Our study aims to assess the predictive validity of the HACOR score in our demographic area for diagnosing non-invasive ventilation (NIV) failure in patients diagnosed with type-1 respiratory failure assessed after one hour of NIV therapy irrespective of the cause of respiratory failure.
Design
Prospective, single center, single blinded, interventional study
Settings and conduct
HACOR score to be assessed by the consultant on duty one hour before and after being on CPAP therapy blinded to the study protocol
Participants/Inclusion and exclusion criteria
Inclusion criteria included patients with Pa02/FiO2 levels < 300 mmHg and PaCO2 levels less than 45 mmHg with PaO2 and PaCO2 (calculated by ABG (arterial blood gas) analysis) at room air or not maintaining ratio at low oxygenation therapy after administration of oxygen at FiO2 of 0.30
Exclusion criteria included patients with severe cardiorespiratory compromise, critical patients on vasopressor support, patients with poor lung compliance unable to breath in CPAP, intubated patients or those intubated less than 1 hour of CPAP, patients with a previous failed CPAP trial or on HFNO (high flow nasal oxygenation) in the last 72 hours, patients non-compliant on CPAP despite sedation and patients not willing to be included in the study.
Intervention groups
One interventional group studies for the HACOR score and its predictive validity for NIV failure before and after one hour on CPAP therapy
Main outcome variables
Primary variables studied were success and failure of CPAP therapy and accuracy of prediction of the HACOR score for NIV failure after 1 hour of therapy.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231101059927N1
Registration date:2023-11-07, 1402/08/16
Registration timing:retrospective
Last update:2023-11-07, 1402/08/16
Update count:0
Registration date
2023-11-07, 1402/08/16
Registrant information
Name
Ali Aftab
Name of organization / entity
PNS Shifa Hospital Karachi
Country
Pakistan
Phone
+92 300 2509354
Email address
alijiwani512@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-01, 1401/09/10
Expected recruitment end date
2023-09-30, 1402/07/08
Actual recruitment start date
2022-12-01, 1401/09/10
Actual recruitment end date
2023-09-30, 1402/07/08
Trial completion date
2023-09-30, 1402/07/08
Scientific title
Using HACOR score in predicting failure of non-invasive ventilation in patient with Type-I respiratory failure
Public title
HACOR score in predicting non-invasive ventilation failure
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Pa02/FiO2 levels < 300 mmHg and PaCO2 levels less than 45 mmHg with PaO2 and PaCO2 (calculated by ABG (arterial blood gas) analysis) at room air or not maintaining ratio at low oxygenation therapy after administration of oxygen at FiO2 of 0.30
Exclusion criteria:
Patients with severe cardiorespiratory compromise
Critical patients on vasopressor support
Patients with poor lung compliance unable to breath in CPAP
Intubated patients or those intubated less than 1 hour of CPAP
Patients with a previous failed CPAP trial or on HFNO (high flow nasal oxygenation) in the last 72 hours
Patients non-compliant on CPAP despite sedation
Patients unwilling to be included in the study
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
Investigator
Sample size
Target sample size:
180
Actual sample size reached:
180
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinded of the study protocol and given a standard monitoring chart to endorse vitals and clinical variables to be later assessed by the outcome assessor
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Review Board PNS Shifa Karachi
Street address
PNS Shifa
City
Karachi
Postal code
75300
Approval date
2022-11-30, 1401/09/09
Ethics committee reference number
PNS-KCI-00100
Health conditions studied
1
Description of health condition studied
Type-I respiratory failure
ICD-10 code
J96.0
ICD-10 code description
Acute respiratory failure
Primary outcomes
1
Description
Failure of NIV after 1-hour on CPAP therapy
Timepoint
1 hour after CPAP therapy
Method of measurement
Standard HACOR score
2
Description
Sensitivity and specificity of HACOR in predicting NIV failure
Timepoint
1 hour after being on CPAP therapy
Method of measurement
Assessment using standard SPSS software
3
Description
Postive and negative predictive value of the HACOR test in assessing NIV failure
Timepoint
1 hour after being on CPAP therapy
Method of measurement
Standard statistical SPSS software
Secondary outcomes
1
Description
Heart rate and mean arterial pressure
Timepoint
Before and after 1 hour of CPAP therapy
Method of measurement
Cardiac monitor
2
Description
Respiratory rate
Timepoint
Before and after 1 hour of CPAP therapy
Method of measurement
Standard respiratory monitor
3
Description
Glasgow coma scale
Timepoint
Before and after 1 hour of CPAP therapy
Method of measurement
Standard Glasgow coma scale
4
Description
Pa02/FiO2 ratio
Timepoint
Before and after 1 hour of CPAP therapy
Method of measurement
Using arterial blood gas samples and standard calculating formula
Intervention groups
1
Description
Intervention group: HACOR SCORE GROUP
Category
Early detection
Recruitment centers
1
Recruitment center
Name of recruitment center
PNS Shifa Karachi
Full name of responsible person
Dr Ali Aftab
Street address
PNS Shifa
City
Karachi
Postal code
64200
Phone
+92 300 2509354
Email
alijiwani512@hotmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
PNS Shifa Karachi
Full name of responsible person
Dr Ali Aftab
Street address
PNS Shifa
City
Karachi
Postal code
64200
Phone
+92 300 2509354
Email
alijiwani512@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
PNS Shifa Karachi
Proportion provided by this source
1
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
PNS Shifa Hospital Karachi
Full name of responsible person
Ali Aftab
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Critical care medicine
Street address
Dha phase 2
City
Karachi
Province
Sindh
Postal code
24700
Phone
+92 300 2509354
Fax
Email
alijiwani512@hotmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
PNS Shifa Hospital Karachi
Full name of responsible person
Ali Aftab
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Critical care medicine
Street address
Dha phase 2
City
Karachi
Province
Sindh
Postal code
24700
Phone
+92 300 2509354
Fax
Email
alijiwani512@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
PNS Shifa Hospital Karachi
Full name of responsible person
Ali Aftab
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Critical care medicine
Street address
Dha phase 2
City
Karachi
Province
Sindh
Postal code
24700
Phone
+92 300 2509354
Fax
Email
alijiwani512@hotmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Word document of the manuscript along with output sheet of SPSS software would be made available
When the data will become available and for how long
After acceptance for publication, data will be available online indefinitely
To whom data/document is available
Academic and research institutes only
Under which criteria data/document could be used
For research, academic and teaching purposes only
From where data/document is obtainable
Will be available online through google drive
What processes are involved for a request to access data/document
A written request to the primary author and the institute training branch and after acceptance and permission data would be made available in the next 5 working days and a temporary google drive link will be shared to download the data in the next one week