Status:
COMPLETED
CPAP Therapy Through a Helmet or a Full Face Mask in Patients With Acute Hypoxemic Respiratory Failure: Cross-over Study
Lead Sponsor:
I.M. Sechenov First Moscow State Medical University
Conditions:
Pneumonia, Bacterial
Respiratory Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Observational and randomized trials have demonstrated the high effectiveness of non-invasive helmet ventilatory support, demonstrating a reduction in intubation rate mortality compared with high-flow ...
Detailed Description
In December 2019, an outbreak of a novel coronavirus emerged in Wuhan, China and rapidly spread worldwide. The World Health Organization (WHO) declared the outbreak a pandemic on March 11th, 2020. The...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06113432
Start Date
September 19 2023
End Date
May 30 2024
Last Update
June 18 2024
Active Locations (1)
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1
City clinical hospital named after F.I.Inozemtsev, Moscow
Moscow, Russia, 105187