NCT03673631

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
330

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

August 7, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 17, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

September 28, 2018

Status Verified

August 1, 2018

Enrollment Period

1.4 years

First QC Date

August 2, 2018

Last Update Submit

September 27, 2018

Conditions

Acute Respiratory FailureCancerHematologic MalignancyCardiac InsufficiencyChronic Respiratory Insufficiency

Keywords

non-invasive ventilationnasal high flow humidified canula oxygenationpalliativeacute respiratory failurewithholding therapieswithdrawing therapies

Outcome Measures

Primary Outcomes (1)

  • Survival at day 14

    Survival at day 14 in patients weaned from NIV and or HNFC-O2

    day 14

Secondary Outcomes (6)

  • Clinical respiratory parameters evolution

    day 1, day 2, day 3

  • Oxygenation parameters evolution

    day 1, day 2, day 3

  • tolerance of technique of oxygenation

    day 1, day 2, day 3

  • evolution of quality of life

    on admission and after 3 and 6 months after ICU stay

  • Acceptation of the non invasive technique

    day 14

  • +1 more secondary outcomes

Study Arms (3)

NFHC-O2 Group

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

Device: NFHC-O2

NIV/Standard-O2 Group

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

Device: NIV

NFHC-O2/NIV Group

combination of NIV sessions and NFHC-O2 therapy,

Device: NIVDevice: NFHC-O2

Interventions

NIVDEVICE

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

NFHC-O2/NIV GroupNIV/Standard-O2 Group
NFHC-O2DEVICE

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

NFHC-O2 GroupNFHC-O2/NIV Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* patient admitted in ICU or intermediate care with decision of a do-not intubate order on admission or after extubation (for patients receiving invasive mechanical ventilation) * with acute respiratory failure criteria (respiratory rate \>25/min; contraction of accessory respiratory muscles or hypoxemia requiering \> 3L/min O2 to obtain SpO2 \>92%) * and having indication for NIV or HFNC-O2

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu de Poitiers

Poitiers, 86000, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33579774DERIVED

MeSH Terms

Conditions

NeoplasmsHematologic NeoplasmsHeart Failure

Condition Hierarchy (Ancestors)

Neoplasms by SiteHematologic DiseasesHemic and Lymphatic DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • René ROBERT, MD,PhD

    Poitiers University Hospital

    STUDY DIRECTOR

Central Study Contacts

Rene ROBERT, MD,PhD

CONTACT

+335494443854rene.robert@chu-poitiers.fr

Celine DELETAGE, CRA

CONTACT

+335494443854celine.deletage@chu-poitiers.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2018

First Posted

September 17, 2018

Study Start

August 7, 2018

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

September 28, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)