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

Sponsor
Centre Hospitalier Régional d'Orléans (Other)
Overall Status
Recruiting
CT.gov ID
NCT05311007
Collaborator
(none)
200
4
24.1
50
2.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Evaluation of the incidence and nature of adverse events

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Intrahospital Transport in Patients With High-flow Nasal Oxygenation: Prospective Observational Study.
Actual Study Start Date :
May 29, 2022
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Center of DAX DAX France
2 CH de Martigues Martigues France
3 CHR d'ORLEANS Orléans France
4 CH Bretagne Atlantique vannes-Auray Vannes France 56017

Sponsors and Collaborators

  • Centre Hospitalier Régional d'Orléans

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Régional d'Orléans
ClinicalTrials.gov Identifier:
NCT05311007
Other Study ID Numbers:
  • CHRO-2022-01
First Posted:
Apr 5, 2022
Last Update Posted:
Jul 18, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Régional d'Orléans
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 18, 2022