Corona Virus Infection Clinical Trial
Official title:
Efficacy of Timed Awake Prone and Repositioning in Patients With Covid-19-induced Hypoxic Respiratory Failure: a Multi-center, Randomized Controlled Trial.
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.
Status | Not yet recruiting |
Enrollment | 286 |
Est. completion date | February 18, 2024 |
Est. primary completion date | February 18, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adults = 18 years of age - Awake patients without endotracheal intubation - Suspected or confirmed infection of COVID-19 - Hypoxemia requiring oxygen supplementation = 0.4 FiO2 or = 5L/min via nasal cannula - Bilateral or unilateral chest infiltrates on x-ray or HRCT - Admitted to the ICU or an acute care unit where hemodynamic and respiratory - Willingness to comply with the protocol and provide written informed consent Exclusion Criteria: - Risk of airway obstruction or even asphyxia - Need for emergent intubation after admission - Respiratory failure caused by cardiogenic pulmonary edema - Unable to implement timed prone and repositioning due to any cause - Injury or wound on the ventral body surface affecting the prone position - Unstable fracture of cervical vertebra and spine - Glaucoma or other sharp increases in intraocular pressure - Intracranial hypertension caused by traumatic brain injury etc. - Significantly high risk of pulmonary embolism - Acute hemorrhagic disease - Respiratory rate >40 breaths/min, with significant dyspnea - Transcutaneous oxygen saturation can not be continuously monitored - Hemodynamic 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 help - Difficulty or limitation in autonomous movement, inability to adjust the position without assistance from others - Body mass index > 37 kg/m2 |
Country | Name | City | State |
---|---|---|---|
China | Changxing People's Hospital | Changxing | Zhejiang |
China | The Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang |
China | Lishui Municipal Central Hospital | Lishui | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Second Affiliated Hospital, School of Medicine, Zhejiang University |
China,
Alhazzani W, Parhar KKS, Weatherald J, Al Duhailib Z, Alshahrani M, Al-Fares A, Buabbas S, Cherian SV, Munshi L, Fan E, Al-Hameed F, Chalabi J, Rahmatullah AA, Duan E, Tsang JLY, Lewis K, Lauzier F, Centofanti J, Rochwerg B, Culgin S, Nelson K, Abdukahil SA, Fiest KM, Stelfox HT, Tlayjeh H, Meade MO, Perri D, Solverson K, Niven DJ, Lim R, Moller MH, Belley-Cote E, Thabane L, Tamim H, Cook DJ, Arabi YM; COVI-PRONE Trial Investigators and the Saudi Critical Care Trials Group. Effect of Awake Prone Positioning on Endotracheal Intubation in Patients With COVID-19 and Acute Respiratory Failure: A Randomized Clinical Trial. JAMA. 2022 Jun 7;327(21):2104-2113. doi: 10.1001/jama.2022.7993. — View Citation
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Langer T, Brioni M, Guzzardella A, Carlesso E, Cabrini L, Castelli G, Dalla Corte F, De Robertis E, Favarato M, Forastieri A, Forlini C, Girardis M, Grieco DL, Mirabella L, Noseda V, Previtali P, Protti A, Rona R, Tardini F, Tonetti T, Zannoni F, Antonelli M, Foti G, Ranieri M, Pesenti A, Fumagalli R, Grasselli G; PRONA-COVID Group. Prone position in intubated, mechanically ventilated patients with COVID-19: a multi-centric study of more than 1000 patients. Crit Care. 2021 Apr 6;25(1):128. doi: 10.1186/s13054-021-03552-2. — View Citation
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Tasaka S, Ohshimo S, Takeuchi M, Yasuda H, Ichikado K, Tsushima K, Egi M, Hashimoto S, Shime N, Saito O, Matsumoto S, Nango E, Okada Y, Hayashi K, Sakuraya M, Nakajima M, Okamori S, Miura S, Fukuda T, Ishihara T, Kamo T, Yatabe T, Norisue Y, Aoki Y, Iizuka Y, Kondo Y, Narita C, Kawakami D, Okano H, Takeshita J, Anan K, Okazaki SR, Taito S, Hayashi T, Mayumi T, Terayama T, Kubota Y, Abe Y, Iwasaki Y, Kishihara Y, Kataoka J, Nishimura T, Yonekura H, Ando K, Yoshida T, Masuyama T, Sanui M; ARDS Clinical Practice Guideline 2021 committee from the Japanese Society of Intensive Care Medicine, the Japanese Respiratory Society, and the Japanese Society of Respiratory Care Medicine. ARDS Clinical Practice Guideline 2021. J Intensive Care. 2022 Jul 8;10(1):32. doi: 10.1186/s40560-022-00615-6. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Endotracheal Intubation rate | The incidence of endotracheal Intubation within 30 days of study enrollment | Day 30 | |
Secondary | Mortality | All-cause death within 30 days of study enrollment | Day 30 | |
Secondary | Days of non-invasive ventilation | Number of days alive and free of mechanical ventilation within 30 days of study enrollment | Day 30 | |
Secondary | Days alive and outside the ICU | Number of days alive and outside the ICU within 30 days of study enrollment | Day 30 | |
Secondary | Clinical events | Clinical events include time to treatment failure( treatment failure defined as intubation or death); time to intubation; time to death; duration of invasive mechanical ventilation in intubated patients surviving to day 30; mortality in invasively mechanically ventilated patients; and physiological response to awake prone positioning, including the ratio of SpO2:FiO2 to respiratory rate, known as the ROX index. | Day 30 |
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