junior Resident |
| Affiliation |
AIIMS NEW DELHI |
| Address |
Department of Anaesthesiology, Pain Medicine & Critical Care. Room No-5011, 5th floor. Teaching Block, AIIMS. Ansari Nagar, New Delhi-110029.
New Delhi
DELHI
110049
India |
| Phone |
|
| Fax |
|
| Email |
shrujharna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Devalina Goswami |
| Designation |
Professor |
| Affiliation |
AIIMS NEW DELHI |
| Address |
Department of Anaesthesiology, Pain Medicine & Critical Care. Room No-5011, 5th floor. Teaching Block, AIIMS. Ansari Nagar, New Delhi-110029.
New Delhi
DELHI
110049
India |
| Phone |
|
| Fax |
|
| Email |
dr.devalina@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shrutijharna Das |
| Designation |
Junior Resident |
| Affiliation |
AIIMS NEW DELHI |
| Address |
Department of Anaesthesiology, Pain Medicine & Critical Care. Room No-5011, 5th floor. Teaching Block, AIIMS. Ansari Nagar, New Delhi-110029.
DELHI
110049
India |
| Phone |
|
| Fax |
|
| Email |
shrujharna@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi, India Pincode - 110029 |
|
|
Primary Sponsor
|
| Name |
Shrutijharna Das |
| Address |
Hostel-19, AIIMS campus-1, Gautam Nagar, New Delhi 110049 India |
| Type of Sponsor |
Other [Self] |
|
|
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 Shrutijharna Das |
All India Institute of Medical Sciences |
Department of Anaesthesiology, Pain Medicine and Critical Care. Room No 5011, 5th floor. Teaching Block, AIIMS. Ansari Nagar, New Delhi 110029
New Delhi
DELHI |
8250529474
shrujharna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of ethics committee for post graduate research AIIMS |
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 |
Nasopharyngeal airway, nasal cannula , THRIVE |
1. Nasopharyngeal airway : A device inserted into the nasal passage to maintain airflow and deliver oxygen.
2. Nasal cannula : A thin tube placed in the nostrils to provide continuous oxygen.
3. THRIVE (Transnasal Humidified Rapid-Insufflation Ventilatory Exchange) : A method using humidified, high-flow oxygen through nasal cannula to maintain oxygenation |
| Comparator Agent |
Nasopharyngeal airway, Nasal cannula, THRIVE |
Comparison of the above three oxygen delivery methods focusing on maintaining adequate oxygen saturation during apnoeic oxygenation in patients under anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA PS I and II
2. Patients with normal cardiorespiratory function
3. Patients with thyromental distance more than 6cm
4. Patients with MMPG I,II and mouth opening more than 2.5cm
5. Patients with normal mask ventilation |
|
| ExclusionCriteria |
| Details |
Patients with
1. Anatomical abnormalities or a surgical history of the face, nose or upper airway
2. Nasal obstruction or difficult airway
3. Elevated intracranial pressure
4. Uncontrolled hypertension
5. BMI more than 30kg per m2
6. Refusal of consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of apnoeic oxygenation by nasopharyngeal airway vs nasal cannula vs THRIVE in prolonging the duration of apnoea |
8 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To assess arterial oxygen partial pressures, arterial carbon dioxide partial pressure after the induction of anaesthesia and at the end of 8 minutes or when SpO2 drops to 95% whichever occurs earlier 2. To assess SBP, DBP, MAP and HR every 30 seconds |
2 years |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Title of the study: To compare the efficacy of apnoeic oxygenation by nasopharyngeal airway vs nasal cannula vs THRIVE during airway management under general anaesthesia : A Prospective Randomised Controlled Trial Primary Objective: To compare the efficacy of apnoeic oxygenation by nasopharyngeal airway vs nasal cannula vs THRIVE in prolonging the duration of apnoea up to a period of 8 minutes or till oxygen saturation (SpO2) is < 95% whichever is earlier Secondary objective: 1. To assess the PaO2, PaCO2 after the induction of anesthesia and at the end of 8 minutes or when oxygen saturation falls to 95% whichever occurs earlier. 2. To assess SBP, DBP, MAP, HR every 30 seconds for 8 minutes or till SpO2 falls to 95% Sample Size: Total 120 patients with 40 patients in each group Randomisation: The patients will be randomised into three groups. Randomization will be done by using Sequentially Numbered Opaque Sealed Envelope technique concealig the randomization group as determined by a computer generated random numbers table. Methodology: All selected patients will undergo a routine pre anesthetic check up a day prior to surgery. Standard fasting guidelines (WHO) will be followed by all patients. In the operating room, standard monitoring will be done as per ASA recommendation. Patients will be placed in a supine position with their heads elevated approximately 15 degrees. Preoxygenation will be done with 100% oxygen for 3 minutes. General anesthesia will be administered to the patient as per the standard protocol of the institute. Once induced, according to the randomization and group assigned to the patient, the anesthetist will place a nasopharyngeal airway or nasal cannula or THRIVE on the patient. Group P: will receive !00% oxygen @5L/min via nasopharyngeal airway Group C : will receive 100% oxygen@5L/min via nasal cannula Group H: will receive 100% oxygen @70L/min via THRIVE SpO2 will be closely monitored. Timing will be terminated when the safe apnoea time of 8 minutes or if the SpO2 drops tp 95% at any time before 8 minutes. Arterial blood gas analysis will be done at two separate times 1. After the induction of anesthesia 2. at the end of 8 minutes or when SpO2 drops to 95% whichever occurs earlier. Maintenance and reversal of anesthesia will be as per standard protocol Outcome parameters: 1. safe apnoea duration 2. Number of patients whose SpO2 dropped to or below 95% 3. PaO2 and PaCO2 immediately after induction of anesthesia and at the end of 8 minutes 4. SBP, DBP, MAP and HR every 30 seconds for 8 minutes
|