Alternate use of intermittent high flow nasal cannula (HFNC) and noninvasive ventilation (NIV) on the improvement of ventilation status of patients in intensive care units.
Achieving a protocol for the use of high-flow oxygen through the nose (HFNC) and non-invasive ventilation (NIV) in icu patients.
Design
Clinical trial, community-based and pragmatic, factorial group, not blinded.
Settings and conduct
This study was conducted in the Masih Daneshvari Hospital, Mashhad, Iran. Patients requiring high-flow oxygenation were included in the study. This study will continue for six months and will be available to patients for intermittent and, if necessary, NIV and HFLN will be used.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients have an indication of Oxygenation high and non-invasive flow, Age more than 18
Exclusion criteria: NHFL patient intolerance, Advanced cancer patients,
Advanced ESRD patients, Patients with pericardial effusion.
Intervention groups
150 patients alternating in the group receiving high flow nasal cannula and non invasive ventlation.
Main outcome variables
Interpretation of arterial blood gas
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150107020592N20
Registration date:2019-02-10, 1397/11/21
Registration timing:retrospective
Last update:2019-02-10, 1397/11/21
Update count:0
Registration date
2019-02-10, 1397/11/21
Registrant information
Name
Seyed Mohammad Reza Hashemian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2610 9944
Email address
iran.criticalcare@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-01, 1397/05/10
Expected recruitment end date
2019-01-29, 1397/11/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Alternate use of intermittent high flow nasal cannula (HFNC) and noninvasive ventilation (NIV) on the improvement of ventilation status of patients in intensive care units.
Public title
Alternate use of intermittent high flow nasal cannula (HFNC) and noninvasive ventilation (NIV) in intentionally critical care cases.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients have an indication of Oxygenation high and non-invasive flow
Age more than 18
Exclusion criteria:
NHFL patient intolerarnce
Advanced cancer patients
Advanced ESRD patients
Patients with pericardial effusion
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Masih Daneshvari Hospital the Edjucational , Research and Treatment center.
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Approval date
2018-08-14, 1397/05/23
Ethics committee reference number
IR.SBMU.NRITLD.REC.1397.044
Health conditions studied
1
Description of health condition studied
Pneomunia
ICD-10 code
J18.0
ICD-10 code description
Bronchopneumonia, unspecified organism
2
Description of health condition studied
Acute respiratory distress syndrome (ARDS)
ICD-10 code
J80
ICD-10 code description
Acute respiratory distress syndrome
3
Description of health condition studied
Respiratory tuberculosis
ICD-10 code
A15
ICD-10 code description
Respiratory tuberculosis
4
Description of health condition studied
Sepsis
ICD-10 code
A41.9
ICD-10 code description
Sepsis, unspecified organism
Primary outcomes
1
Description
Interpretation of arterial blood gas
Timepoint
Before and after
Method of measurement
Arterial blood gas
Secondary outcomes
1
Description
PCO2
Timepoint
Before and after
Method of measurement
Arterial blood gas
2
Description
PO2
Timepoint
Before and after
Method of measurement
Arterial blood gas
3
Description
Staying time in ICU
Timepoint
Before and after
Method of measurement
Assessment of patient's document
Intervention groups
1
Description
First intervention group: Patient recipients high flow nasal cannula . The selected patients receive 24 hours of HFNC 8 hours and then NIV 4 hours, again 4 hours of HFNC and then NIV 8 hours.
Category
Treatment - Devices
2
Description
Second intervention group: Patient recipients noninvasive ventilation. The selected patients receive 24 hours of NIV 8 hours and then NHFC 4 hours, again 4 hours of NIV and then NHFC 8 hours.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Dr. Seyyed Mohammadreza Hashemian
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran