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

NCT05689216 | Unknown

• 1 other identifier: 2023-0027
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Corona Virus Infection; Hypoxic Respiratory Failure

Keywords

Awake prone positioning

Outcome Measures

Primary Outcomes (1)

• Endotracheal Intubation rate

  The incidence of endotracheal Intubation within 30 days of study enrollment

  Day 30

Secondary Outcomes (4)

• Mortality

  Day 30

• Days of non-invasive ventilation

  Day 30

• Days alive and outside the ICU

  Day 30

• Clinical events

  Day 30

Study Arms (2)

Awake timed prone and repositioning group

EXPERIMENTAL

Patients' cumulative prone and repositioning time is encouraged to reach 8-10 hours per day for 4 days following a timed prone and repositioning strategy.

Behavioral: Awake timed prone and repositioning

Standard care group

NO INTERVENTION

Patients can change their positions freely according to their own needs. Health providers do not take the initiative to give guidance on prone and repositioning.

Interventions

Awake timed prone and repositioning BEHAVIORAL

Patients were instructed to adopt a timed prone and repositioning strategy with 4 sessions for four consecutive days. Session 1, lying on the belly; Session 2, lying on the right side; Session 3, sitting up; Session 4, lying on the left side; then back to session 1 (30 minutes to two hours for each session). The daily duration of timed prone and repositioning is strongly recommended for 8-10 hours.

Awake timed prone and repositioning group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (3)

Changxing People's Hospital

Changxing, Zhejiang, 313199, China

Location

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

Lishui Municipal Central Hospital

Lishui, Zhejiang, 323020, China

Location

Related Publications (10)

• Fralick M, Colacci M, Munshi L, Venus K, Fidler L, Hussein H, Britto K, Fowler R, da Costa BR, Dhalla I, Dunbar-Yaffe R, Branfield Day L, MacMillan TE, Zipursky J, Carpenter T, Tang T, Cooke A, Hensel R, Bregger M, Gordon A, Worndl E, Go S, Mandelzweig K, Castellucci LA, Tamming D, Razak F, Verma AA; COVID Prone Study Investigators. Prone positioning of patients with moderate hypoxaemia due to covid-19: multicentre pragmatic randomised trial (COVID-PRONE). BMJ. 2022 Mar 23;376:e068585. doi: 10.1136/bmj-2021-068585.

  PMID: 35321918 BACKGROUND

• Sun Q, Qiu H, Huang M, Yang Y. Lower mortality of COVID-19 by early recognition and intervention: experience from Jiangsu Province. Ann Intensive Care. 2020 Mar 18;10(1):33. doi: 10.1186/s13613-020-00650-2. No abstract available.

  PMID: 32189136 BACKGROUND

• Wright AD, Flynn M. Using the prone position for ventilated patients with respiratory failure: a review. Nurs Crit Care. 2011 Jan-Feb;16(1):19-27. doi: 10.1111/j.1478-5153.2010.00425.x.

  PMID: 21199551 BACKGROUND

• Murray TA, Patterson LA. Prone positioning of trauma patients with acute respiratory distress syndrome and open abdominal incisions. Crit Care Nurse. 2002 Jun;22(3):52-6. No abstract available.

  PMID: 12092293 BACKGROUND

• 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.

  PMID: 33823862 BACKGROUND

• 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.

  PMID: 35799288 BACKGROUND

• Serpa Neto A, Checkley W, Sivakorn C, Hashmi M, Papali A, Schultz MJ; COVID-LMIC Task Force and the Mahidol-Oxford Research Unit (MORU). Pragmatic Recommendations for the Management of Acute Respiratory Failure and Mechanical Ventilation in Patients with COVID-19 in Low- and Middle-Income Countries. Am J Trop Med Hyg. 2021 Jan 13;104(3_Suppl):60-71. doi: 10.4269/ajtmh.20-0796.

  PMID: 33534774 BACKGROUND

• Ehrmann S, Li J, Ibarra-Estrada M, Perez Y, Pavlov I, McNicholas B, Roca O, Mirza S, Vines D, Garcia-Salcido R, Aguirre-Avalos G, Trump MW, Nay MA, Dellamonica J, Nseir S, Mogri I, Cosgrave D, Jayaraman D, Masclans JR, Laffey JG, Tavernier E; Awake Prone Positioning Meta-Trial Group. Awake prone positioning for COVID-19 acute hypoxaemic respiratory failure: a randomised, controlled, multinational, open-label meta-trial. Lancet Respir Med. 2021 Dec;9(12):1387-1395. doi: 10.1016/S2213-2600(21)00356-8. Epub 2021 Aug 20.

  PMID: 34425070 BACKGROUND

• 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.

  PMID: 35569448 BACKGROUND

• Li J, Luo J, Pavlov I, Perez Y, Tan W, Roca O, Tavernier E, Kharat A, McNicholas B, Ibarra-Estrada M, Vines DL, Bosch NA, Rampon G, Simpson SQ, Walkey AJ, Fralick M, Verma A, Razak F, Harris T, Laffey JG, Guerin C, Ehrmann S; Awake Prone Positioning Meta-Analysis Group. Awake prone positioning for non-intubated patients with COVID-19-related acute hypoxaemic respiratory failure: a systematic review and meta-analysis. Lancet Respir Med. 2022 Jun;10(6):573-583. doi: 10.1016/S2213-2600(22)00043-1. Epub 2022 Mar 16.

  PMID: 35305308 BACKGROUND

Related Links

• https://emcrit.org/wp-content/uploads/2020/04/2020-04-12-Guidance-for-conscious-proning.pdf

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Min Yan, M.D.

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY CHAIR

Central Study Contacts

Yuanyuan Yao, M.D.

CONTACT

+86-18058783258; yuanyuan58@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Department of Anesthesia and Surgery

Study Record Dates

• First Submitted: January 14, 2023
• First Posted: January 19, 2023
• Study Start: January 18, 2023
• Primary Completion: February 18, 2024
• Study Completion: February 18, 2024
• Last Updated: January 19, 2023

Record last verified: 2023-01

Locations

CN (3)