COVIDUPSATNCT04344561
Incline Positioning in COVID-19 Patients for Improvement in Oxygen Saturation
A study testing Postural Positioning in people with COVID and Hypoxic Respiratory Failure, run by Johns Hopkins University at 2 sites in United States.
Trial summary
COVID-19 is a respiratory illness caused by SARS-CoV-2 with a range of symptoms from mild, self-limiting respiratory tract infections to severe progressive pneumonia, multiorgan dysfunction and death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID, Hypoxic Respiratory Failure
- What is being tested?
- Postural Positioning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 May 2020to 1 May 2022
- 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
- COVID-19 positive
- Pneumonia defined as hospitalization for acute (< 7 days) onset of symptoms (cough, sputum production, or dyspnea).
- Hypoxemia defined as ≥ 2 L/min oxygen
Who cannot join
- Intubation
- Inability to lie supine
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Bayview Hospital
Baltimore, Maryland, 21224
Johns Hopkins Hospital
Baltimore, Maryland, 21287
About this study
Official title: UPright Incline Positioning in COVID-19 Patients for Oxygen SATuration Improvement With Hypoxemic Respiratory Failure (UPSAT)
COVID-19 is a respiratory illness caused by SARS-CoV-2 with a range of symptoms from mild, self-limiting respiratory tract infections to severe progressive pneumonia, multiorgan dysfunction and death. A portion of individuals with COVID-19 experience life-threatening hypoxia requiring supplemental oxygen and mechanical ventilation. Management of hypoxia in this population is complicated by contraindication of non-invasive ventilation and limitations in access to mechanical ventilation and critical care staff given the clinical burden of disease. Positional therapy is readily deployable and may ultimately be used to treat COVID-19 related respiratory failure in resources limited settings; and, it has been demonstrated to improve oxygenation and is easy to implement in the clinical setting.
The overall goal of this randomized controlled trial is to establish the feasibility of performing a randomized trial using a simple, minimally invasive positional therapy approach to improve hypoxia and reduce progression to mechanical ventilation. The objectives are to examine the effectiveness and feasibility of maintaining an inclined position in patients with confirmed or suspected COVID-19 associated hypoxemic respiratory failure. The investigators hypothesize that (1) oxyhemoglobin saturation will improve with therapy, (2) participants will tolerate and adhere to the intervention, and that (3) participants who adhere to positional therapy will have reduced rates of mechanical ventilation at 72 hours. If successful, this feasibility trial will demonstrate that a simple, readily deployed nocturnal postural maneuver is well tolerated and reverses underlying defects in ventilation and oxygenation due to COVID-19. It will also inform the design of a pivotal Phase III trial with estimates of sample sizes for clinically relevant outcomes.
Read the detailed description
Study Design: The investigators will conduct a pilot study to examine the acute effects of inclined posture on oxyhemoglobin saturation and the feasibility of conducting randomized controlled clinical trial among patients with confirmed or suspected COVID-19-associated hypoxia.
In a subgroup of participants, the investigators will examine the acute effect of postural therapy (15-degree incline on hospital beds) on oxyhemoglobin saturation among hypoxic patients to establish a biologic response. The investigators will enroll a subset of participants (n=16) who will lie supine on hospital beds, which will be placed in the horizontal (flat) or 15-degree inclined (reverse Trendelenberg) orientation in random order. During this time, the investigators will continuous record pulse oximetry, pulse rate and variations in peripheral arterial tone with WatchPAT one devices. Subjects will be visually monitored for work of breathing during this time. If work of breathing becomes excessive, as defined as a sustain respiratory rate of >25 and an increase of >5 breaths per minute from baseline, or oxygenation decreases below 88% for > 30 seconds in the inclined position, then maneuvers will be stopped. If the patient meets these criteria in the flat position, then the investigators sit the patient upright, and allow breathing to return to baseline before examining responses in the inclined position.
