| CTRI Number |
CTRI/2020/03/024398 [Registered on: 31/03/2020] Trial Registered Prospectively |
| Last Modified On: |
19/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Longitudinal study |
| Study Design |
Other |
|
Public Title of Study
|
Detection of Gastric distension with use of an oxygen delivery device in patients of respiratory diseases |
|
Scientific Title of Study
|
Gastric Insufflation
with High Flow Nasal Oxygen
in patients of Obstructive Airway Diseases:
an Observational Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pradeep Kumar Bhatia |
| Designation |
Professor and Head of Department |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
AIIMS Hospital, Basni phase-II,Jodhpur
Department of Anaesthesiology and Critical Care, AIIMS Jodhpur
Jodhpur
Rajasthan
342005
India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9829159665 |
| Fax |
|
| Email |
pk_bhatia@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep Kumar Bhatia |
| Designation |
Professor and Head of Department |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
AIIMS Hospital, Basni phase-II,Jodhpur
Department of Anaesthesiology and Critical Care, AIIMS Jodhpur
Jodhpur
Rajasthan
342005
India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9829159665 |
| Fax |
|
| Email |
pk_bhatia@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anjana Ramachandran |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Department of Anaesthesiology
3rd floor Operation Theatre
Aiims hospital Basni Phase-II, Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9961957533 |
| Fax |
|
| Email |
simplyanjuram@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Jodhpur |
| Address |
AIIMS Hospital,Basni Phase-2,Jodhpur Rajasthan 342005 India |
| 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 Pradeep Bhatia |
AIIMS Jodhpur |
Trauma block ground floor Emergency medicine casualty room
Jodhpur
RAJASTHAN |
0291-2740741
bhatiapk@aiimsjodhpur.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J470||Bronchiectasis with acute lower respiratory infection, (2) ICD-10 Condition: J441||Chronic obstructive pulmonary disease with (acute) exacerbation, (3) ICD-10 Condition: J459||Other and unspecified asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged above 18 yrs
Diagnosed case of any obstructive airway disease
Tachypnoeic (RR>20) and in need of oxygen therapy( ie.SPO2<92) recognised by clinician
|
|
| ExclusionCriteria |
| Details |
Pregnant women
Patients with severe respiratory failure requiring immediate tracheal intubation and mechanical ventilation
SPO2>92%
Obese patients and postoperative patients after upper abdominal surgery, where abdominal ultrasound could be difficult
Patients on continuous rhyles tube aspiration
Patients with any serious cardiovascular, renal or hepatic illnes
Patients with abnormalities of face or who are post surgery of face, nose or airway that preclude an appropriate fitting nasal cannula
Psychiatric, agitated or non-cooperative patients
Patients with altered sensorium
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe the prevalence of gastric insufflation at different flow rates of HFNO in a range of 40-60L/min in obstructive airway disease patients. |
30 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To observe the difference in gastric volume before and after application of HFNO in obstructive airway disease patients.
To detect the increase in peristaltic activity of gastric antrum,as a surrogate marker for gastric insufflation.
To observe the effect of HFNO on pulse rate, blood pressure,respiratory rate,SPO2,PaCO2,PaO2,PaO2/FiO2,SaO2 values of obstructive airway disease patients. |
30 min |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/04/2020 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
HFNO is being increasingly used these days in patients with acute and chronic respiratory failure as a useful alternative to conventional oxygen therapy and other noninvasive systems of respiratory support. We expect gastric insufflation to be present as a complication in patients of obstructive high airway resistance diseases, who use HFNO and quantify the distension according to different flows. All patients who are diagnosed to have obstructive airway diseases and is on conventional oxygen therapy will be enrolled in the study. After giving detailed description about the study that is being conducted and obtaining informed consent, a brief history of the patients who are enrolled for the study will be taken regarding relevant comorbidities and duration of repiratory illness and medications. Physiological data including vital signs such as heart rate, respiratory rate, blood pressure, pulse oxygen saturation and ABG values which include PaO2, PaCO2, PaO2/FiO2, SaO2 is recorded.Once the decision of HFNO therapy is made by the treating clinician, patient’s basal gastric volume is measured using ultrasonography.The average number of peristaltic contractions of stomach in one minute will be calculated after counting the epristaltic contractions for a time period of 5 minutes.Following this, HFNO therapy will be started as per the Department protocol, initial flow will be set at 40L/min and increased by 5L/min increments as tolerated by the patient and depending on respiratory rate and distress. FiO2 will be titrated so as to attain an SPO2>92 for the patient. A 2nd and 3rd ultrasound scan will be done respectively at 10 and 30 min after start of HFNO therapy. These scans will look for airleaks into stomach and any change in gastric volume. The average number of peristaltic contractions of stomach in one minute will be calculated after counting the peristaltic contractions for a time period of 5 minutes. The new vitals and ABG values are recorded after 30 minutes of start of therapy. Scans will be repeated at 10 min and 30 min whenever a change is made in the flow rates as part of HFNO therapy. The total duration of HFNO therapy and its outcome will also be recorded |