| CTRI Number |
CTRI/2024/05/067510 [Registered on: 16/05/2024] Trial Registered Prospectively |
| Last Modified On: |
09/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the effect of two different flow rates of high flow nasal cannula on increasing the oxygen content of blood during the start of general anaesthesia. |
|
Scientific Title of Study
|
Comparison of apnoeic oxygenation efficiency using high flow nasal cannula at two different flow rates in patients posted for surgery under general anaesthesia |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nitya Nyalakonda |
| Designation |
Post graduate student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anaesthesiology, Maulana Azad Medical College
New Delhi
DELHI
110002
India |
| Phone |
9021643760 |
| Fax |
|
| Email |
nitya.nyalakonda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Mona Arya |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anaesthesiology, Maulana Azad Medical College
New Delhi
DELHI
110002
India |
| Phone |
9021643760 |
| Fax |
|
| Email |
monaarya@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nitya Nyalakonda |
| Designation |
Post graduate student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anaesthesiology, Maulana Azad Medical College
New Delhi
DELHI
110002
India |
| Phone |
9021643760 |
| Fax |
|
| Email |
nitya.nyalakonda@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and associated Lok Nayak Hospital, Bahadur Shah Zafar Marg, New Delhi- 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi- 110002 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Nitya Nyalakonda |
Maulana Azad Medical College |
Dept. of Anaesthesiology,
Maulana Azad Medical College/
New Delhi- 110002.
New Delhi
DELHI |
9021643760
nitya.nyalakonda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College and Associated Hospitals |
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 |
HFNC flow of 40L/min for 3 minutes during apnoeic oxygenation. |
During induction of general anaesthesia, preoxygenation will be done at 40 L/min flow rate using High Flow Nasal Cannula for 3 minutes followed by apnoeic oxygenation at 40 L/min for 3 minutes. We will be measuring PaO2 after 3 mins of apnoeic oxygenation by ABG. |
| Intervention |
HFNC flow of 60L/min for 3 minutes during apnoeic oxygenation. |
During induction of general anaesthesia, preoxygenation will be done at 40 L/min flow rate using High Flow Nasal Cannula for 3 minutes followed by apnoeic oxygenation at 60 L/min for 3 minutes. We will be measuring PaO2 after 3 mins of apnoeic oxygenation by ABG. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status I and II |
|
| ExclusionCriteria |
| Details |
Any known contraindication to HFNC: bleeding in nose or oropharynx, pre-existing nasal obstruction, greater than 50 percent of nares occluded by nasal prongs.
Patients on oxygen therapy.
Any underlying chronic or restrictive lung disease (kyphoscoliosis, burn contractures).
Previous lung surgery.
BMI greater than 35 kg per meter square.
Planned for awake intubation or a difficult airway.
Any contra-indication to continuous positive airway pressure (CPAP) treatment.
Pregnant patients, autonomic neuropathy, history of gastro-esophageal reflux disease(GERD). |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PaO2 in both the groups. |
At the end of 3 minutes of apnoeic oxygenation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean difference in PaO2 and PaCO2 levels in both groups (baseline, after 3 minutes of pre-oxygenation, after 3 minutes of apnoeic oxygenation) .
End tidal oxygen (FETO2) and End tidal carbon dioxide (ETCO2) after securing a definitive airway and after 3 minutes.
Percentage of population with hypoxemia (SpO2 less than 92%).
Patient comfort during pre-oxygenation immediately before induction on a 5 point Likert scale. |
Baseline, after 3 minutes of pre-oxygenation, after 3 minutes of apnoeic oxygenation, after securing a definitive airway and after 3 minutes of securing a definitive airway. |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/05/2024 |
| 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)
|
Open to Recruitment |
| 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
|
This study is a prospective, randomized, comparative, single centre study comparing the efficiency of apnoeic
oxygenation using high flow nasal cannula at 40 L/min and 60L/min in adult patients posted for surgery under general anaesthesia. A total of 56 patients will be recruited with 28 patients in each group. We
hypothesized that HFNC flow of 40 L/min during apnoea period should provide
similar oxygenation as that obtained by HFNC flow of 60 L/min. In both groups, pre-oxygenation will be done using high flow nasal cannula at 40 L/min for 3 minutes. After induction, the flow rate will be kept at 40 L/min in group F and increased to 60 L/min in group S for 3 minutes after which a definitive airway will be secured. The primary outcome will be partial pressure of arterial oxygen (PaO2) at the end of 3 minutes of apnoeic oxygenation in both groups. The secondary outcomes will be mean difference in PaO2 and
PaCO2 levels in both groups (baseline, after 3 minutes of pre-oxygenation,
after 3 minutes of apnoeic oxygenation, End-tidal oxygen (FETO2) and
End-tidal carbon dioxide (ETCO2) after securing a definitive airway and after 3
minutes, percentage of population with
hypoxemia (SpO2 < 92%), patient comfort during
pre-oxygenation immediately before induction on a 5 point Likert scale.
|