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Not Yet Recruiting NCT05689216

Timed Awake Prone and Repositioning for Patients With Covid-19-induced Hypoxic Respiratory Failure.

Conditions: Corona Virus Infection, Hypoxic Respiratory Failure

Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 286
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Location: China

Summary

Awake prone positioning has been reported to improve oxygenation for patients with COVID-19. Awake timed and repositioning is a novel method to improve patients' compliance and prolong the prone time. This study aims to explore the impact of timed prone and repositioning on the intubation rate and prognosis of COVID-19 patients with hypoxic respiratory failure.

Eligibility Criteria

Inclusion Criteria:Adults ≥ 18 years of ageAwake patients without endotracheal intubationSuspected or confirmed infection of COVID-19Hypoxemia requiring oxygen supplementation ≥ 0.4 FiO2 or ≥ 5L/min via nasal cannulaBilateral or unilateral chest infiltrates on x-ray or HRCTAdmitted to the ICU or an acute care unit where hemodynamic and respiratoryWillingness to comply with the protocol and provide written informed consentExclusion Criteria:Risk of airway obstruction or even asphyxiaNeed for emergent intubation after admissionRespiratory failure caused by cardiogenic pulmonary edemaUnable to implement timed prone and repositioning due to any causeInjury or wound on the ventral body surface affecting the prone positionUnstable fracture of cervical vertebra and spineGlaucoma or other sharp increases in intraocular pressureIntracranial hypertension caused by traumatic brain injury etc.Significantly high risk of pulmonary embolismAcute hemorrhagic diseaseRespiratory rate >40 breaths/min, with significant dyspneaTranscutaneous oxygen saturation can not be continuously monitoredHemodynamic instability requiring vasoactive drugs (systolic blood pressure <90 mmHg or mean arterial pressure <65 mmHg despite adequate volume resuscitation)Awareness disorder or inability to accept instructions, communication barrier with the nursing team, inability to use language or pager to call for helpDifficulty or limitation in autonomous movement, inability to adjust the position without assistance from othersBody mass index > 37 kg/m2

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05689216). StuddyBuddy aggregates publicly available trial information.