The investigators will randomize participants to have beds placed in 15-degree incline or usual care (ad-lib positioning) for 72 hours. During the first night in a subgroup of participants, the investigators will record oxygenation, sleep wake state and markers of sympathetic activity with WatchPAT One devices, which can obtain cardiopulmonary parameters with high temporal resolution. The investigators will obtain vital signs from the data warehouse, which archives telemetry data with a maximum sampling frequency of 1 minute. The investigators will record adherence with continuous accelerometry sensors placed on the bed rails and on the anterolateral surface of participants' chests to measure bed and participants' positions, respectively. Aside from position, participants will receive usual treatment for COVID-19.
The investigators will enroll in 3 phases. At the end of each phase, the investigators will assess for completion of milestones for proceeding to the subsequent phase, as detailed below:
- Pilot Study: The investigators will pilot the study in 16 participants to obtain critical information on logistics of conducting the trial including performance of recording instruments in a biocontainment environment, to examine the feasibility of the intervention, perform preliminary safety evaluations to ascertain potential harm and to determine whether the intervention results in a meaningful difference in body position.
- Phase II RCT: If inclined therapy results in a difference in body position and no significant safety issues were detected, the investigators will conduct a phase II randomized-controlled trial (RCT) in 70 participants (see sample size calculation below) to estimate the effect size of inclined position on rates of intubation and determine sample size for a Phase III trial.
Randomization will be occur in both phases and will be stratified by study phase and study site.
- Conditions
- COVID, Hypoxic Respiratory Failure
- Being tested
- Postural Positioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postural PositioningOther
Investigators will adjust the positioning of hospital beds to assess improvements in oxygenation and respiratory status.
| Study group | Role | What they receive |
|---|---|---|
| Postural Positioning | Experimental | Participants in the group will have hospital beds placed in 15 degree (reverse Trendelenburg). Receives: Other: Postural Positioning |
| Standard Care | No intervention | Participants in this group will have beds managed per standard nursing protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Mechanical Ventilation
Number of participants needing mechanical ventilation over total number of participants per arm.
Measured: 72 hours
Secondary outcomes (6)
Number of participants with supplemental oxygen requirements
Number of participants with supplemental oxygen requirements.
Measured: 72 hours
Mean oxyhemoglobin saturation
Mean oxyhemoglobin saturation (percentage) measured over a 24-hour period.
Measured: At 24, 48 and 72 hours
Mean Nocturnal Oxyhemoglobin Saturation
Mean oxyhemoglobin saturation (percentage) measured over an 8-hour period (between 10pm and 6am).
Measured: Measured between 10pm and 6am daily, up to 72 hours
Heart Rate
Heart Rate (beats per minute) on Routine Vital Sign Assessment.
Measured: At 10, 24, 48 and 72 hours
Respiratory Rate
Respiratory Rate (cycles per minute) on Routine Vital Sign Assessment.
Measured: At 10, 24, 48 and 72 hours
Percentage of time in the assigned position
Percentage of time participants stay in the assigned position will be used to determine adherence.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start25 May 2020
- Primary completion1 May 2022
- Study completion1 May 2022
Why it stopped: Inability to recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luu Pham, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344561
- Sponsor's protocol ID
- IRB00246834
- Acronym
- UPSAT
- Status last verified
- Jun 2022
- First submitted
- 10 Apr 2020
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Access to IPD on reasonable request
Publications
Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
PubMed 32007143Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
PubMed 31986264Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.
PubMed 32031570Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
PubMed 32109013Scholten EL, Beitler JR, Prisk GK, Malhotra A. Treatment of ARDS With Prone Positioning. Chest. 2017 Jan;151(1):215-224. doi: 10.1016/j.chest.2016.06.032. Epub 2016 Jul 8.
PubMed 27400909Scaravilli V, Grasselli G, Castagna L, Zanella A, Isgro S, Lucchini A, Patroniti N, Bellani G, Pesenti A. Prone positioning improves oxygenation in spontaneously breathing nonintubated patients with hypoxemic acute respiratory failure: A retrospective study. J Crit Care. 2015 Dec;30(6):1390-4. doi: 10.1016/j.jcrc.2015.07.008. Epub 2015 Jul 16.
