| CTRI Number |
CTRI/2019/05/019050 [Registered on: 10/05/2019] Trial Registered Prospectively |
| Last Modified On: |
10/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Early use of Non Invasive Ventilation by tight fitting facemask verus conventional ventilation with tube in respiratory distress in acute pancreatitis |
|
Scientific Title of Study
|
Early use of Non Invasive Positive Pressure Ventilation in Acute Hypoxemic Respiratory Failure in Acute Pancreatitis: A Randomised Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anshuman Elhence |
| Designation |
Senior resident, Gastroenterology |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Gastroenterology, All India Institute of Gastroenterology, New Delhi
New Delhi
DELHI
110023
India |
| Phone |
8587935706 |
| Fax |
|
| Email |
anshu27790@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Pramod Garg |
| Designation |
Professor, Gastroenterology |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Gastroenterology, All India Institute of Gastroenterology, New Delhi
New Delhi
DELHI
110023
India |
| Phone |
9810038116 |
| Fax |
|
| Email |
pgarg10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Pramod Garg |
| Designation |
Professor, Gastroenterology |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Gastroenterology, All India Institute of Gastroenterology, New Delhi
DELHI
110023
India |
| Phone |
9810038116 |
| Fax |
|
| Email |
pgarg10@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi |
| 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 |
| Anshuman Elhence |
All India Institute of Medical Sciences, New Delhi |
AB-2 ICU and ward ,2nd floor ,Department of Gastroenterology,
All India Institute of Medical Sciences, New Delhi
New Delhi
DELHI |
8587935706
anshu27790@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee for Postgraduates, AIIMS, New Delhi |
Approved |
| Institutional Ethics committee for post graduates, AIIMS,New Delhi |
Not Applicable |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K859||Acute pancreatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional oxygen therapy |
Participants randomised to control group will receive standard O2 therapy by venturi mask with a flow rate and FiO2 titrated to keep the SpO2 greater than 90 |
| Intervention |
Non Invasive Ventilation |
Participants randomised to intervention group will receive NIV via appropriate size face mask or helmet as preferred by the patient in bilevel positive airway pressure (BiPAP) mode. The starting inspiratory positive airway pressure will be 8 cm H2O which will be titrated by 2cm H2O to achieve a tidal volume of 6mL/kg or as tolerable. The expiratory positive airway pressure( EPAP) or peak end expiratory pressure(PEEP) will be kept at 4 cm H2O initially and titrated by 2cm H2O as tolerable. FiO2 will be titrated to keep SpO2 more than 90 percent
Disconnecting NIV will be allowed for oral toileting, meals and communication
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Acute pancreatitis as defined by revised Atlanta classification.1
2. Hospitalisation within 14 days of date of onset of pain.
3. Grade II/III respiratory failure as defined by modified Marshall’s criteria.
|
|
| ExclusionCriteria |
| Details |
1. Age < 18 years or > 70 years
2. Pregnancy
3. Failure to give consent
4. Undrained large pleural effusion
5. Previous mechanical ventilation in last 7 days
6. Contraindications to NIV use:
a. Glasgow coma scale <13/15.
b. Airway/facial injury.
c. Hypotension requiring inotropes.
d. Intractable vomiting.
e. Active gastrointestinal bleeding.
f. Untreated paralytic ileus.
g. Untreated pneumothorax.
h. Acute myocardial infarction/arythmmia/congestive heart failure.
7. Underlying chronic obstructive airway disease(COPD).
8. Renal failure requiring dialysis.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Need for invasive mechanical ventilation
2. Hospital acquired pneumonia |
within 30 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. mortality within 30 days
2. Duration of ICU stay
3. Duration of hospital stay
4. Incidence, severity and impact on outcome of acute respiratory failure in patients with acute pancreatitis |
within 30 days |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
Final Enrollment numbers achieved (Total)= "61"
Final Enrollment numbers achieved (India)="61" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/05/2019 |
| Date of Study Completion (India) |
01/09/2022 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The role of non invasive ventilation(NIV) in acute hypoxemic respiratory failure remains unclear. This trial’s objectives are: 1. to compare early NIV with conventional oxygen therapy for grade II/III acute hypoxemic respiratory failure in patients with acute pancreatitis in terms of need for invasive ventilation. 2. To study the frequency, causes amd imapct of respiartory failure on outcome in patients with acute pancreatitis.
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