Efficacy of Volume Ventilation in Patients With Acute Respiratory Failure at Risk of Obstructive Apneas or Obesity Hypoventilation

Obesity Clinical Trial

— VONIVOO  

Official title:

Efficacy of Volume Targeted Pressure Support Ventilation vs. Pressure Support Ventilation in Patients With Acute Respiratory Failure at Risk of Obstructive Apneas or Obesity Hypoventilation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04131660
• Other study ID #: 2018/409/HP
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Acidosis
• Acute Respiratory Failure
• Apnea
• Apnea, Obstructive
• Hypercapnia
• Hypercapnic Respiratory Failure
• Hypoventilation
• Hypoventilation Syndrome
• Obesity
• Respiratory Acidosis
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency
• Sleep Apnea, Obstructive

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