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Oxygenation Methods and Non-invasive Ventilation in Patients With Acute Respiratory Failure and a do Not Intubate Order (OXYPAL)

P

Poitiers University Hospital

Status

Unknown

Conditions

Hematologic Malignancy
Chronic Respiratory Insufficiency
Cancer
Cardiac Insufficiency
Acute Respiratory Failure

Treatments

Device: NIV
Device: NFHC-O2

Study type

Observational

Funder types

Other

Identifiers

NCT03673631
OXY-PAL

Details and patient eligibility

About

ICU care of patients considered "palliative" but without contraindications to admission to intensive care, for whom a do-not intubate order decision was made upon admission represents a particular target for non-invasive oxygenation techniques. The benefits of non invasive ventilation (NIV) in this population are debated especially in cancer patients. The more recently used nasal humidified high flux canula oxygenation (HFNC) therapy may have benefits over NIV in these patients. It is supposed to have better tolerance and could allow better compliance and thus higher efficiency. These potential benefits are major for such a population for which tolerance and symptomatic relief are priority goals

Full description

Observational prospective multicenter study Primary outcome: To analyze the efficacy and tolerance of NIV and HFNC in patients admitted to intensive care unit, or intermediate catre unit for acute respiratory insufficiency for whom a a do-not intubate order decision was taken upon admission or after extubation if the patient initially received mechanical ventilation.

Secondary outcomes: To analyze the efficacy and tolerance of NIV and HFNC according to the following reason for ICU admission: chronic obstructive pneumopathy decompensated COPD, severe heart failure, evolutive cancer or hematologic malignancy; to analyze tolerance and acceptability of different techniques; to analyze the duration of the oxygenation methods use; to analyze the modalities of eventual withdrawing life support therapies and the associated sedative and opioid treatments; to analyze the satisfaction for the use of the non invasive technique by the relatives and the caregivers; to analyze mortality at D28 and D90 and quality of life at 3 and 6 months in surviving patients

Enrollment

330 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • acute respiratory failure defined by respiratory rate>25/min and or hypoxemia (sPO2 <92% with O2 >3l/min)
  • admission in ICU or intermediate care unit
  • decision to not intubate the patient or to not re-intubate the patient
  • indication to NIV or HFNC-O2
  • French social security affiliation

Exclusion criteria

  • refusal to participate
  • legal protection
  • pregnancy
  • prophylactic treatment by VNI or HFNC-O2 after extubation

Trial design

330 participants in 3 patient groups

NFHC-O2 Group
Description:
NFHC-O2 therapy alone with gas flow at least 40L/min,
Treatment:
Device: NFHC-O2
NIV/Standard-O2 Group
Description:
NIV sessions with at least 30% FiO2 and standard oxygen therapy
Treatment:
Device: NIV
NFHC-O2/NIV Group
Description:
combination of NIV sessions and NFHC-O2 therapy,
Treatment:
Device: NIV
Device: NFHC-O2

Trial contacts and locations

1

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Central trial contact

Celine DELETAGE, CRA; Rene ROBERT, MD,PhD

Data sourced from clinicaltrials.gov

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