Prone PositionNCT04760561
Awake Prone Positioning for Non-intubated COVID-19 Patients
A study testing prone position group in people with Prone Position and Coronavirus Disease 2019, run by Damanhour University at 1 site in Egypt.
Trial summary
The burden of coronavirus disease 2019 (COVID-19) pandemic is still on a rising course making a great stress on medical resources throughout the world. Although most of COVID-19 patients require non-invasive oxygenation and ventilation, rapid progression to hypoxemic respiratory failure and then acute respiratory… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Prone Position, Coronavirus Disease 2019, Oxygenation
- What is being tested?
- prone position group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2021to 20 Apr 2021
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-75 years old
- Awake non-intubated spontaneously breathing patients
- Confirmed diagnosis of severe COVID-19; manifesting as dyspnea with respiratory rate ≥ 30 breaths/min, pulse rate ≥ 100 beats/min, oxygen saturation ≤93%, or partial pressure of arterial oxygen (PaO2) to fraction of inspired oxygen (FiO2) ratio ≤ 150 mmHg.
- Positive RT-PCR for SARS-CoV-2 from analysis of nasopharyngeal, oropharyngeal swab, or tracheal secretion specimens and with chest X-ray showing bilateral infiltrations or chest computerized tomographic (CT) images showing exudation or consolidation.
- Requiring supplemental oxygen (nasal cannula, non-invasive CPAP, non-rebreathing face mask)
- Capable of adopting a prone posture independently.
Who cannot join
- The presence of any of the following will mean patients are ineligible:
- life-threatening arrhythmias
- Hemodynamic instability (defined as mean arterial pressure [MAP] < 65mm Hg and use of vasopressors to achieve MAP > 65 mm Hg)
- Altered mental status, intracranial hypertension
- Facial injuries
- Spine or pelvic fractures
Show all 9Show fewer
- Recent abdominal surgery
- Pregnancy
- Altered mental status and patients needing invasive ventilation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Awake Prone Positioning on Oxygenation and Physiological Outcomes in Non-intubated COVID-19 Patients
The burden of coronavirus disease 2019 (COVID-19) pandemic is still on a rising course making a great stress on medical resources throughout the world. Although most of COVID-19 patients require non-invasive oxygenation and ventilation, rapid progression to hypoxemic respiratory failure and then acute respiratory distress syndrome (ARDS) can occur in some COVID19 patients due to prolonged or unaddressed hypoxia. Prone positioning is a common supportive ventilation strategy to improve oxygenation in critically ill patients with ARDS. Recent studies point out the potential benefits of using this strategy for non-intubated awake COVID 19 patients who are hypoxic. Despite several retrospective cohort studies have been conducted to identify impact of the prone positioning in awake non-intubated COVID-19 patients, experimental studies are very rare. This study therefore aims to evaluate the effects of self-prone positioning on oxygenation and physiological outcomes among awake-non intubated patients with COVID-19.
Read the detailed description
A randomised controlled trial design will be adopted to achieve the aim of the current study. In this study 82 adult patients of either sex with a confirmed diagnosis of COVID-19 will be recruited from general intensive care unit of the chest hospital (affiliated to the Ministry of Health) in Damanhour city, El Beheira Governorate, Egypt. Patients will be enrolled in the current study if they meet study inclusion criteria.
The eligible patients will be randomly assigned into two groups (control and intervention group) 41 patients in each. The control group will receive the standard management of COVID-19 patients according to the Egyptian Ministry of health guidelines. The standard management includes supplemental oxygen or non-invasive continuous positive airway pressure (CPAP), antivirals, antibiotics, anticoagulants and glucocorticoids, as necessary, based on the patients' clinical condition. Patients in the control group will be subjected to the conventional positioning interventions provided by the critical care nurses, which will not include self-prone positioning.
Patients in the intervention group will receive self-prone positioning and standard management of COVID-19 patients. All patients in both groups (control and intervention) will be monitored continuously by cardiac monitoring with oxygen saturation (SpO2) during the study period. The demographic and baseline clinical data of all eligible patients will collected and recorded using the study tool.
Each patient in the intervention group will be helped into the prone position and encouraged to stay in the prone position as long as tolerated (at least 1 hour). The prone positioning consists of placing the patient on his or her stomach with the head on the side. Self-prone position will be performed 45 minutes up to 1 hour after meals to avoid gastrointestinal side effects. The patient will be maintained in prone position until the patient becomes too tired and uncomfortable to keep that position. If patients will asked to regain the supine position before the 1 hour period was complete, patient's prone position will be considered unfeasible and the reason will be reported. Patients who required invasive mechanical ventilation at any time point will be intubated and excluded from the study.
