| CTRI Number |
CTRI/2023/07/055747 [Registered on: 27/07/2023] Trial Registered Prospectively |
| Last Modified On: |
24/07/2023 |
| 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 three methods of giving oxygen before anaesthesia
using simple face mask and high flow nasal oxygen device in lying down versus head up position in patients undergoing abdominal surgeries |
|
Scientific Title of Study
|
Efficacy of head up position versus supine position with high flow nasal oxygenation compared with conventional preoxygenation in patients undergoing exploratory laparotomy: A randomised controlled study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ruchi Kapoor |
| Designation |
Professor |
| Affiliation |
UCMS and GTB Hospital |
| Address |
Room No 731A 7th floor OT Block, Department of anaesthesiology, UCMS and GTB Hospital, North east Delhi
North East
DELHI
110095
India |
| Phone |
9560678023 |
| Fax |
|
| Email |
rudoc@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ruchi Kapoor |
| Designation |
Professor |
| Affiliation |
UCMS and GTB Hospital |
| Address |
Room No 731A 7th floor OT Block, Department of anaesthesiology, UCMS and GTB Hospital, North east Delhi
North East
DELHI
110095
India |
| Phone |
9560678023 |
| Fax |
|
| Email |
rudoc@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyatosh |
| Designation |
Post Graduate Resident |
| Affiliation |
UCMS and GTB Hospital |
| Address |
ICU 2nd floor Dept of Anaesthesiology UCMS and GTB Hospital
North East
DELHI
110053
India |
| Phone |
9650081040 |
| Fax |
|
| Email |
priyatoshucms@gmail.com |
|
|
Source of Monetary or Material Support
|
| University College of Medical Sciences and Guru Teg Bahadur Hospital, Dilshad Garden , New Delhi- 110095 |
|
|
Primary Sponsor
|
| Name |
UCMS and GTB Hospital |
| Address |
Dept of Anaesthesiology, GTB Hospital, Dilshad Garden, New Delhi-110095 |
| 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 |
| Dr Ruchi Kapoor |
University college of medical sciences and GTB hospital |
Room No 731A 7th floor OT Block, Department of anaesthesiology, UCMS and GTB Hospital, North east Delhi
North East
DELHI |
9560678023
rudoc@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K659||Peritonitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HFNO |
In each patient , an arterial line will be secured after performing the modified allens test . A baseline ABG sample will be taken before the start of anaesthesia . Each patient will be preoxygenated for 5minutes using HFNO device with mouth closed for better efficacy of HFNO device .Another ABG sample be taken after 5 minutes of preoxygenation . Patients will be induced using Rapid sequence induction(RSI) followed by intubation while keeping the HFNO device in nostrils . After 1 minute of intubation another ABG sample will be taken and HFNO device will be removed . Patients will be monitored hemodynamically for the entire duration.
|
| Intervention |
HFNO HU |
In each patient , an arterial line will be secured after performing the modified allens test . A baseline ABG sample will be taken before the start of anaesthesia . Each patient will be given a 25 degrees head tilt using a manual inclinometer and will be preoxygenated for 5minutes using HFNO device with mouth closed for better efficacy of HFNO device .Another ABG sample be taken after 5 minutes of preoxygenation . Patients will be induced using Rapid sequence induction(RSI) followed by intubation while keeping the HFNO device in nostrils . After 1 minute of intubation another ABG sample will be taken and HFNO device will be removed . Patients will be monitored hemodynamically for the entire duration. |
| Comparator Agent |
SMO |
In each patient , an arterial line will be secured after performing the modified allens test . A baseline ABG sample will be taken before the start of anaesthesia . Each patient will be preoxygenated for 5minutes using standard anatomical face mask .Another ABG sample be taken after 5 minutes of preoxygenation . Patients will be induced using Rapid sequence induction(RSI) followed by intubation After 1 minute of intubation another ABG sample will be taken . Patients will be monitored hemodynamically for the entire duration. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with peritonitis undergoing Exploratory Laparotomy.
