- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05311007
Intrahospital Transport in Patients With High-flow Nasal Oxygenation: Prospective Observational Study (HospiFlow)
Intrahospital Transport in Patients With High-flow Nasal Oxygenation: Prospective Observational Study.
High-flow nasal oxygen therapy is commonly used in intensive care unit (ICU). Intra-hospital transfer of critical patients is frequent: 1) to perform diagnostic 2) between emergency room or medical wards and ICU. During theses transfers, oxygenation should be continued.
There is high-flow nasal oxygen therapy for transport using an external battery. This mode of operation in transport mode allows about 30-45 min of autonomy.
Intra-hospital transport under high-flow nasal oxygen therapy has been previously described on children.
The objective of this study is to evaluate the occurrence of complications during intra-hospital transports under high-flow nasal oxygen of critical patients.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
High-flow nasal oxygen therapy is commonly used in intensive care unit (ICU). Intra-hospital transfer of critical patients is frequent: 1) to perform diagnostic 2) between emergency room or medical wards and ICU. During theses transfers, oxygenation should be continued.
There is high-flow nasal oxygen therapy for transport using an external battery. This mode of operation in transport mode allows about 30-45 min of autonomy.
Intra-hospital transport under high-flow nasal oxygen therapy has been previously described on children.
The objective of this study is to evaluate the occurrence of complications during intra-hospital transports under high-flow nasal oxygen of critical patients.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Dax, France
- Hospital Center of DAX
-
Martigues, France
- CH de Martigues
-
Orléans, France, 45067
- CHU Orléans
-
Vannes, France, 56017
- CH Bretagne Atlantique Vannes-Auray
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient treated with high-flow nasal oxygen therapy before the intra-hospital transport prior to transport
- Requiring an intra-hospital transport (e.g., CT scan, OR, etc.) or inter-departmental transport supervised by the ICU team
Nb: Once the patient is included in the study, any intra-hospital transport under high-flow nasal oxygen therapy will be analyzed until discharge from the intensive care unit and at until D28.
Exclusion Criteria:
- Under 18 years old
- Patient being under guardianship, tutorship or curatorship
- Pregnancy or breastfeeding
- Lack of social security number
- Refusal to participate in the study
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of severe adverse events during intra-hospital transport
Time Frame: Up to 28 days
|
To evaluate the incidence of severe adverse events during intra-hospital transport of patients treated with high-flow nasal oxygen surpervised by an ICU staff. Severe adverse event is defined by the occurrence of intubation during transport or severe hypoxemia defined as pulse oxygen saturation (SpO2 < 80%) or cardiorespiratory arrest. |
Up to 28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of minor adverse events during intra-hospital transport
Time Frame: Up to 28 days
|
To evaluate the incidence of minor adverse events during intra-hospital transport of patients treated with high-flow nasal oxygen surpervised by an ICU staff. Minor adverse event is defined by the occurrence of the need to increase the FiO2 or a pull-out of nasal cannulas or the use of an alternative mode of oxygenation (standard oxygen or noninvasive ventilation) or a failure of high-flow nasal oxygenation system (ie battery failure) |
Up to 28 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Mai-Anh NAY, Dr, CHU d'Orléans
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHRO-2022-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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