Comfort of Patients Under Non Invasive Ventilation According to the Mask

Acute Respiratory Failure Clinical Trial

— ComPaNIV  

Official title:

Comparison of the Comfort of Patients Under Non-invasive Ventilation According to the Use of a Sub Nasal Mask Versus an Oronasal Mask

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06212180
• Other study ID #: APHP231673
• Secondary ID: 2023-A02093-42
• Status: Not yet recruiting
• Start date: January 2024
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Christophe CARPENTIER, MD
• Phone: 0145217138
• Email: christophe.carpentier[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A sub-nasal mask with a skirt that fits the nostrils and with a dedicated port for the nasogastric tube has recently been introduced. This interface has never been compared to nasal-oral masks. We hypothesise that such a sub-nasal mask increases comfort compared to a conventional naso-oral mask. The primary objective is to compare the comfort of the sub-nasal mask with that of a standard naso-oral mask.

Description:

Non-invasive ventilation (NIV) is a first-line treatment for many conditions encountered in the ICU. This technique requires training of heath professionals, appropriate equipment, optimisation of ventilator settings and good cooperation from the patient. Indeed, NIV failures lead ton invasive mechanical ventilation, thus increasing morbidity and mortality. These failures are favoured by the patient's poor tolerance to NIV. The success of the treatment depends greatly on the patient's compliance and comfort. The choice of the mask is therefore essential. There are different types of interface, such as the full-face helmet, the face mask, the nasal-oral mask or the nasal mask. The nasal-oral mask rmains the most commonly used interface. Recommendations emphasise the importance of choosing a mask that is the right size and best tolerated by the patient. Despite benefits of NIV, there are a number of potential complications: skin lesions at pressure points, particulaly at the nasal bridge, gastric distension, barotrauma, haemodynamic effects of positive presure ventilation, claustrophobia, anxiety, difficulty in speaking and eating, dry eyes, patient-ventilator asynchrony. Some of these complications depend on the type of mask used. a sub-nasal mask with a skirt that fits the nostrils and a dedicated port for the nasogastric tube has recently been introduced. To our knowledge, this interface has never been compared to commercially avaible nasal-oral masks.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Indication of NIV, carried out by the physicians in charge of the patient, among the following:

• COPD exacerbation

• Hydrostatic acute pulmonary edema

• Acute Chest Syndrome with Hypercapnia in Sickle Cell Patients

• Post-extubation, planned in a patient at risk or recovering from extubation failure

• Hypoventilation-obesity syndrome

Exclusion Criteria:

Formal contraindication to NIV among:

• Indication for orotracheal intubation at the outset

• Non-cooperative, agitated, opponent of the technique

• Coma

• Respiratory exhaustion

• Shock, severe ventricular arrhythmias, immediate aftermath of cardiac arrest

• Undrained pneumothorax, blowing chest wound

• Upper airway obstruction (except sleep apnea, laryngotracheomalacia)

• Uncontrollable vomiting

• Upper gastrointestinal bleeding

• Measure of protection of justice

• Facial deformity

• Dying or palliative care patient

• Pregnancy

Related Conditions & MeSH terms

• Acute Respiratory Failure
• COPD Exacerbation
• Hypercapnia
• Hypoventilation
• Obesity Hypoventilation Syndrome
• Respiratory Insufficiency

Intervention

Device:
• mask
patients will be their own comparator. Patients will try both mask for 10 min and then decide which mask they want for the rest of the ventilation

Locations

Country	Name	City	State
France	Hôpital Henri Mondor - Réanimation/ Unité de Surveillance Continue	Créteil
France	CHU Bicêtre - USC	le Kremlin Bicetre
France	CHU Bicêtre - Unité de Soins Intensifs Pneumologique	Le Kremlin-Bicêtre

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1 to 10 self assessment scale	Comfort will be assessed by a numerical self-assessment scale from 0 to 10.	throughout the study (an average of 10 months)
Secondary	Percentage of subjects who prefer one type of mask over the other		throughout the study (an average of 10 months)
Secondary	Percentage of leakage volume compared to the tidal leakage volume		throughout the study (an average of 10 months)
Secondary	Dyspnea		throughout the study (an average of 10 months)
Secondary	Number of interventions on mask position by nurses during NIV session		throughout the study (an average of 10 months)
Secondary	Number of side effects		throughout the study (an average of 10 months)