COVID-19 Acute Respiratory Distress SyndromeCOVID-19NCT05405335
Effect of Prone Positioning on the Severity of COVID-19 Pneumonia and Acute Respiratory Distress Syndrome.
A study testing Prone Positioning Maneuver in people with COVID-19 Acute Respiratory Distress Syndrome and COVID-19 Pneumonia, run by Ayub Medical College, Abbottabad at 1 site in Pakistan.
Trial summary
With this research, we are aiming at finding out the effectiveness of prone positioning in this region population affected by moderate pneumonia due to covid 19 infection so that the hospital staff and doctors may be encouraged with facts and data to use such an easy maneuver to stabilize patient's oxygen saturation… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19 Acute Respiratory Distress Syndrome, COVID-19 Pneumonia, Prone Positioning
- What is being tested?
- Prone Positioning Maneuver
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Oct 2021to 28 Feb 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Confirmed covid pneumonia/ acute respiratory distress syndrome cases
Who cannot join
- consent denial, patients having contraindications to prone positioning such as shock, acute bleeding, trauma, spinal instability, raised Intracranial Pressure, sternal/ tracheal surgery, Female pregnant patients in 2nd and 3rd trimester
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Prone Positioning on the Severity of COVID-19 Pneumonia and Acute Respiratory Distress Syndrome. A Randomized Clinical Trial
With this research, we are aiming at finding out the effectiveness of prone positioning in this region population affected by moderate pneumonia due to covid 19 infection so that the hospital staff and doctors may be encouraged with facts and data to use such an easy maneuver to stabilize patient's oxygen saturation as we believe that prone positioning does have a protective effect against severe disease and has an effect on reducing mortality if patients are encouraged for prone positioning with proper technique and for suitable time duration as has been observed in the clinical practice in the covid wards. Therefore, we want to assess the effects of 8 hours per day prone positioning the patients with confirmed covid pneumonia admitted in the covid wards.
Read the detailed description
Currently, Pakistan and specifically the Hazara division is being badly hit by the fourth wave of covid 19. Patients are mostly presenting with covid pneumonia with or without other complications such as ARDS, ARF, and shock. A nationwide vaccination drive has been launched in collaboration with the WHO but the general population's response towards getting self-vaccinated is not very much appreciable.
It has been reported in a study from new jersey that awake prone positioning in a spontaneously breathing patients can improve arterial blood oxygen saturation.1 another systematic review of 50 articles, including a total of 2994 patients among which 921 patients were managed with awake prone positioning and the rest by usual care, reported significant improvement in oxygenation parameters with prone positioning. They also concluded that it did not reduce the invasive ventilation rate. 2 another meta-analysis of randomized controlled trials suggested that prone positioning has a protective effect on the lungs by improving oxygenation and can reduce mortality in patients with acute respiratory distress syndrome (ARDS) but also suggested further investigations through randomized clinical trials into the effectiveness of prone positioning in covid 19 associated ARDS. 3
In a report of original investigations, K Solverson et al. concluded that prolonged prone positioning improved oxygenation parameters and reduce mortality but the patients could not tolerate such a long duration. They also suggested a further investigation into the methods to improve the tolerability of awake prone positioning and its long-term benefits.4 Gattinoni L et al. in their multisystem randomized clinical trial where they prone positioned patients for 6 hours per day for a period of 10 days reported that it does improve the oxygenation but it does not improve survival.5 In a randomized controlled trial, Taccone P, reported similar 28th-day and 6th-month outcomes in patients with moderate and severe hypoxemia.6 similar results were reported by Martha A. Q. Curley et al in their study on the pediatric population.7 Guerin C et al. reported no beneficial effects on survival although they did conclude that prone positioning has a protective effect against ventilator-associated pneumonia.8 Ehrmann S et al. in their randomized, controlled, multinational, open-label meta-trial, reported that awake prone positioning of patients with hypoxaemic respiratory failure due to COVID-19 reduces the incidence of treatment failure and the need for intubation without any signal of harm. Their results support the routine use of the prone positioning technique in patients with COVID-19. 9 Binda F et al. in their cross-sectional study on the complications related to prone positioning although considered safe and feasible but reported the prevalence of many complications associated with prone positioning such as pressure ulcers, bleeding from the upper airways, and medical device displacement.10. Malik GR et al. also reported some peripheral nerve injuries especially in the arms after their experience with prone positioning of patients in four tertiary care hospitals.11 None of these complications are immediately fatal and can be managed easily while the patients are in the hospital.
With this research, we are aiming at finding out the effectiveness of prone positioning in this region population affected by moderate pneumonia due to covid 19 infection so that the hospital staff and doctors may be encouraged with facts and data to use such an easy maneuver to stabilize patient's oxygen saturation as we believe that prone positioning does have a protective effect against severe disease and has an effect on reducing mortality if patients are encouraged for prone positioning with proper technique and form suitable time duration as has been observed in the clinical practice in the covid wards. Therefore, we want to assess the effects of 8 hours per day prone positioning the patients with confirmed moderately severe covid pneumonia admitted in the covid wards.
