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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NFHC-O2 Group | NFHC-O2 therapy alone with gas flow at least 40L/min, |
| |
| NIV/Standard-O2 Group | NIV sessions with at least 30% FiO2 and standard oxygen therapy |
| |
| NFHC-O2/NIV Group | combination of NIV sessions and NFHC-O2 therapy, |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIV | Device | NIV setting: minimal FiO2 0.3; tidal volume 6-8ml/kg (theoretical body weight) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival at day 14 | Survival at day 14 in patients weaned from NIV and or HNFC-O2 | day 14 |
| 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% |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rene ROBERT, MD,PhD | Contact | +335494443854 | rene.robert@chu-poitiers.fr | |
| Celine DELETAGE, CRA | Contact | +335494443854 | celine.deletage@chu-poitiers.fr |
| Name | Affiliation | Role |
|---|---|---|
| René ROBERT, MD,PhD | Poitiers University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu de Poitiers | Recruiting | Poitiers | 86000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33579774 | Derived | 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. |
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| NFHC-O2 | Device | NFHC-O2 setting: minimal FiO2 0.3; minimal flow 40l/min |
|
| 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 |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D019337 | Hematologic Neoplasms |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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