CPAP Therapy Through a Helmet or a Full Face Mask in Patients With Acute Hypoxemic Respiratory Failure: Cross-over Study
ClinicalTrials.gov; 27/10/2023; TrialID: NCT06113432
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06113432
ABSTRACT
Condition
Pneumonia, Bacterial;Respiratory Failure;COVID-19 PneumoniaIntervention
Diagnostic Test Arterial blood gases;Diagnostic Test Respiratory rate (RR);Diagnostic Test Pulseoximeter;Diagnostic Test Assessment of accessory respiratory muscles work;Diagnostic Test Esophageal pressure measurement;Diagnostic Test Discomfort Visual Analog Scale (VAS);Diagnostic Test Noninvasive blood pressure;Diagnostic Test Heart ratePrimary outcome:
Inspiratory effort;Inspiratory delta transpulmonary pressure (stress);Expiratory delta transpulmonary pressureCriteria
Inclusion Criteria
- Patients with acute hypoxemic respiratory failure due to community-acquired pneumonia
or COVID-19
- The ratio of the partial pressure of oxygen in arterial blood to the inspiratory
fraction of oxygen (PaO2/FiO2) is less than 250 mm Hg while breathing atmospheric air
- Respiratory rate more than > 25 per minute.
- Written informed consent
Exclusion Criteria
- Patients who achieve the following target parameters with only low-flow oxygen therapy
(flow up to 15 l/min) SpO2 > 93%, the patient does not have a subjective feeling of
fatigue, there is no visible work of the auxiliary respiratory muscles of the neck,
- Unstable hemodynamics (systolic blood pressure <90 mm Hg or mean arterial pressure <65
mm Hg) and/or lactic acidosis (lactate >5 mmol/l and/or clinically diagnosed shock)
and/or life-threatening arrhythmia,
- Metabolic acidosis (pH <7.30);
- Patients who were in the ICU for less than 24 hours for any reason
- Primary or secondary lung diseases (exacerbation of chronic obstructive pulmonary
disease (COPD), bronchial asthma, interstitial lung diseases, metastatic lung disease)
- Cardiogenic pulmonary edema,
- Chronic diseases in the stag e of decompensation with the development of
extrapulmonary organ dysfunction (liver cirrhosis, progression of cancer, CHF),
- Glasgow Coma Scale score <14 points,
- Swallowing disorders
- Hypercapnia (PaCO2>45 mmHg),
- The need for urgent tracheal intubation for any reason,
- Recent head surgery or anatomy that prevents the placement of a helmet or full face
mask on the patient,
- Pregnancy,
- Inability to cooperate with staff
Collection:
Clinical trial registers
Database:
ICTRP
Year:
2023
Document Type:
Clinical Trial Register
Similar
MEDLINE
...
LILACS
LIS