Comfort of Patients Under Non Invasive Ventilation According to the Mask

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jan 8, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how comfortable patients feel when using two different types of masks during non-invasive ventilation (NIV), which helps patients breathe better without needing a breathing tube. The study will compare a new sub-nasal mask, designed to fit snugly over the nostrils and accommodate a feeding tube, with a standard nasal-oral mask that covers the nose and mouth. The goal is to find out if the new mask is more comfortable for patients with conditions like COPD (chronic lung disease) or other serious breathing problems.

To participate in this trial, patients should be between the ages of 65 and 74 and must have certain breathing conditions that require non-invasive ventilation, such as worsening COPD or acute respiratory issues. However, some patients may not be eligible if they have severe medical conditions or other factors that would make using the mask unsafe. Participants will be monitored for their comfort level while using these masks, helping researchers understand which option is better for improving patient care. It's important to note that this trial has not yet started recruiting participants.

Gender

ALL

Eligibility criteria

• 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