Corona Virus InfectionNCT05689216
Timed Awake Prone and Repositioning for Patients With Covid-19-induced Hypoxic Respiratory Failure.
A study testing Awake timed prone and repositioning in people with Corona Virus Infection and Hypoxic Respiratory Failure, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corona Virus Infection, Hypoxic Respiratory Failure
- What is being tested?
- Awake timed prone and repositioning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 3 sitesChina
- Study dates
- 18 Jan 2023to 18 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
China3 sites
Changxing People's Hospital
Changxing, Zhejiang, 313199
jingfen Jin, +86-13757118239
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Min Yan, Doctor, zryanmin@zju.edu.cn
Lishui Municipal Central Hospital
Lishui, Zhejiang, 323020
Meifen Chen, Doctor, +86-13567618608
About this study
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.
Read the detailed description
Patients with COVID-19 may develop severe illness characterized by progressive hypoxic respiratory failure, resulting in the need for invasive mechanical ventilation. Reducing the rate of endotracheal intubation in patients with hypoxic respiratory failure can be beneficial to the prognosis, economize iatrical resources and reduce sanitary investment. Some studies have shown that prone positioning can improve oxygenation to some extent in patients receiving invasive mechanical ventilation due to severe ARDS.
Whether awake prone positioning can reduce endotracheal intubation and mortality in COVID-19 patients with hypoxic respiratory failure is still controversial. A meta-analysis found that the awake prone positioning was safe and feasible to reduce the risk of intubation or death. However, the multicenter randomized controlled trial (RCT) conducted by Alhazzani et al pointed out that the awake prone positioning group did not significantly reduce the rate of endotracheal intubation when compared with the standard of care.
Some researchers thought the time of prone positioning is an important factor for the different results. In previous studies, the median duration of prone positioning was only 4.8-5 hours per day but some guidelines recommend the duration should be more than 8 hours. Therefore, increasing patient adherence in the awake prone positioning and extending prone positioning time are of great importance.
Awake timed prone and repositioning is a novel method proposed in recent years, which can improve patients' compliance and prolong the time of treatment. This study intends to ask whether awake timed prone and repositioning could impact the intubation rate and prognosis of unincubated patients with hypoxic respiratory failure induced by COVID-19.
- Being tested
- Awake timed prone and repositioning
- Keywords
- Awake prone positioning
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Awake timed prone and repositioningBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endotracheal Intubation rate
The incidence of endotracheal Intubation within 30 days of study enrollment
Measured: Day 30
Secondary outcomes (4)
Mortality
All-cause death within 30 days of study enrollment
Measured: Day 30
Days of non-invasive ventilation
Number of days alive and free of mechanical ventilation within 30 days of study enrollment
Measured: Day 30
Days alive and outside the ICU
Number of days alive and outside the ICU within 30 days of study enrollment
Measured: Day 30
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.
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start18 Jan 2023 (estimated)
- Primary completion18 Feb 2024 (estimated)
- Study completion18 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Corona Virus InfectionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 286 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Yan, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Investigators
- Min Yan, M.D., Study chair, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689216
- Sponsor's protocol ID
- 2023-0027
- Status last verified
- Jan 2023
- First submitted
- 14 Jan 2023
- Last updated
- 19 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35321918Sun 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.
PubMed 32189136Wright 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.
PubMed 21199551Murray 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.
PubMed 12092293Langer 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.
PubMed 33823862Tasaka 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.
PubMed 35799288Serpa 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.
PubMed 33534774Ehrmann 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.
PubMed 34425070Alhazzani 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.
PubMed 35569448Li 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.
PubMed 35305308
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Timed Awake Prone and Repositioning in Patients With Covid-19-induced Hypoxic Respiratory Failure: a Multi-center, Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05689216
- Acronym / sponsor ID
- 2023-0027
- Keywords
- Awake prone positioning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 18 Jan 2023 (estimated)
- Primary completion
- 18 Feb 2024 (estimated)
- Study completion
- 18 Feb 2024 (estimated)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients with COVID-19 may develop severe illness characterized by progressive hypoxic respiratory failure, resulting in the need for invasive mechanical ventilation. Reducing the rate of endotracheal intubation in patients with hypoxic respiratory failure can be beneficial to the prognosis, economize iatrical resources and reduce sanitary investment. Some studies have shown that prone positioning can improve oxygenation to some extent in patients receiving invasive mechanical ventilation due to severe ARDS.
Whether awake prone positioning can reduce endotracheal intubation and mortality in COVID-19 patients with hypoxic respiratory failure is still controversial. A meta-analysis found that the awake prone positioning was safe and feasible to reduce the risk of intubation or death. However, the multicenter randomized controlled trial (RCT) conducted by Alhazzani et al pointed out that the awake prone positioning group did not significantly reduce the rate of endotracheal intubation when compared with the standard of care.
Some researchers thought the time of prone positioning is an important factor for the different results. In previous studies, the median duration of prone positioning was only 4.8-5 hours per day but some guidelines recommend the duration should be more than 8 hours. Therefore, increasing patient adherence in the awake prone positioning and extending prone positioning time are of great importance.
Awake timed prone and repositioning is a novel method proposed in recent years, which can improve patients' compliance and prolong the time of treatment. This study intends to ask whether awake timed prone and repositioning could impact the intubation rate and prognosis of unincubated patients with hypoxic respiratory failure induced by COVID-19.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Awake timed prone and repositioning group | Experimental | Behavioral: Awake timed prone and repositioningPatients' cumulative prone and repositioning time is encouraged to reach 8-10 hours per day for 4 days following a timed prone and repositioning strategy. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Awake timed prone and repositioningPatients 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. | Behavioural | Awake timed prone and repositioning group |
Primary outcome
Endotracheal Intubation rate
Time frame: Day 30
The incidence of endotracheal Intubation within 30 days of study enrollment
4 secondary outcomes
Mortality
Time frame: Day 30
Days of non-invasive ventilation
Time frame: Day 30
Days alive and outside the ICU
Time frame: Day 30
Clinical events
Time frame: Day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Background: PubMed 35321918Fralick 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.
- Background: PubMed 32189136Sun 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.
- Background: PubMed 21199551Wright 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.
- Background: PubMed 12092293Murray 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.
- Background: PubMed 33823862Langer 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.
- Background: PubMed 35799288Tasaka 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.
- Background: PubMed 33534774Serpa 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.
- Background: PubMed 34425070Ehrmann 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.
- Background: PubMed 35569448Alhazzani 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.
- Background: PubMed 35305308Li 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.
- https://emcrit.org/wp-content/uploads/2020/04/2020-04-12-Guidance-for-conscious-proning.pdfLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Yan, M.D. study chair
Second Affiliated Hospital, Zhejiang University, School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Awake timed prone and repositioning in people with Corona Virus Infection and Hypoxic Respiratory Failure, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuanyuan Yao, M.D. (+86-18058783258, yuanyuan58@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endotracheal Intubation rate (time frame: Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05689216, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2023.