| CTRI Number |
CTRI/2024/12/077664 [Registered on: 04/12/2024] Trial Registered Prospectively |
| Last Modified On: |
01/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
PranNiti Oxygen Device Versus Regular Oxygen therapy in patients with low oxygen after surgery |
|
Scientific Title of Study
|
A Comparative Study of PranNiti and Standard Oxygen Therapy in Post- Extubation Patients with Type I Respiratory Failure |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashish Singh Aditya |
| Designation |
Assistant Professor |
| Affiliation |
Post Graduate Institute of Medical Education & Research (PGIMER) |
| Address |
Department of Anaesthesia, Level 4, Nehru Hospital, PGIMER, Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09914406496 |
| Fax |
|
| Email |
ashish09399@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashish Singh Aditya |
| Designation |
Assistant Professor |
| Affiliation |
Post Graduate Institute of Medical Education & Research (PGIMER) |
| Address |
Department of Anaesthesia, Level 4, Nehru Hospital, PGIMER, Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09914406496 |
| Fax |
|
| Email |
ashish09399@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashish Singh Aditya |
| Designation |
Assistant Professor |
| Affiliation |
Post Graduate Institute of Medical Education & Research (PGIMER) |
| Address |
Department of Anaesthesia, Level 4, Nehru Hospital, PGIMER, Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09914406496 |
| Fax |
|
| Email |
ashish09399@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post graduate institute of medical education and research (PGIMER) Sector 12 Chandigarh 160012 INDIA |
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
Department of Anaesthesia and Intensive Care, Nehru Hospital, PGIMER, Sector-12 Chandigarh |
| 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 |
| Dr Ashish Singh Aditya |
Nehru Hospital |
Post Anaesthesia Care Unit (PACU), 4th Floor, Department of Anaesthesia, Nehru hospital, PGIMER, sector 12
Chandigarh
CHANDIGARH |
9914406496
ashish09399@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER Instituional Ethics Committee |
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 |
PranNiti Oxygen device |
Oxygen will be administered to the participants using PranNiti Oxygen device with input oxygen flows of 4 liter per minute.
Any escalation of Oxygen flows will be recorded |
| Comparator Agent |
Standard oxygen therapy-Nasal prongs |
oxygen will be administered to the participants using nasal prongs with oxygen flows of 4 liter per minute.
Any escalation of Oxygen flows will be recorded |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Type 1 respiratory failure
Spo2 less than 96
respiratory rate less than 30 |
|
| ExclusionCriteria |
| Details |
Patients with baseline spo2 greater than 96
Parturient refusal to consent
Severe Respiratory failure with Spo2 less than 85 RR more than30
Clinically significant respiratory distress, for example retractions, grunting, cyanosis, possible Co2 narcosis.
severe comorbidities like severe heart failure, pregnancy, etc.
nasal injury, emphysematous bullae, severe valvular heart disease, cyanotic heart disease and nasal surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Absolute changes in arterial partial pressure of oxygen (PaO2) |
30 minutes after initiation of oxygen therapy. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
SpO2
Cerebral and somatic oxygenation
PaCO2 (arterial partial pressure of carbon dioxide)
Respiratory Rate
O2 flow and total O2 utilization
Episodes of disconnection |
every 5 minute till 30 minutes after initiation of oxygen therapy. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "108"
Final Enrollment numbers achieved (India)="108" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
16/12/2024 |
| Date of Study Completion (India) |
03/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
Currently available oxygen delivery devices have many shortcomings, factors such as mouth breathing or improper fit can result in inconsistent oxygen delivery, compromising therapy effectiveness. Also, ill-fitting of face masks and nasal cannula can leads to leakage of high concentrations of oxygen in the environment resulting in wastage of an important resource , environmental pollution, with associated increased risk of causing fire hazards. Subjective errors of not setting the flows while the equipment is in place whereas other situations of not proper placing of the equipment while the flows are on, not full filling the purpose. There is no inbuilt safety mechanism for detecting apnea and thus supply of oxygen continues even if the patient is not breathing. High flows rates are required to produce high fiO2 resulting in dryness of nose and oral cavity leading to patient discomfort. Addressing these concerns, an innovative and patented oxygen delivery device called PranNiti, is a great O2 conserving tool. The device is registered under FDA (Food and Drug Administration, Pune, Maharashtra division) with License no. MFG/MD/2023/001075. This is noninvasive oxygen supplementing device with required patient safety features. On initial trials it was proven to be able to give oxygen savings up to 70 % achieving better SPO2. Hence, the present study will be carried out in the post extubation patients with type 1 respiratory failure comparing the efficacy of the standard oxygen delivery device-Venturi mask with PranNiti. This study aims to provide evidence-based recommendations for optimizing oxygen therapy in post-extubation patients with type 1 respiratory failure. By comparing standard oxygen delivery devices with a newly developed device, this research has the potential to improve patient outcomes, enhance healthcare resource utilization, and guide clinical practice. |