The effect of patients' positioning on oxygenation and physiological parameters will be collected and recorded. These parameters include vital signs (respiratory rate, systolic blood pressure, diastolic blood pressure and heart rate), SpO2, oxygenation index (PaO2/FiO2 ratio), ROX index (combination of the ratio of oxygen saturation measured by pulse oximetry to fraction of inspired oxygen and respiratory rate [SpO2/FiO2]/respiratory rate) and arterial blood gases parameters (pH, PaO2mmHg, PaCO2mmHg and SaO2). These parameters will be recorded before and after positioning (immediately before, after 10 minutes and after 1hour). Data of secondary outcomes of self-prone positioning will also be collected and recorded.
- Conditions
- Prone Position, Coronavirus Disease 2019, Oxygenation
- Being tested
- prone position group
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prone position groupProcedure or surgery
Patients randomized to this arm will receive self-prone positioning. Each patient in the intervention group will be helped into the prone position and encouraged to stay in the prone position as long as tolerated (at least 1 hour). The prone positioning consists of placing the patient on his or her stomach with the head on the side. Self-prone position will be performed 45 minutes up to 1 hour after meals to avoid gastrointestinal side effects. The patient will be maintained in prone position until the patient becomes too tired and uncomfortable to keep that position. If patients will asked to regain the supine position before the 1 hour period was complete, patient's prone position will be considered unfeasible and the reason will be reported. Patients who required invasive mechanical ventilation at any time point will be intubated and excluded from the study.
| Study group | Role | What they receive |
|---|---|---|
| Control group (conventional care) | No intervention | Patients randomized to this arm will receive the conventional positioning interventions provided by the critical care nurses, which will not include self-prone positioning. |
| Intervention group (prone position group) | Experimental | Patients randomized to this arm will receive self-prone positioning. Receives: Procedure: prone position group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation index
arterial oxygen pressure/fractional inspired oxygen PaO2/FiO2 ratio mmHg.
Measured: Change in the value immediately before, after 10 minutes and after 1hour of patient positioning
SpO2
Peripheral oxygen saturation
Measured: Change in the value immediately before, after 10 minutes and after 1hour of patient positioning.
ROX index
combination of the ratio of oxygen saturation measured by pulse oximetry to fraction of inspired ox¬ygen and respiratory rate ([SpO2/FiO2]/respiratory rate)
Measured: Change in the value immediately before and after 1hour of patient positioning.
PaO2mmHg
Partial pressure of oxygen within arterial blood
Measured: change in the value immediately before and after 1hour of patient positioning.
PCO2mmHg
The partial pressure of carbon dioxide within arterial blood
Measured: change in the value immediately before and after 1hour of patient positioning.
SaO2
Oxygen saturation (SaO2) is a measurement of the percentage of how much hemoglobin is saturated with oxygen.
Measured: change in the value immediately before and after 1hour of patient positioning.
pH
The acidity or alkalinity of blood.
Measured: change in the value immediately before and after 1hour of patient positioning.
Respiratory Rate (RR) (bpm)
the number of breaths a person takes per minute.
Measured: change in the value immediately before, after 10 minutes and after 1hour of patient positioning.
Heart Rate (HR) (bpm)
is the the speed of the heartbeat measured by the number of contractions (beats) of the heart per minute (bpm)
Measured: change in the value immediately before, after 10 minutes and after 1hour of patient positioning.
Blood Pressure (BP) mmHg
is the the pressure of circulating blood against the walls of blood vessels.
Measured: change in the value immediately before, after 10 minutes and after 1hour of patient positioning.
Positive response to prone positioning
defined as a 10% increase in PaO2/FiO2 ratio or 10% decrease in respiratory rate
Measured: Time Frame: change in the value of PaO2/FiO2 ratio or respiratory rate after 1hour of patient positioning
Secondary outcomes (1)
Prone position adverse events
respiratory distress, dyspnea, use of accessory respiratory muscles, oxygen desaturation SpO2≤70%, hypotension SBP≤90 mmHg, vomiting, aspiration, musculoskeletal pain, discomfort, facial edema, pressure ulcers and accidental withdrawal of catheters, tubes and/or drainages.
Measured: appearance of events from 10 minutes after patient positioning up to 3hours after patient positioning..
