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

Evaluation of Oxygenation Methods and Non-invasive Ventilatory Support in Patients With Acute Respiratory Failure for Whom a Do-not Intubate Order Was Taken: Prospective Observational Study

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

Study Overview

• Status: Unknown
• Conditions: Cancer; Hematologic Malignancy; Acute Respiratory Failure; Chronic Respiratory Insufficiency; Cardiac Insufficiency
• Intervention / Treatment: Device: NFHC-O2; Device: NIV

Detailed 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

• Study Type: Observational
• Enrollment (Anticipated): 330

Contacts and Locations

Study Locations

• France
  • Poitiers, France, 86000
    • Recruiting
    • CHU de Poitiers
    • Contact: René ROBERT, MD,PhD; Phone Number: +335494443854; Email: rene.robert@chu-poitiers.fr
    • Contact: Céline DELETAGE, CRA; Phone Number: +335494443854; Email: celine.deletage@chu-poitiers.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
NFHC-O2 Group; NFHC-O2 therapy alone with gas flow at least 40L/min,	Device: NFHC-O2; 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	Device: NIV; 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,	Device: NFHC-O2; NFHC-O2 setting: minimal FiO2 0.3; minimal flow 40l/min; Device: NIV; NIV setting: minimal FiO2 0.3; tidal volume 6-8ml/kg (theoretical body weight)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival at day 14	Survival at day 14 in patients weaned from NIV and or HNFC-O2	day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical respiratory parameters evolution	respiratory rate improvement will be assessed by a decrease of respiratory rate below 20/min	day 1, day 2, day 3
Oxygenation parameters evolution	sPO2 (oxygen saturation) expressed in % improvement will be assessed by an increase above 92%	day 1, day 2, day 3
tolerance of technique of oxygenation	tolerance will be assessed by comfort visual analogic scale from 1 worse tolerance to 10 very good tolerance; improvement defined as a 20% decrease of the value	day 1, day 2, day 3
evolution of quality of life	quality of life will be measured by the EuroQuality of life 5D score (EQ5D) recording 5 subscore (mobility, autonomy, ability to perform current activities, pain, anxety/depression); the value of each is from 1 to 3 points; total score is the sum of the 5 subscores with a minimal score of 5 and a maximal score of 15. The baseline score will be recorded after admission in the ICU and reflects the patient's quality of life just before his or her admission. After 3 and 6 months, a higher value of the score will represent a worse outcome.	on admission and after 3 and 6 months after ICU stay
Acceptation of the non invasive technique	tolerance defined by the absence of refusal to continue the technique (NIV or HNFC O2) by the patient	day 14
mortality day 28	percentage of patients deceased at day 28 whatever the cause of death	day 28

Collaborators and Investigators

• Sponsor: Poitiers University Hospital
• Investigators: Study Director: René ROBERT, MD,PhD, Poitiers University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2018
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: August 2, 2018
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (Actual): September 17, 2018

Study Record Updates

• Last Update Posted (Actual): September 28, 2018
• Last Update Submitted That Met QC Criteria: September 27, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: palliative; non-invasive ventilation; acute respiratory failure; nasal high flow humidified canula oxygenation; withholding therapies; withdrawing therapies
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Neoplasms; Respiration Disorders; Lung Diseases; Neoplasms by Site; Hematologic Diseases; Heart Failure; Hematologic Neoplasms; Respiratory Insufficiency; Respiratory Distress Syndrome
• Other Study ID Numbers: OXY-PAL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No