PubMed 26271685Ikeda H, Ayuse T, Oi K. The effects of head and body positioning on upper airway collapsibility in normal subjects who received midazolam sedation. J Clin Anesth. 2006 May;18(3):185-93. doi: 10.1016/j.jclinane.2005.08.010.
PubMed 16731320Penzel T, Moller M, Becker HF, Knaack L, Peter JH. Effect of sleep position and sleep stage on the collapsibility of the upper airways in patients with sleep apnea. Sleep. 2001 Feb 1;24(1):90-5. doi: 10.1093/sleep/24.1.90.
PubMed 11204057Oksenberg A, Silverberg DS. The effect of body posture on sleep-related breathing disorders: facts and therapeutic implications. Sleep Med Rev. 1998 Aug;2(3):139-62. doi: 10.1016/s1087-0792(98)90018-1.
PubMed 15310498Neill AM, Angus SM, Sajkov D, McEvoy RD. Effects of sleep posture on upper airway stability in patients with obstructive sleep apnea. Am J Respir Crit Care Med. 1997 Jan;155(1):199-204. doi: 10.1164/ajrccm.155.1.9001312.
PubMed 9001312Oksenberg A, Khamaysi I, Silverberg DS, Tarasiuk A. Association of body position with severity of apneic events in patients with severe nonpositional obstructive sleep apnea. Chest. 2000 Oct;118(4):1018-24. doi: 10.1378/chest.118.4.1018.
PubMed 11035672Hakala K, Maasilta P, Sovijarvi AR. Upright body position and weight loss improve respiratory mechanics and daytime oxygenation in obese patients with obstructive sleep apnoea. Clin Physiol. 2000 Jan;20(1):50-5. doi: 10.1046/j.1365-2281.2000.00223.x.
PubMed 10651792Guerin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.
PubMed 23688302Boudewyns A, Punjabi N, Van de Heyning PH, De Backer WA, O'Donnell CP, Schneider H, Smith PL, Schwartz AR. Abbreviated method for assessing upper airway function in obstructive sleep apnea. Chest. 2000 Oct;118(4):1031-41. doi: 10.1378/chest.118.4.1031.
PubMed 11035674Meng L, Qiu H, Wan L, Ai Y, Xue Z, Guo Q, Deshpande R, Zhang L, Meng J, Tong C, Liu H, Xiong L. Intubation and Ventilation amid the COVID-19 Outbreak: Wuhan's Experience. Anesthesiology. 2020 Jun;132(6):1317-1332. doi: 10.1097/ALN.0000000000003296.
PubMed 32195705
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UPright Incline Positioning in COVID-19 Patients for Oxygen SATuration Improvement With Hypoxemic Respiratory Failure (UPSAT)
- ClinicalTrials.gov ID
- NCT04344561
- Acronym / sponsor ID
- UPSAT / IRB00246834
- Conditions
- COVID, Hypoxic Respiratory Failure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to recruit
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 25 May 2020 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 14 Apr 2020 (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.
COVID-19 is a respiratory illness caused by SARS-CoV-2 with a range of symptoms from mild, self-limiting respiratory tract infections to severe progressive pneumonia, multiorgan dysfunction and death. A portion of individuals with COVID-19 experience life-threatening hypoxia requiring supplemental oxygen and mechanical ventilation. Management of hypoxia in this population is complicated by contraindication of non-invasive ventilation and limitations in access to mechanical ventilation and critical care staff given the clinical burden of disease. Positional therapy is readily deployable and may ultimately be used to treat COVID-19 related respiratory failure in resources limited settings; and, it has been demonstrated to improve oxygenation and is easy to implement in the clinical setting.
