Covid19NCT04754113
Effect of Prone Position onV/Q Matching in Non-intubated Patients With COVID-19
A study testing prone position in people with Covid19, run by Southeast University, China at 1 site in China.
Trial summary
A prospective physiologic study, in participants with COVID-19-related pneumonia requiring supplemental oxygen (standard oxygen therapy or high-flow nasal cannula (HFNC)) less than 24 hours. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Covid19
- What is being tested?
- prone position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteChina
- Study dates
- 8 Feb 2021to 15 Jan 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18 to75 years
- admitted to intensive care unit with a confirmed diagnosis of COVID-19-related pneumonia
- requiring supplemental oxygen (standard oxygen therapy or high-flow nasal cannula (HFNC)) less than 24 hours,
- gave written or witnessed verbal informed consent.
Who cannot join
- uncollaborative or had an altered mental status,
- New York Heart Association class above II
- history of severe chronic obstructive pulmonary disease
- Contraindications to the use of EIT (e.g., presence of pacemaker or chest surgical wounds dressing) or prone position (as decided by the attending physician)
- Impending intubation (on the basis of clinical judgment, including clinical and physiological parameters).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Prone Position on Lung Ventilation and Perfusion Matching in Non-intubated Patients With COVID-19 Pneumonia
A prospective physiologic study, in participants with COVID-19-related pneumonia requiring supplemental oxygen (standard oxygen therapy or high-flow nasal cannula (HFNC)) less than 24 hours. The investigators assessed the effect of prone position on ventilation inhomogeneity and ventilation/perfusion mismatch by electrical impedance tomography (EIT).
Read the detailed description
Once enrolled, an EIT dedicated belt containing 16 electrodes was placed around the participant's chest at the fifth or sixth intercostal space and connected it to an EIT monitor (PulmoVista 500; Dräger Medical GmbH, Lübeck, Germany).
Baseline data were collected during supine position (timepoint SP1), including demographic and anthropometric data, a baseline arterial blood gas measurement, and ventilation parameters including type of supplemental oxygen, respiratory rate, fractional concentration of oxygen in inspired air (FiO2). The participants received instructions of end expiratory occlusion lasting at least 10 seconds and, 1 seconds after the start, a bolus of 10 mL of 5% NaCl solution was injected via the central venous catheter. Subsequently, each participant was helped into the prone position and data collection，end expiratory occlusion and 10% NaCl solution injection were preformed again after approximately 30 min (timepoint PP1). The participant was then encouraged to maintain the prone position for at least 3 h before being helped back into the supine position. Clinical data collection, end expiratory occlusion and injection of a bolus of 10 mL of 5% NaCl solution were repeated again 1 h after resupination (timepoint SP2).
- Conditions
- Covid19
- Being tested
- prone position
- Keywords
- COVID-19, prone position, ventilation and perfusion matching
- Medical subject headings
- COVID-19, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prone positionOther
patient was helped into the prone position, patient received instructions of end expiratory occlusion lasting at least 10 seconds and, 1 seconds after the start, a bolus of 10 mL of 5% NaCl solution was injected via the central venous catheter
| Study group | Role | What they receive |
|---|---|---|
| prone position | Experimental | patients from supine to prone for at least 3 hours than re-supine Receives: Other: prone position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilation-perfusion (V/Q) mismatch
V/Q mismatch was quantified as the percentage of pixels that were classified as ventilated but not perfused (dead space fraction) plus the percentage of those perfused but not ventilated (shunt fraction).
Measured: prone position 1 hour
Ventilation-perfusion (V/Q) mismatch
V/Q mismatch was quantified as the percentage of pixels that were classified as ventilated but not perfused (dead space fraction) plus the percentage of those perfused but not ventilated (shunt fraction).
Measured: resupination 1 hour
Secondary outcomes (4)
Regional ventilation
The percentage of relative pixel-level ventilation (Vpixel) distending dorsal lung regions at each study phase
Measured: Baseline，prone position 1hour, resupination 1 hour
regional perfusion
The pixel-level relative regional pulmonary perfusion
Measured: Baseline，prone position 1hour, resupination 1 hour
The Global Inhomogeneity (GI) index
higher values indicating less homogenous ventilation
Measured: Baseline，prone position 1hour, resupination 1 hour
PF raio
PaO2/FiO2
Measured: Baseline，prone position 1hour, resupination 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start8 Feb 2021
- Primary completion1 Jan 2022
- Study completion15 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Liu, Southeast University, China
- Investigators
- Ling Liu, Study director, Zhongda Hospital, School of Medicinr, Southeast Univerty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04754113
- Sponsor's protocol ID
- COVID-19 PPV
- Status last verified
- Jan 2022
- First submitted
- 6 Feb 2021
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chao Y, Yuan X, Zhao Z, Frerichs I, Li Z, Sun Q, Chen D, Zhang R, Qiu H, Liu L. Physiologic effects of prone positioning on gas exchange and ventilation-perfusion matching in awake patients with AHRF. BMC Pulm Med. 2024 Dec 4;24(1):600. doi: 10.1186/s12890-024-03411-0.
