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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04131660
Other study ID # 2018/409/HP
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 30, 2019
Est. completion date December 2020

Study information

Verified date October 2019
Source University Hospital, Rouen
Contact Maxime Patout, MD
Phone 0033232889083
Email maxime.patout@chu-rouen.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study compares a volume targeted pressure support non-invasive ventilation with an automatic PEP regulation (AVAPS-AE mode) to a pressure support non-invasive ventilation (S/T mode) in patients with acute hypercapnic respiratory failure with acidosis. This study focuses on patients at risk of obstructive apneas or obesity-hypoventilation syndrom (BMI≥30 kg/m²). Half of participants (33 patients) will receive non invasive ventilation with AVAPS-AE mode, the other half will receive non-invasive ventilation with S/T mode.


Description:

So far, in respiratory intensive care units, the usual treatment of patients with acute hypercapnic respiratory failure with acidosis is non-invasive ventilation set with a pressure support mode (S/T or VS/AI mode depending on the ventilator manufacturer).

AVAPS-AE mode is a volume targeted pressure support mode with an automatic PEP. With the forced oscillations method, the ventilator is able to detect the obstruction and the resistances of upper airways.

It allows the ventilator to change its pressure settings to keep the targeted volume and avoid apneas and hypoventilation.

That is why in patients with a BMI > 30 kg/m², at risk of obesity hypoventilation syndrom or obstructive apneas, this ventilation mode may be interesting.

AVAPS-AE has been evaluated in the home ventilation showing it is as efficient as S/T mode in controlling PaCO2.

However it has never been compared to S/T mode in acute respiratory failure care.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 66
Est. completion date December 2020
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient of age

- Patient benefitting of social security

- Informed patient who signed the information note and the research enlighted consent form

- Admission in respiratory intensive care unit for an acid-hypercapnic exacerbation (defined by pH= 7,35)

- BMI = 30kg/m2

- PaCO2 > 6.5 kPa on blood gases at ICU admission

Exclusion Criteria:

- Confirmed COPD with a spirometry (VEMS/CVF < 70%)

- Pregnant women, or breast-feeding women

- Patient with a judiciary or administrative liberty deprivation

- Patients under guardianship

- Contraindication to NIV

Study Design


Intervention

Device:
AVAPS-AE mode during NIV
NIV will be setup in AVAPS-AE mode, with a Trilogy ventilation device (Respironics, Murrysville, PA). The range of positive expiratory pressure will be set between 4 and 14 cmH2O. The range of inspiratory pressure support will be set between 14 and 24 cmH2. The target tidal volume will be set to achieve 8 to 10 mL/kg of ideal body weight (Size (m) * Size (m) * 23).
S/T mode during NIV
NIV will be setup in ST mode, with a Trilogy ventilation device (Respironics, Murrysville, PA). The physician will decide the level of positive expiratory pressure and of pressure support.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Rouen

Outcome

Type Measure Description Time frame Safety issue
Primary Resolution of hypercapnia Time between admission and resolution of hypercapnia (= 6.5 kPa) through study completion, an average of 1 year
Secondary Comparison of persistent apneic events on NIV (/h) during the first night Comparison of persistent apneic events on NIV (/h) during the first night (determined with a respiratory polygraph) between S/T mode arm and AVAPS-AE mode arm (determined with an oxymeter) through study completion, an average of 1 year
Secondary Comparison of patient-ventilator asynchronisms during NIV (/h) Comparison of patient-ventilator asynchronisms during NIV (/h) between S/T mode arm and AVAPS-AE mode arm (determined with ventilator datas and a respiratory polygraph) through study completion, an average of 1 year
Secondary Comparison of time during NIV with a oxygen saturation below 90% Comparison of time during NIV with a oxygen saturation below 90% between S/T mode arm and AVAPS-AE mode arm (determined with an oxymeter) through study completion, an average of 1 year
Secondary Comparison of NIV confort Comparison of NIV confort between S/T mode arm and AVAPS-AE mode arm (NIV confort determined by a visual scale: 0: very comfortable to 10:not comfortable at all) through study completion, an average of 1 year
Secondary Comparison of length of stay Comparison of length of stay between S/T mode arm and AVAPS-AE mode arm through study completion, an average of 1 year
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