Status:

UNKNOWN

Comfort of Patients Under Non Invasive Ventilation According to the Mask

Lead Sponsor:

Assistance Publique - Hôpitaux de Paris

Conditions:

COPD Exacerbation

Hypercapnia

Eligibility:

All Genders

18+ years

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 hyp...

Detailed 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 ven...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 1 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 1 2024

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT06212180

Start Date

January 1 2024

End Date

December 1 2024

Last Update

January 18 2024

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Hôpital Henri Mondor - Réanimation/ Unité de Surveillance Continue

Créteil, France

2

CHU Bicêtre - Unité de Soins Intensifs Pneumologique

Le Kremlin-Bicêtre, France, 94270

3

CHU Bicêtre - USC

Le Kremlin-Bicêtre, France, 94270

Comfort of Patients Under Non Invasive Ventilation According to the Mask | DecenTrialz