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start20 Feb 2021
- Primary completion20 Mar 2021
- Study completion20 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Prone PositionStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental research design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damanhour University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sahar Younes, Damanhour University
- Investigators
- Sahar Y Othman, A/P., Principal investigator, Faculty of Nursing, Damanhour UniversityAlaa M Mohamed, Lect., Study director, Faculty of Nursing, Damanhour UniversityAhmed M El-Menshawy, Lect., Study director, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04760561
- Sponsor's protocol ID
- Proning for COVID-19 Patients
- Status last verified
- Jan 2022
- First submitted
- 15 Feb 2021
- Last updated
- 4 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Binda F, Marelli F, Galazzi A, Pascuzzo R, Adamini I, Laquintana D. Nursing Management of Prone Positioning in Patients With COVID-19. Crit Care Nurse. 2021 Apr 1;41(2):27-35. doi: 10.4037/ccn2020222.
PubMed 33341885Dubosh NM, Wong ML, Grossestreuer AV, Loo YK, Sanchez LD, Chiu D, Leventhal EL, Ilg A, Donnino MW. Early, awake proning in emergency department patients with COVID-19. Am J Emerg Med. 2021 Aug;46:640-645. doi: 10.1016/j.ajem.2020.11.074. Epub 2020 Dec 3.
PubMed 33309507Flynn Makic MB. Prone Position of Patients With COVID-19 and Acute Respiratory Distress Syndrome. J Perianesth Nurs. 2020 Aug;35(4):437-438. doi: 10.1016/j.jopan.2020.05.008. Epub 2020 May 30. No abstract available.
PubMed 32741521Solverson K, Weatherald J, Parhar KKS. Tolerability and safety of awake prone positioning COVID-19 patients with severe hypoxemic respiratory failure. Can J Anaesth. 2021 Jan;68(1):64-70. doi: 10.1007/s12630-020-01787-1. Epub 2020 Aug 14.
PubMed 32803468Sztajnbok J, Maselli-Schoueri JH, Cunha de Resende Brasil LM, Farias de Sousa L, Cordeiro CM, Sansao Borges LM, Malaque CMSA. Prone positioning to improve oxygenation and relieve respiratory symptoms in awake, spontaneously breathing non-intubated patients with COVID-19 pneumonia. Respir Med Case Rep. 2020;30:101096. doi: 10.1016/j.rmcr.2020.101096. Epub 2020 May 19.
PubMed 32455107Cotton S, Zawaydeh Q, LeBlanc S, Husain A, Malhotra A. Proning during covid-19: Challenges and solutions. Heart Lung. 2020 Nov-Dec;49(6):686-687. doi: 10.1016/j.hrtlng.2020.08.006. Epub 2020 Aug 19.
PubMed 32861885
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Awake Prone Positioning on Oxygenation and Physiological Outcomes in Non-intubated COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04760561
- Acronym / sponsor ID
- Proning for COVID-19 Patients
- Conditions
- Prone Position, Coronavirus Disease 2019, Oxygenation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Damanhour UniversityUniversity, hospital or other
- Study start
- 20 Feb 2021 (actual)
- Primary completion
- 20 Mar 2021 (actual)
- Study completion
- 20 Apr 2021 (actual)
- First posted
- 18 Feb 2021 (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.
The burden of coronavirus disease 2019 (COVID-19) pandemic is still on a rising course making a great stress on medical resources throughout the world. Although most of COVID-19 patients require non-invasive oxygenation and ventilation, rapid progression to hypoxemic respiratory failure and then acute respiratory distress syndrome (ARDS) can occur in some COVID19 patients due to prolonged or unaddressed hypoxia. Prone positioning is a common supportive ventilation strategy to improve oxygenation in critically ill patients with ARDS. Recent studies point out the potential benefits of using this strategy for non-intubated awake COVID 19 patients who are hypoxic. Despite several retrospective cohort studies have been conducted to identify impact of the prone positioning in awake non-intubated COVID-19 patients, experimental studies are very rare. This study therefore aims to evaluate the effects of self-prone positioning on oxygenation and physiological outcomes among awake-non intubated patients with COVID-19.
Detailed description
A randomised controlled trial design will be adopted to achieve the aim of the current study. In this study 82 adult patients of either sex with a confirmed diagnosis of COVID-19 will be recruited from general intensive care unit of the chest hospital (affiliated to the Ministry of Health) in Damanhour city, El Beheira Governorate, Egypt. Patients will be enrolled in the current study if they meet study inclusion criteria.
