Effect of prone positioning in patients with severe SARS-CoV-2 pneumonia treated with noninvasive ventilatio

Not Applicable

Completed

• Conditions: Moderate-to-severe acute hypoxemic respiratory failure due to COVID-19 pneumonia; Respiratory

• Registration Number: ISRCTN23016116
• Lead Sponsor: Ospedale Humanitas Gradenigo

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35488356/ (added 03/05/2022) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37232709/ (added 30/05/2023) 2023 Results article in https://doi.org/10.1007/s13167-023-00325-5 (added 19/07/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-02
• Study Completion: 2021-09-12
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

1. Presence of acute (i.e. symptom onset <14 days of hospital access) hypoxemic respiratory failure
2. Confirmed severe SARS-CoV-2 pneumonia based on the Center for Disease Control guidelines: SARS-CoV-2 infection confirmed by PCR AND bilateral opacities on chest X-ray or CT scan not fully explained by effusions, lobar or lung collapse, or nodules, with sO2<90% in room air on pulse oxymetry
4. Cardiac failure not the primary cause of acute respiratory failure
5. Moderate to severe hypoxemia, defined by a PaO2/FiO2 ratio <200 mm Hg while receiving oxygen therapy through either a Venturi mask with FiO2 50% or a non-rebreather reservoir bag-mask, with FiO2 estimated as 0.21+ oxygen flow rate in L/min×3

Exclusion Criteria

1. Age less than 18 years-old
2. Pregnancy
3. Immediate need of invasive mechanical ventilation (altered mental status, fatigue, hemodynamic instability).
4. Contraindications for prone positioning therapy (recent abdominal or thoracic surgery or wound; facial, pelvic, or spine fracture)
5. Vomiting or bowel obstruction
6. Palliative care
7. Multiorgan failure
8. Pneumothorax
9. Inability of the patient to provide informed consent
10. Uncooperativeness or refusal to lie on abdomen for at least 8 hours

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of NIV failure at 28 days, defined as the occurrence of endotracheal intubation (for those patients with a full treatment indication) OR death for those patients with a Do-Not-Intubate (DNI) order. This will be assessed by reviewing patient notes or in-presence or phone patient interview.