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

Study Overview
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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

Official Title
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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

Conditions
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Cancer, Acute Respiratory Failure, Hematologic Malignancy, Cardiac Insufficiency, Chronic Respiratory Insufficiency

Intervention / Treatment
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* Device: NIV
* Device: NFHC-O2


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NFHC-O2 Group<br>NFHC-O2 therapy alone with gas flow at least 40L/min, | Device: NFHC-O2<br>* NFHC-O2 setting: minimal FiO2 0.3; minimal flow 40l/min<br>|
| NIV/Standard-O2 Group<br>NIV sessions with at least 30% FiO2 and standard oxygen therapy | Device: NIV<br>* NIV setting: minimal FiO2 0.3; tidal volume 6-8ml/kg (theoretical body weight)<br>|
| NFHC-O2/NIV Group<br>combination of NIV sessions and NFHC-O2 therapy, | Device: NIV<br>* NIV setting: minimal FiO2 0.3; tidal volume 6-8ml/kg (theoretical body weight)<br>Device: NFHC-O2<br>* NFHC-O2 setting: minimal FiO2 0.3; minimal flow 40l/min<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-invasive ventilation, nasal high flow humidified canula oxygenation, palliative, acute respiratory failure, withholding therapies, withdrawing therapies