Patients ≥18 years of age.
Patients who have given consent.
|
|
| ExclusionCriteria |
| Details |
Pregnant women.
Hemodynamically unstable patients.
Patient in need of non-invasive ventilation.
Unconscious patients.
Patients requiring emergency intubation.
Psychiatric Patients.
Patient with severe cardiovascular disease.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the change in PaO2 after 5 mins of preoxygenation with HFNO with 25 degrees head up position versus HFNO in supine AND conventional preoxygenation using face mask. |
To compare the change in PaO2 after 5 mins of preoxygenation with HFNO with 25 degrees head up position versus HFNO in supine AND conventional preoxygenation using face mask. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare between the three groups:
1.Saturation of oxygen (SpO2) after preoxygenation.
2.SpO2 after 1 minute of intubation.
3.Lowest Spo2 from the start of preoxygenation to after 1 minute of intubation.
4.Incidence of desaturation (SpO2 93%) from the end of preoxygenation to intubation.
5.PaO2 after1 min of intubation.
6.PaCO2 after 1 min of intubation.
7.Tolerance of the patient for the device.
8.Anesthesiologist’s satisfaction using 5point Likert scale.
9.Duration of laryngoscopy in the three groups.
10.Duration of Intubation in all the groups.
11.Hemodynamic parameters after preoxygenation.
12.Hemodynamic parameters post-intubation.
|
1.After 5 minutes of preoxygenation
2.After 1 minute of intubation
3.Start of preoxygenation to after 1 minute of intubation
4.End of 5 minutes of preoxygenation to intubation
5.Till extubation |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
10/08/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
A total of 45 patients will be randomized and allocated into the following three groups: Ø Group SMO [Standard Mask Oxygenation] (n=15): Patient to be preoxygenated via an anatomical face mask at10L/min. Ø Group HFNO [High Flow Nasal Oxygen] (n=15): Patient to be preoxygenated via High Flow Nasal Oxygen at 50L/min with mouth closed with a FiO2 of 1(100%). Ø Group HFNO HU [High Flow Nasal Oxygen Head Up] (n=15): Patient to be preoxygenated at 25degree head up via high flow nasal oxygen at 50 L/min with mouth closed with a Fio2 of 1(100%) All patients will be distributed randomly into the above three groups and written informed consent will be taken from them. Arterial blood gas analysis (ABGA) will be done before the start of preoxygenation. This ABGA will be taken as standard and reference. Patients from each group will be preoxygenated with SMO, HFNO in supine position and HFNO with 25degree head up position for 5 minutes and ABGA will be performed 5 minutes after preoxygenation. Patients in the HFNO group and HFNO HU group will be asked to keep their mouths closed to ensure better efficacy of the HFNO. After preoxygenation, rapid sequence induction (RSI) will ensue and endotracheal intubation will be performed while keeping the HFNO canula in nostrils during intubation in the HFNO AND HFNO HU group. Another ABGA will be done 1 minute after intubation. The patient’s hemodynamics will be monitored for the entire duration of surgery and standard general anaesthesia protocol will be followed. Preoxygenation in 25degrees head position has been shown to improve oxygenation than standard preoxygenation; HFNO offers an effective alternative to standard preoxygenation. However, on an extensive search of literature we did not find any study where the effect of head up position using HFNO has been studied for exploratory laparotomy patients. Therefore, this study is designed to compare the efficacy of head up position using HFNO vs supine position as a preoxygenation technique when compared to standard face mask oxygenation by assessment of the arterial partial pressure (PaO2) at defined set time points following the preoxygenation in patients of exploratory laparotomy.The primary objective of this study is to compare the change in PaO2 after 5 mins of preoxygenation with HFNO with 25 degrees head up position versus HFNO in supine and conventional preoxygenation using a face mask. |