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Clinical Trials/ISRCTN23016116
ISRCTN23016116
Completed
未知

Effect of prolonged prone positioning on intubation rate and mortality in noninvasively ventilated patients with SARS-CoV-2 pneumonia and moderate-to-severe hypoxemic respiratory failure: a controlled trial

Ospedale Humanitas Gradenigo0 sites138 target enrollmentJune 2, 2021
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ConditionsModerate-to-severe acute hypoxemic respiratory failure due to COVID-19 pneumoniaRespiratory

Overview

Phase
未知
Intervention
Not specified
Conditions
Moderate-to-severe acute hypoxemic respiratory failure due to COVID-19 pneumonia
Sponsor
Ospedale Humanitas Gradenigo
Enrollment
138
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

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)

Registry
who.int
Start Date
June 2, 2021
End Date
September 12, 2021
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Ospedale Humanitas Gradenigo

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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