The eligible patients will be randomly assigned into two groups (control and intervention group) 41 patients in each. The control group will receive the standard management of COVID-19 patients according to the Egyptian Ministry of health guidelines. The standard management includes supplemental oxygen or non-invasive continuous positive airway pressure (CPAP), antivirals, antibiotics, anticoagulants and glucocorticoids, as necessary, based on the patients' clinical condition. Patients in the control group will be subjected to the conventional positioning interventions provided by the critical care nurses, which will not include self-prone positioning.
Patients in the intervention group will receive self-prone positioning and standard management of COVID-19 patients. All patients in both groups (control and intervention) will be monitored continuously by cardiac monitoring with oxygen saturation (SpO2) during the study period. The demographic and baseline clinical data of all eligible patients will collected and recorded using the study tool.
Each patient in the intervention group will be helped into the prone position and encouraged to stay in the prone position as long as tolerated (at least 1 hour). The prone positioning consists of placing the patient on his or her stomach with the head on the side. Self-prone position will be performed 45 minutes up to 1 hour after meals to avoid gastrointestinal side effects. The patient will be maintained in prone position until the patient becomes too tired and uncomfortable to keep that position. If patients will asked to regain the supine position before the 1 hour period was complete, patient's prone position will be considered unfeasible and the reason will be reported. Patients who required invasive mechanical ventilation at any time point will be intubated and excluded from the study.
The effect of patients' positioning on oxygenation and physiological parameters will be collected and recorded. These parameters include vital signs (respiratory rate, systolic blood pressure, diastolic blood pressure and heart rate), SpO2, oxygenation index (PaO2/FiO2 ratio), ROX index (combination of the ratio of oxygen saturation measured by pulse oximetry to fraction of inspired oxygen and respiratory rate [SpO2/FiO2]/respiratory rate) and arterial blood gases parameters (pH, PaO2mmHg, PaCO2mmHg and SaO2). These parameters will be recorded before and after positioning (immediately before, after 10 minutes and after 1hour). Data of secondary outcomes of self-prone positioning will also be collected and recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental research design
| Arm | Type | Receives |
|---|---|---|
| Control group (conventional care) | No intervention | –Patients randomized to this arm will receive the conventional positioning interventions provided by the critical care nurses, which will not include self-prone positioning. |
| Intervention group (prone position group) | Experimental | Procedure: prone position groupPatients randomized to this arm will receive self-prone positioning. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18-75 years old
- Awake non-intubated spontaneously breathing patients
- Confirmed diagnosis of severe COVID-19; manifesting as dyspnea with respiratory rate ≥ 30 breaths/min, pulse rate ≥ 100 beats/min, oxygen saturation ≤93%, or partial pressure of arterial oxygen (PaO2) to fraction of inspired oxygen (FiO2) ratio ≤ 150 mmHg.
- Positive RT-PCR for SARS-CoV-2 from analysis of nasopharyngeal, oropharyngeal swab, or tracheal secretion specimens and with chest X-ray showing bilateral infiltrations or chest computerized tomographic (CT) images showing exudation or consolidation.
- Requiring supplemental oxygen (nasal cannula, non-invasive CPAP, non-rebreathing face mask)
Key exclusion criteria (9 listed)
- life-threatening arrhythmias
- Hemodynamic instability (defined as mean arterial pressure [MAP] < 65mm Hg and use of vasopressors to achieve MAP > 65 mm Hg)
- Altered mental status, intracranial hypertension
- Facial injuries
- Spine or pelvic fractures
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 |
|---|---|---|
| prone position groupPatients randomized to this arm will receive self-prone positioning. Each patient in the intervention group will be helped into the prone position and encouraged to stay in the prone position as long as tolerated (at least 1 hour). The prone positioning consists of placing the patient on his or her stomach with the head on the side. Self-prone position will be performed 45 minutes up to 1 hour after meals to avoid gastrointestinal side effects. The patient will be maintained in prone position until the patient becomes too tired and uncomfortable to keep that position. If patients will asked to regain the supine position before the 1 hour period was complete, patient's prone position will be considered unfeasible and the reason will be reported. Patients who required invasive mechanical ventilation at any time point will be intubated and excluded from the study. | Procedure or surgery | Intervention group (prone position group) |
Primary outcome
Oxygenation index
Time frame: Change in the value immediately before, after 10 minutes and after 1hour of patient positioning
arterial oxygen pressure/fractional inspired oxygen PaO2/FiO2 ratio mmHg.
SpO2
Time frame: Change in the value immediately before, after 10 minutes and after 1hour of patient positioning.
