Intrahospital Transport in Patients With High-flow Nasal Oxygenation: Prospective Observational Study

Critical Illness Clinical Trial

— HospiFlow  

Official title:

Intrahospital Transport in Patients With High-flow Nasal Oxygenation: Prospective Observational Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05311007
• Other study ID #: CHRO-2022-01
• Status: Recruiting
• Start date: May 29, 2022
• Est. completion date: June 2024

Study information

• Verified date: July 2023
• Source: Centre Hospitalier Régional d'Orléans
• Contact: Mai-Anh NAY, Dr
• Phone: 0033238575253
• Email: mai-anh.nay[@]chr-orleans.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness

Intervention

Other:
• Evaluation of the incidence and nature of adverse events
Evaluation of the incidence and nature of adverse events during intra-hospital transport of patients undergoing high-flow nasal oxygen therapy provided by intensive care units

Locations

Country	Name	City	State
France	Hospital Center of DAX	DAX
France	CH de Martigues	Martigues
France	CHR d'ORLEANS	Orléans
France	CH Bretagne Atlantique vannes-Auray	Vannes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional d'Orléans

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of severe adverse events during intra-hospital transport	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	Incidence of minor adverse events during intra-hospital transport	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