- Being tested
- Prone Positioning Maneuver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone Positioning ManeuverOther
Also called Prone Positioning
intermittent prone positioning for eight hours per day for seven days. each cycle should not be less than 30 minutes or more than 3 hours.
| Study group | Role | What they receive |
|---|---|---|
| Prone Positioned Group | Experimental | Intermittent prone positioning for a total of eight hours per day for seven days. Each cycle of prone positioning should not be less than 30 minutes and note more than 3 hours at one time.
Rest of the treatment as per protocols of the institution Receives: Other: Prone Positioning Maneuver |
| Control Group | No intervention | Treatment as per institutional protocols- the protocols does not involve prone positioning of the patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients dying COVID-19 pneumonia/ ARDS in both groups
Effect of prone positioning on the mortality of patients suffering from covid pneumonia/ acute respiratory distress syndrome
Measured: Three months
Secondary outcomes (1)
Respiratory physiology- mean PaO2 and Mean respiratory rate of both groups at first, seventh and fiourteenth day of admission
effects on the PaO2, respiratory rate and mask type (supplemental oxygen requirement)
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start15 Oct 2021
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19 Acute Respiratory Distress SyndromeStudies 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
- parallel groups randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ayub Medical College, Abbottabad
- Sponsor type
- University, hospital or other
- Collaborators
- Ayub Teaching Hospital
- Responsible party
- Principal investigator, Hamza Javed, Ayub Medical College, Abbottabad
- Investigators
- Hamza Javed, MBBS, Principal investigator, Ayub Teaching Hospital, ABbottabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05405335
- Sponsor's protocol ID
- AyubMC
- Acronym
- COVID-19
- Status last verified
- Jun 2022
- First submitted
- 2 Jun 2022
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Johnson SA, Horton DJ, Fuller MJ, Yee J, Aliyev N, Boltax JP, Chambers JH, Lanspa MJ. Patient-directed Prone Positioning in Awake Patients with COVID-19 Requiring Hospitalization (PAPR). Ann Am Thorac Soc. 2021 Aug;18(8):1424-1426. doi: 10.1513/AnnalsATS.202011-1466RL. No abstract available.
PubMed 33596394Oliveira VM, Weschenfelder ME, Deponti G, Condessa R, Loss SH, Bairros PM, Hochegger T, Daroncho R, Rubin B, Chiste M, Batista DC, Bassegio DM, Nauer Wda S, Piekala DM, Minossi SD, Santos VF, Victorino J, Vieira SR. Good practices for prone positioning at the bedside: Construction of a care protocol. Rev Assoc Med Bras (1992). 2016 May-Jun;62(3):287-93. doi: 10.1590/1806-9282.62.03.287.
PubMed 27310555
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prone Positioning on the Severity of COVID-19 Pneumonia and Acute Respiratory Distress Syndrome. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05405335
- Acronym / sponsor ID
- COVID-19 / AyubMC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Ayub Medical College, AbbottabadUniversity, hospital or other
- Collaborators
- Ayub Teaching Hospital
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 6 Jun 2022 (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.
With this research, we are aiming at finding out the effectiveness of prone positioning in this region population affected by moderate pneumonia due to covid 19 infection so that the hospital staff and doctors may be encouraged with facts and data to use such an easy maneuver to stabilize patient's oxygen saturation as we believe that prone positioning does have a protective effect against severe disease and has an effect on reducing mortality if patients are encouraged for prone positioning with proper technique and for suitable time duration as has been observed in the clinical practice in the covid wards. Therefore, we want to assess the effects of 8 hours per day prone positioning the patients with confirmed covid pneumonia admitted in the covid wards.
Detailed description
Currently, Pakistan and specifically the Hazara division is being badly hit by the fourth wave of covid 19. Patients are mostly presenting with covid pneumonia with or without other complications such as ARDS, ARF, and shock. A nationwide vaccination drive has been launched in collaboration with the WHO but the general population's response towards getting self-vaccinated is not very much appreciable.