The overall goal of this randomized controlled trial is to establish the feasibility of performing a randomized trial using a simple, minimally invasive positional therapy approach to improve hypoxia and reduce progression to mechanical ventilation. The objectives are to examine the effectiveness and feasibility of maintaining an inclined position in patients with confirmed or suspected COVID-19 associated hypoxemic respiratory failure. The investigators hypothesize that (1) oxyhemoglobin saturation will improve with therapy, (2) participants will tolerate and adhere to the intervention, and that (3) participants who adhere to positional therapy will have reduced rates of mechanical ventilation at 72 hours. If successful, this feasibility trial will demonstrate that a simple, readily deployed nocturnal postural maneuver is well tolerated and reverses underlying defects in ventilation and oxygenation due to COVID-19. It will also inform the design of a pivotal Phase III trial with estimates of sample sizes for clinically relevant outcomes.
Detailed description
Study Design: The investigators will conduct a pilot study to examine the acute effects of inclined posture on oxyhemoglobin saturation and the feasibility of conducting randomized controlled clinical trial among patients with confirmed or suspected COVID-19-associated hypoxia.
In a subgroup of participants, the investigators will examine the acute effect of postural therapy (15-degree incline on hospital beds) on oxyhemoglobin saturation among hypoxic patients to establish a biologic response. The investigators will enroll a subset of participants (n=16) who will lie supine on hospital beds, which will be placed in the horizontal (flat) or 15-degree inclined (reverse Trendelenberg) orientation in random order. During this time, the investigators will continuous record pulse oximetry, pulse rate and variations in peripheral arterial tone with WatchPAT one devices. Subjects will be visually monitored for work of breathing during this time. If work of breathing becomes excessive, as defined as a sustain respiratory rate of >25 and an increase of >5 breaths per minute from baseline, or oxygenation decreases below 88% for > 30 seconds in the inclined position, then maneuvers will be stopped. If the patient meets these criteria in the flat position, then the investigators sit the patient upright, and allow breathing to return to baseline before examining responses in the inclined position.
The investigators will randomize participants to have beds placed in 15-degree incline or usual care (ad-lib positioning) for 72 hours. During the first night in a subgroup of participants, the investigators will record oxygenation, sleep wake state and markers of sympathetic activity with WatchPAT One devices, which can obtain cardiopulmonary parameters with high temporal resolution. The investigators will obtain vital signs from the data warehouse, which archives telemetry data with a maximum sampling frequency of 1 minute. The investigators will record adherence with continuous accelerometry sensors placed on the bed rails and on the anterolateral surface of participants' chests to measure bed and participants' positions, respectively. Aside from position, participants will receive usual treatment for COVID-19.
The investigators will enroll in 3 phases. At the end of each phase, the investigators will assess for completion of milestones for proceeding to the subsequent phase, as detailed below:
- Pilot Study: The investigators will pilot the study in 16 participants to obtain critical information on logistics of conducting the trial including performance of recording instruments in a biocontainment environment, to examine the feasibility of the intervention, perform preliminary safety evaluations to ascertain potential harm and to determine whether the intervention results in a meaningful difference in body position.
- Phase II RCT: If inclined therapy results in a difference in body position and no significant safety issues were detected, the investigators will conduct a phase II randomized-controlled trial (RCT) in 70 participants (see sample size calculation below) to estimate the effect size of inclined position on rates of intubation and determine sample size for a Phase III trial.
Randomization will be occur in both phases and will be stratified by study phase and study site.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postural Positioning | Experimental | Other: Postural PositioningParticipants in the group will have hospital beds placed in 15 degree (reverse Trendelenburg). |
| Standard Care | No intervention | –Participants in this group will have beds managed per standard nursing protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- COVID-19 positive
- Pneumonia defined as hospitalization for acute (< 7 days) onset of symptoms (cough, sputum production, or dyspnea).
- Hypoxemia defined as ≥ 2 L/min oxygen
Key exclusion criteria (2 listed)
- Intubation
- Inability to lie supine
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 |
|---|---|---|
| Postural PositioningInvestigators will adjust the positioning of hospital beds to assess improvements in oxygenation and respiratory status. | Other | Postural Positioning |
Primary outcome
Incidence of Mechanical Ventilation
Time frame: 72 hours
Number of participants needing mechanical ventilation over total number of participants per arm.
