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

NCT ID: NCT03673631

Last Updated: 2018-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

330 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-07

Study Completion Date

2020-01-31

Brief Summary

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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

Detailed Description

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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

Conditions

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Acute Respiratory Failure Cancer Hematologic Malignancy Cardiac Insufficiency Chronic Respiratory Insufficiency

Keywords

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non-invasive ventilation nasal high flow humidified canula oxygenation palliative acute respiratory failure withholding therapies withdrawing therapies

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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NFHC-O2 Group

NFHC-O2 therapy alone with gas flow at least 40L/min,

NFHC-O2

Intervention Type DEVICE

NFHC-O2 setting: minimal FiO2 0.3; minimal flow 40l/min

NIV/Standard-O2 Group

NIV sessions with at least 30% FiO2 and standard oxygen therapy

NIV

Intervention Type DEVICE

NIV setting: minimal FiO2 0.3; tidal volume 6-8ml/kg (theoretical body weight)

NFHC-O2/NIV Group

combination of NIV sessions and NFHC-O2 therapy,

NIV

Intervention Type DEVICE

NIV setting: minimal FiO2 0.3; tidal volume 6-8ml/kg (theoretical body weight)

NFHC-O2

Intervention Type DEVICE

NFHC-O2 setting: minimal FiO2 0.3; minimal flow 40l/min

Interventions

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NIV

NIV setting: minimal FiO2 0.3; tidal volume 6-8ml/kg (theoretical body weight)

Intervention Type DEVICE

NFHC-O2

NFHC-O2 setting: minimal FiO2 0.3; minimal flow 40l/min

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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René ROBERT, MD,PhD

Role: STUDY_DIRECTOR

Poitiers University Hospital

Locations

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Chu de Poitiers

Poitiers, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Rene ROBERT, MD,PhD

Role: CONTACT

Phone: +335494443854

Email: [email protected]

Celine DELETAGE, CRA

Role: CONTACT

Phone: +335494443854

Email: [email protected]

Facility Contacts

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René ROBERT, MD,PhD

Role: primary

Céline DELETAGE, CRA

Role: backup

References

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Robert R, Frasca D, Badin J, Girault C, Guitton C, Djibre M, Beuret P, Reignier J, Benzekri-Llefevre D, Demiri S, Rahmani H, Argaud LA, I'her E, Ehrmann S, Lesieur O, Kuteifan K, Thouy F, Federici L, Thevenin D, Contou D, Terzi N, Nseir S, Thyrault M, Vinsonneau C, Audibert J, Masse J, Boyer A, Guidet B, Chelha R, Quenot JP, Piton G, Aissaoui N, Thille AW, Frat JP. Comparison of high-flow nasal oxygen therapy and non-invasive ventilation in ICU patients with acute respiratory failure and a do-not-intubate orders: a multicentre prospective study OXYPAL. BMJ Open. 2021 Feb 12;11(2):e045659. doi: 10.1136/bmjopen-2020-045659.

Reference Type DERIVED
PMID: 33579774 (View on PubMed)

Other Identifiers

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OXY-PAL

Identifier Type: -

Identifier Source: org_study_id