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

Cancer Clinical Trial

— OXYPAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03673631
• Other study ID #: OXY-PAL
• Status: Recruiting
• Start date: August 7, 2018
• Est. completion date: January 2020

Study information

• Verified date: August 2018
• Source: Poitiers University Hospital
• Contact: Rene ROBERT, MD,PhD
• Phone: +335494443854
• Email: rene.robert[@]chu-poitiers.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Cancer
• Cardiac Insufficiency
• Chronic Respiratory Insufficiency
• Heart Failure
• Hematologic Malignancy
• Pulmonary Valve Insufficiency
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

Device:
• NIV
NIV setting: minimal FiO2 0.3; tidal volume 6-8ml/kg (theoretical body weight)
• NFHC-O2
NFHC-O2 setting: minimal FiO2 0.3; minimal flow 40l/min

Locations

Country	Name	City	State
France	Chu de Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival at day 14	Survival at day 14 in patients weaned from NIV and or HNFC-O2	day 14
Secondary	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
Secondary	Oxygenation parameters evolution	sPO2 (oxygen saturation) expressed in % improvement will be assessed by an increase above 92%	day 1, day 2, day 3
Secondary	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
Secondary	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
Secondary	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
Secondary	mortality day 28	percentage of patients deceased at day 28 whatever the cause of death	day 28