6 secondary outcomes
Number of participants with supplemental oxygen requirements
Time frame: 72 hours
Mean oxyhemoglobin saturation
Time frame: At 24, 48 and 72 hours
Mean Nocturnal Oxyhemoglobin Saturation
Time frame: Measured between 10pm and 6am daily, up to 72 hours
Heart Rate
Time frame: At 10, 24, 48 and 72 hours
Respiratory Rate
Time frame: At 10, 24, 48 and 72 hours
Percentage of time in the assigned position
Time frame: 72 hours
Results and safety
The study was stopped early (reason given: Inability to recruit). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
- Background: PubMed 32007143Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
- Background: PubMed 31986264Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
- Background: PubMed 32031570Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.
- Background: PubMed 32109013Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
- Background: PubMed 27400909Scholten EL, Beitler JR, Prisk GK, Malhotra A. Treatment of ARDS With Prone Positioning. Chest. 2017 Jan;151(1):215-224. doi: 10.1016/j.chest.2016.06.032. Epub 2016 Jul 8.
- Background: PubMed 26271685Scaravilli V, Grasselli G, Castagna L, Zanella A, Isgro S, Lucchini A, Patroniti N, Bellani G, Pesenti A. Prone positioning improves oxygenation in spontaneously breathing nonintubated patients with hypoxemic acute respiratory failure: A retrospective study. J Crit Care. 2015 Dec;30(6):1390-4. doi: 10.1016/j.jcrc.2015.07.008. Epub 2015 Jul 16.
- Background: PubMed 16731320Ikeda H, Ayuse T, Oi K. The effects of head and body positioning on upper airway collapsibility in normal subjects who received midazolam sedation. J Clin Anesth. 2006 May;18(3):185-93. doi: 10.1016/j.jclinane.2005.08.010.
- Background: PubMed 11204057Penzel T, Moller M, Becker HF, Knaack L, Peter JH. Effect of sleep position and sleep stage on the collapsibility of the upper airways in patients with sleep apnea. Sleep. 2001 Feb 1;24(1):90-5. doi: 10.1093/sleep/24.1.90.
- Background: PubMed 15310498Oksenberg A, Silverberg DS. The effect of body posture on sleep-related breathing disorders: facts and therapeutic implications. Sleep Med Rev. 1998 Aug;2(3):139-62. doi: 10.1016/s1087-0792(98)90018-1.
- Background: PubMed 9001312Neill AM, Angus SM, Sajkov D, McEvoy RD. Effects of sleep posture on upper airway stability in patients with obstructive sleep apnea. Am J Respir Crit Care Med. 1997 Jan;155(1):199-204. doi: 10.1164/ajrccm.155.1.9001312.
- Background: PubMed 11035672Oksenberg A, Khamaysi I, Silverberg DS, Tarasiuk A. Association of body position with severity of apneic events in patients with severe nonpositional obstructive sleep apnea. Chest. 2000 Oct;118(4):1018-24. doi: 10.1378/chest.118.4.1018.
- Background: PubMed 10651792Hakala K, Maasilta P, Sovijarvi AR. Upright body position and weight loss improve respiratory mechanics and daytime oxygenation in obese patients with obstructive sleep apnoea. Clin Physiol. 2000 Jan;20(1):50-5. doi: 10.1046/j.1365-2281.2000.00223.x.
- Individual participant dataSharing planned: No. Access to IPD on reasonable request
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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.
Luu Pham, MD principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postural Positioning in people with COVID and Hypoxic Respiratory Failure, run by Johns Hopkins University at 2 sites in United States.
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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The study was stopped early (reason given: Inability to recruit). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Mechanical Ventilation (time frame: 72 hours). 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 NCT04344561, which also lists 15 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 6 Jun 2022.