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

Completed

• Conditions: Critical Illness

• Registration Number: NCT05311007
• Lead Sponsor: Centre Hospitalier Régional d'Orléans

Brief 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.

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 Timeline

• Study First Submitted: 2022-03-23
• Study First Submitted QC: 2022-03-31
• Study First Posted: 2022-04-05
• Study Start: 2022-05-28
• Primary Completion: 2024-05-04
• Study Completion: 2024-05-04
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of severe adverse events during intra-hospital transport	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of minor adverse events during intra-hospital transport	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)

Trial Locations

Locations (4)

Hospital Center of DAX; 🇫🇷 DAX, France

CH de Martigues; 🇫🇷 Martigues, France

CHR d'ORLEANS; 🇫🇷 Orléans, France

CH Bretagne Atlantique vannes-Auray; 🇫🇷 Vannes, France