It has been reported in a study from new jersey that awake prone positioning in a spontaneously breathing patients can improve arterial blood oxygen saturation.1 another systematic review of 50 articles, including a total of 2994 patients among which 921 patients were managed with awake prone positioning and the rest by usual care, reported significant improvement in oxygenation parameters with prone positioning. They also concluded that it did not reduce the invasive ventilation rate. 2 another meta-analysis of randomized controlled trials suggested that prone positioning has a protective effect on the lungs by improving oxygenation and can reduce mortality in patients with acute respiratory distress syndrome (ARDS) but also suggested further investigations through randomized clinical trials into the effectiveness of prone positioning in covid 19 associated ARDS. 3
In a report of original investigations, K Solverson et al. concluded that prolonged prone positioning improved oxygenation parameters and reduce mortality but the patients could not tolerate such a long duration. They also suggested a further investigation into the methods to improve the tolerability of awake prone positioning and its long-term benefits.4 Gattinoni L et al. in their multisystem randomized clinical trial where they prone positioned patients for 6 hours per day for a period of 10 days reported that it does improve the oxygenation but it does not improve survival.5 In a randomized controlled trial, Taccone P, reported similar 28th-day and 6th-month outcomes in patients with moderate and severe hypoxemia.6 similar results were reported by Martha A. Q. Curley et al in their study on the pediatric population.7 Guerin C et al. reported no beneficial effects on survival although they did conclude that prone positioning has a protective effect against ventilator-associated pneumonia.8 Ehrmann S et al. in their randomized, controlled, multinational, open-label meta-trial, reported that awake prone positioning of patients with hypoxaemic respiratory failure due to COVID-19 reduces the incidence of treatment failure and the need for intubation without any signal of harm. Their results support the routine use of the prone positioning technique in patients with COVID-19. 9 Binda F et al. in their cross-sectional study on the complications related to prone positioning although considered safe and feasible but reported the prevalence of many complications associated with prone positioning such as pressure ulcers, bleeding from the upper airways, and medical device displacement.10. Malik GR et al. also reported some peripheral nerve injuries especially in the arms after their experience with prone positioning of patients in four tertiary care hospitals.11 None of these complications are immediately fatal and can be managed easily while the patients are in the hospital.
With this research, we are aiming at finding out the effectiveness of prone positioning in this region population affected by moderate pneumonia due to covid 19 infection so that the hospital staff and doctors may be encouraged with facts and data to use such an easy maneuver to stabilize patient's oxygen saturation as we believe that prone positioning does have a protective effect against severe disease and has an effect on reducing mortality if patients are encouraged for prone positioning with proper technique and form suitable time duration as has been observed in the clinical practice in the covid wards. Therefore, we want to assess the effects of 8 hours per day prone positioning the patients with confirmed moderately severe covid pneumonia admitted in the covid wards.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- parallel groups randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Prone Positioned Group | Experimental | Other: Prone Positioning ManeuverIntermittent prone positioning for a total of eight hours per day for seven days. Each cycle of prone positioning should not be less than 30 minutes and note more than 3 hours at one time. Rest of the treatment as per protocols of the institution |
| Control Group | No intervention | –Treatment as per institutional protocols- the protocols does not involve prone positioning of the patients |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Confirmed covid pneumonia/ acute respiratory distress syndrome cases
Key exclusion criteria (1 listed)
- consent denial, patients having contraindications to prone positioning such as shock, acute bleeding, trauma, spinal instability, raised Intracranial Pressure, sternal/ tracheal surgery, Female pregnant patients in 2nd and 3rd trimester
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 Positioning ManeuverAlso: Prone Positioningintermittent prone positioning for eight hours per day for seven days. each cycle should not be less than 30 minutes or more than 3 hours. | Other | Prone Positioned Group |
Primary outcome
percentage of patients dying COVID-19 pneumonia/ ARDS in both groups
Time frame: Three months
Effect of prone positioning on the mortality of patients suffering from covid pneumonia/ acute respiratory distress syndrome
1 secondary outcome
Respiratory physiology- mean PaO2 and Mean respiratory rate of both groups at first, seventh and fiourteenth day of admission
Time frame: Three months
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 8 Jun 2022.
- Background: PubMed 33596394Johnson SA, Horton DJ, Fuller MJ, Yee J, Aliyev N, Boltax JP, Chambers JH, Lanspa MJ. Patient-directed Prone Positioning in Awake Patients with COVID-19 Requiring Hospitalization (PAPR). Ann Am Thorac Soc. 2021 Aug;18(8):1424-1426. doi: 10.1513/AnnalsATS.202011-1466RL. No abstract available.
- Background: PubMed 27310555Oliveira VM, Weschenfelder ME, Deponti G, Condessa R, Loss SH, Bairros PM, Hochegger T, Daroncho R, Rubin B, Chiste M, Batista DC, Bassegio DM, Nauer Wda S, Piekala DM, Minossi SD, Santos VF, Victorino J, Vieira SR. Good practices for prone positioning at the bedside: Construction of a care protocol. Rev Assoc Med Bras (1992). 2016 May-Jun;62(3):287-93. doi: 10.1590/1806-9282.62.03.287.
- Individual participant dataSharing planned: No
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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.
Hamza Javed, MBBS principal investigator
Ayub Teaching Hospital, ABbottabad
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 Positioning Maneuver in people with COVID-19 Acute Respiratory Distress Syndrome and COVID-19 Pneumonia, run by Ayub Medical College, Abbottabad at 1 site in Pakistan.
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 1 inclusion and 1 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 8 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 1 site in Pakistan. 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?
percentage of patients dying COVID-19 pneumonia/ ARDS in both groups (time frame: Three months). 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 NCT05405335, which also lists 2 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 8 Jun 2022.