Peripheral oxygen saturation
ROX index
Time frame: Change in the value immediately before and after 1hour of patient positioning.
combination of the ratio of oxygen saturation measured by pulse oximetry to fraction of inspired ox¬ygen and respiratory rate ([SpO2/FiO2]/respiratory rate)
PaO2mmHg
Time frame: change in the value immediately before and after 1hour of patient positioning.
Partial pressure of oxygen within arterial blood
PCO2mmHg
Time frame: change in the value immediately before and after 1hour of patient positioning.
The partial pressure of carbon dioxide within arterial blood
SaO2
Time frame: change in the value immediately before and after 1hour of patient positioning.
Oxygen saturation (SaO2) is a measurement of the percentage of how much hemoglobin is saturated with oxygen.
pH
Time frame: change in the value immediately before and after 1hour of patient positioning.
The acidity or alkalinity of blood.
Respiratory Rate (RR) (bpm)
Time frame: change in the value immediately before, after 10 minutes and after 1hour of patient positioning.
the number of breaths a person takes per minute.
Heart Rate (HR) (bpm)
Time frame: change in the value immediately before, after 10 minutes and after 1hour of patient positioning.
is the the speed of the heartbeat measured by the number of contractions (beats) of the heart per minute (bpm)
Blood Pressure (BP) mmHg
Time frame: change in the value immediately before, after 10 minutes and after 1hour of patient positioning.
is the the pressure of circulating blood against the walls of blood vessels.
Positive response to prone positioning
Time frame: Time Frame: change in the value of PaO2/FiO2 ratio or respiratory rate after 1hour of patient positioning
defined as a 10% increase in PaO2/FiO2 ratio or 10% decrease in respiratory rate
1 secondary outcome
Prone position adverse events
Time frame: appearance of events from 10 minutes after patient positioning up to 3hours after patient positioning..
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
- Background: PubMed 33341885Binda F, Marelli F, Galazzi A, Pascuzzo R, Adamini I, Laquintana D. Nursing Management of Prone Positioning in Patients With COVID-19. Crit Care Nurse. 2021 Apr 1;41(2):27-35. doi: 10.4037/ccn2020222.
- Background: PubMed 33309507Dubosh NM, Wong ML, Grossestreuer AV, Loo YK, Sanchez LD, Chiu D, Leventhal EL, Ilg A, Donnino MW. Early, awake proning in emergency department patients with COVID-19. Am J Emerg Med. 2021 Aug;46:640-645. doi: 10.1016/j.ajem.2020.11.074. Epub 2020 Dec 3.
- Background: PubMed 32741521Flynn Makic MB. Prone Position of Patients With COVID-19 and Acute Respiratory Distress Syndrome. J Perianesth Nurs. 2020 Aug;35(4):437-438. doi: 10.1016/j.jopan.2020.05.008. Epub 2020 May 30. No abstract available.
- Background: PubMed 32803468Solverson K, Weatherald J, Parhar KKS. Tolerability and safety of awake prone positioning COVID-19 patients with severe hypoxemic respiratory failure. Can J Anaesth. 2021 Jan;68(1):64-70. doi: 10.1007/s12630-020-01787-1. Epub 2020 Aug 14.
- Background: PubMed 32455107Sztajnbok J, Maselli-Schoueri JH, Cunha de Resende Brasil LM, Farias de Sousa L, Cordeiro CM, Sansao Borges LM, Malaque CMSA. Prone positioning to improve oxygenation and relieve respiratory symptoms in awake, spontaneously breathing non-intubated patients with COVID-19 pneumonia. Respir Med Case Rep. 2020;30:101096. doi: 10.1016/j.rmcr.2020.101096. Epub 2020 May 19.
- Background: PubMed 32861885Cotton S, Zawaydeh Q, LeBlanc S, Husain A, Malhotra A. Proning during covid-19: Challenges and solutions. Heart Lung. 2020 Nov-Dec;49(6):686-687. doi: 10.1016/j.hrtlng.2020.08.006. Epub 2020 Aug 19.
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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.
Sahar Y Othman, A/P. principal investigator
Faculty of Nursing, Damanhour University
Alaa M Mohamed, Lect. study director
Faculty of Nursing, Damanhour University
Ahmed M El-Menshawy, Lect. study director
University of Alexandria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prone position group in people with Prone Position and Coronavirus Disease 2019, run by Damanhour University at 1 site in Egypt.
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 6 inclusion and 9 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: finished, as of the sponsor's last update on 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Oxygenation index (time frame: Change in the value immediately before, after 10 minutes and after 1hour of patient positioning). The study lists 11 primary outcomes in all. 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 NCT04760561, which also lists 6 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 4 Feb 2022.