Acute Respiratory Failure, Cancer, Hematologic Malignancy, Cardiac Insufficiency, Chronic Respiratory Insufficiency
Conditions
Keywords
non-invasive ventilation, nasal high flow humidified canula oxygenation, palliative, acute respiratory failure, withholding therapies, withdrawing therapies
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
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
Interventions
DEVICENIV
NIV setting: minimal FiO2 0.3; tidal volume 6-8ml/kg (theoretical body weight)
DEVICENFHC-O2
NFHC-O2 setting: minimal FiO2 0.3; minimal flow 40l/min
Sponsors
Poitiers University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival at day 14 | day 14 | Survival at day 14 in patients weaned from NIV and or HNFC-O2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxygenation parameters evolution | day 1, day 2, day 3 | sPO2 (oxygen saturation) expressed in % improvement will be assessed by an increase above 92% |
| tolerance of technique of oxygenation | day 1, day 2, day 3 | 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 |
| Clinical respiratory parameters evolution | day 1, day 2, day 3 | respiratory rate improvement will be assessed by a decrease of respiratory rate below 20/min |
| Acceptation of the non invasive technique | day 14 | tolerance defined by the absence of refusal to continue the technique (NIV or HNFC O2) by the patient |
| mortality day 28 | day 28 | percentage of patients deceased at day 28 whatever the cause of death |
| evolution of quality of life | on admission and after 3 and 6 months after ICU stay | 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. |
Countries
France
Contacts
Primary ContactRene ROBERT, MD,PhD
Backup ContactCeline DELETAGE, CRA
Outcome results
None listed