Comfort of Patients Under Non Invasive Ventilation According to the Mask

NCT06212180 | Unknown

• 2 other identifiers: APHP2316732023-A02093-42
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

COPD Exacerbation; Hypercapnia; Hypoventilation Obesity Syndrome; Acute Respiratory Failure

Keywords

Non-invasive ventilation; Acute respiratory failure; Comfort

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Percentage of subjects who prefer one type of mask over the other

  throughout the study (an average of 10 months)

• Percentage of leakage volume compared to the tidal leakage volume

  throughout the study (an average of 10 months)

• Dyspnea

  throughout the study (an average of 10 months)

• Number of interventions on mask position by nurses during NIV session

  throughout the study (an average of 10 months)

• Number of side effects

  throughout the study (an average of 10 months)

Interventions

mask DEVICE

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

Also known as: oronasal mask or subnasal mask

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients hospitalized in intensive care, continuous monitoring unit or pulmonary intensive care with an indication for NIV.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (3)

Hôpital Henri Mondor - Réanimation/ Unité de Surveillance Continue

Créteil, France

Location

CHU Bicêtre - Unité de Soins Intensifs Pneumologique

Le Kremlin-Bicêtre, 94270, France

Location

CHU Bicêtre - USC

Le Kremlin-Bicêtre, 94270, France

Location

MeSH Terms

Conditions

Hypercapnia; Obesity Hypoventilation Syndrome

Interventions

Masks

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Hypoventilation; Respiratory Insufficiency; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Surgical Attire; Equipment and Supplies, Hospital; Equipment and Supplies; Protective Devices; Personal Protective Equipment; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Christophe CARPENTIER, MD

  Assistance Publique - Hôpitaux de Paris, Hôpital Bicêtre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christophe CARPENTIER, MD

CONTACT

0145217138; christophe.carpentier@aphp.fr

Tai PHAM, MD

CONTACT

0145217138; tai.pham@aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 18, 2024
• Study Start: January 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 18, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)