PubMed 39663512
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prone Position on Lung Ventilation and Perfusion Matching in Non-intubated Patients With COVID-19 Pneumonia
- ClinicalTrials.gov ID
- NCT04754113
- Acronym / sponsor ID
- COVID-19 PPV
- Conditions
- Covid19
- Keywords
- COVID-19, prone position, ventilation and perfusion matching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 15 Jan 2022 (actual)
- First posted
- 15 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.
A prospective physiologic study, in participants with COVID-19-related pneumonia requiring supplemental oxygen (standard oxygen therapy or high-flow nasal cannula (HFNC)) less than 24 hours. The investigators assessed the effect of prone position on ventilation inhomogeneity and ventilation/perfusion mismatch by electrical impedance tomography (EIT).
Detailed description
Once enrolled, an EIT dedicated belt containing 16 electrodes was placed around the participant's chest at the fifth or sixth intercostal space and connected it to an EIT monitor (PulmoVista 500; Dräger Medical GmbH, Lübeck, Germany).
Baseline data were collected during supine position (timepoint SP1), including demographic and anthropometric data, a baseline arterial blood gas measurement, and ventilation parameters including type of supplemental oxygen, respiratory rate, fractional concentration of oxygen in inspired air (FiO2). The participants received instructions of end expiratory occlusion lasting at least 10 seconds and, 1 seconds after the start, a bolus of 10 mL of 5% NaCl solution was injected via the central venous catheter. Subsequently, each participant was helped into the prone position and data collection，end expiratory occlusion and 10% NaCl solution injection were preformed again after approximately 30 min (timepoint PP1). The participant was then encouraged to maintain the prone position for at least 3 h before being helped back into the supine position. Clinical data collection, end expiratory occlusion and injection of a bolus of 10 mL of 5% NaCl solution were repeated again 1 h after resupination (timepoint SP2).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| prone position | Experimental | Other: prone positionpatients from supine to prone for at least 3 hours than re-supine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged 18 to75 years
- admitted to intensive care unit with a confirmed diagnosis of COVID-19-related pneumonia
- requiring supplemental oxygen (standard oxygen therapy or high-flow nasal cannula (HFNC)) less than 24 hours,
- gave written or witnessed verbal informed consent.
Key exclusion criteria (5 listed)
- uncollaborative or had an altered mental status,
- New York Heart Association class above II
- history of severe chronic obstructive pulmonary disease
- Contraindications to the use of EIT (e.g., presence of pacemaker or chest surgical wounds dressing) or prone position (as decided by the attending physician)
- Impending intubation (on the basis of clinical judgment, including clinical and physiological parameters).
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 positionpatient was helped into the prone position, patient received instructions of end expiratory occlusion lasting at least 10 seconds and, 1 seconds after the start, a bolus of 10 mL of 5% NaCl solution was injected via the central venous catheter | Other | prone position |
Primary outcome
Ventilation-perfusion (V/Q) mismatch
Time frame: prone position 1 hour
V/Q mismatch was quantified as the percentage of pixels that were classified as ventilated but not perfused (dead space fraction) plus the percentage of those perfused but not ventilated (shunt fraction).
Ventilation-perfusion (V/Q) mismatch
Time frame: resupination 1 hour
V/Q mismatch was quantified as the percentage of pixels that were classified as ventilated but not perfused (dead space fraction) plus the percentage of those perfused but not ventilated (shunt fraction).
4 secondary outcomes
Regional ventilation
Time frame: Baseline，prone position 1hour, resupination 1 hour
regional perfusion
Time frame: Baseline，prone position 1hour, resupination 1 hour
The Global Inhomogeneity (GI) index
Time frame: Baseline，prone position 1hour, resupination 1 hour
PF raio
Time frame: Baseline，prone position 1hour, resupination 1 hour
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 25 Jan 2022.
- Derived from this study: PubMed 39663512Chao Y, Yuan X, Zhao Z, Frerichs I, Li Z, Sun Q, Chen D, Zhang R, Qiu H, Liu L. Physiologic effects of prone positioning on gas exchange and ventilation-perfusion matching in awake patients with AHRF. BMC Pulm Med. 2024 Dec 4;24(1):600. doi: 10.1186/s12890-024-03411-0.
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Ling Liu study director
Zhongda Hospital, School of Medicinr, Southeast Univerty
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 in people with Covid19, run by Southeast University, China at 1 site 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 4 inclusion and 5 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 25 Jan 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 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?
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?
Ventilation-perfusion (V/Q) mismatch (time frame: prone position 1 hour). The study lists 2 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 NCT04754113, which also lists 1 linked publication.
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 25 Jan 2022.