Respiratory Distress SyndromeNCT05719103
Changes in Lung Aeration and Inspiratory Effort With and Without Awake Prone
A study testing With and Without Awake Prone Positioning in people with Respiratory Distress Syndrome and Ventilation Therapy; Complications, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
The investigators aimed to investigate the ventilation homogeneity and transpulmonary pressure during treatments of High-flow nasal cannula(HFNC) and (CPAP) on supine and prone position for COVID-19 or non-COVID-19 patients with acute hypoxemic respiratory failure (AHRF). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Respiratory Distress Syndrome, Ventilation Therapy; Complications
- What is being tested?
- With and Without Awake Prone Positioning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 9 Jan 2023to 31 Dec 2025
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients (18-90 years) who have acute hypoxemic respiratory failure, requiring FIO2 > 0.4 to maintain SpO2 at 90-95% during HFNC at 50 L/min
Who cannot join
- patients who need immediate intubation; refuse to participate in the study; unable to communicate; have contraindication to place the esophageal catheter; unable to use EIT, such as open-chest surgery with chest tube placement; have contraindication for prone positioning, including pregnant, post-abdomen surgery within a week; hypercapnic respiratory failure.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan hospital
Shanghai, 200032
Ming Zhong
About this study
Official title: Changes in Lung Aeration and Inspiratory Effort During High-Flow Nasal Oxygen and Non-Invasive Mechanical Ventilation With and Without Awake Prone
The investigators aimed to investigate the ventilation homogeneity and transpulmonary pressure during treatments of High-flow nasal cannula(HFNC) and (CPAP) on supine and prone position for COVID-19 or non-COVID-19 patients with acute hypoxemic respiratory failure (AHRF).
Read the detailed description
Awake prone positioning (APP) for non-intubated patients has been reported to improve oxygenation for patients with acute hypoxemic respiratory failure (AHRF),particularly for patients with COVID-19 induced AHRF, APP has been shown to decrease the need of intubation.Similarly, APP with helmet continuous positive airway pressure (CPAP) enables a reduction in the work of breathing and an improvement in oxygenation and sensation of dyspnea in COVID-19-associated acute respiratory distress syndrome (ARDS). Moreover, among intubated patients with ARDS assessed by electro-impedance tomography (EIT), prone positioning was found to reduce alveolar overdistention and collapse, resulting in improvement of ventilation homogeneity.However, the effects of APP on the ventilation homogeneity and work of breathing for non-COVID-19 patients with AHRF remain unknown.
High-flow nasal cannula (HFNC) has been proven to improve oxygenation and reduce intubation rate for patients with AHRF in multiple meta-analyses,and has been recommended to treat AHRF in several recently published guidelines.CPAP provides consistent level of positive end-expiratory pressure (PEEP), in comparison to variable level of PEEP generated by HFNC, thus CPAP was reported to have greater improvement of oxygenation than HFNC in 20 patients with AHRF, more importantly, they found that among patients who avoided intubation, the extent of oxygenation improvement was greater with HFNC+APP than with NIV+APP, in contrast, for patients who were intubated, the extent of oxygenation improvement was greater with NIV+APP than with HFNC+APP.This raised the concerns of the self-inflicted lung injury (SILI) generated by heterogenous aeration and large swings of transpulmonary pressure. Thus, the investigators aimed to investigate the ventilation homogeneity and transpulmonary pressure during treatments of HFNC and CPAP on supine and prone.
- Being tested
- With and Without Awake Prone Positioning
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
With and Without Awake Prone PositioningBehavioural
Also called HFNC and NIV
- HFNC flow at 60 L/min or maximum tolerable flow at supine position
- HFNC flow at 60 L/min or maximum tolerable flow at prone position
- CPAP with full face mask at 10 cmH2O at supine position
- CPAP with full face mask at 10 cmH2O at prone position
- MC at supine position
- MC at prone position
| Study group | Role | What they receive |
|---|---|---|
| HFNC SP | Active comparator | HFNC flow at 60 L/min or maximum tolerable flow at supine position Receives: Behavioral: With and Without Awake Prone Positioning |
| HFNC PP | Active comparator | HFNC flow at 60 L/min or maximum tolerable flow at prone position Receives: Behavioral: With and Without Awake Prone Positioning |
| NIV SP | Active comparator | CPAP with full face mask at 10 cmH2O at supine position Receives: Behavioral: With and Without Awake Prone Positioning |
| NIV PP | Active comparator | CPAP with full face mask at 10 cmH2O at prone position Receives: Behavioral: With and Without Awake Prone Positioning |
| MC SP | Placebo comparator | Mask oxygen at supine position Receives: Behavioral: With and Without Awake Prone Positioning |
| MC PP | Placebo comparator | Mask oxygen at prone position Receives: Behavioral: With and Without Awake Prone Positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
The differences in lung homogeneity during HFNC
The differences in lung homogeneity (global inhomogeneity index) during HFNC therapy at 60 L/min or maximum tolerable flow at supine and awake prone position
Measured: 30 minutes
The differences in lung homogeneity during CPAP
The differences in lung homogeneity (global inhomogeneity index) during CPAP with full face mask at 8 cmH2O at supine and awake prone position
Measured: 30 minutes
Secondary outcomes (2)
patient' comfort scores
during HFNC and CPAP treatment at supine and prone position, patient' comfort scores
Measured: 30 minutes
work of breathing
the differences in WOB during HFNC therapy at 60 L/min or maximum tolerable flow at supine and awake prone position
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start9 Jan 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming Zhong, MD, phD, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05719103
- Sponsor's protocol ID
- APP-HF-NIV
- Status last verified
- May 2023
- First submitted
- 16 Jan 2023
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Lung Aeration and Inspiratory Effort During High-Flow Nasal Oxygen and Non-Invasive Mechanical Ventilation With and Without Awake Prone
- ClinicalTrials.gov ID
- NCT05719103
- Acronym / sponsor ID
- APP-HF-NIV
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aimed to investigate the ventilation homogeneity and transpulmonary pressure during treatments of High-flow nasal cannula(HFNC) and (CPAP) on supine and prone position for COVID-19 or non-COVID-19 patients with acute hypoxemic respiratory failure (AHRF).
Detailed description
Awake prone positioning (APP) for non-intubated patients has been reported to improve oxygenation for patients with acute hypoxemic respiratory failure (AHRF),particularly for patients with COVID-19 induced AHRF, APP has been shown to decrease the need of intubation.Similarly, APP with helmet continuous positive airway pressure (CPAP) enables a reduction in the work of breathing and an improvement in oxygenation and sensation of dyspnea in COVID-19-associated acute respiratory distress syndrome (ARDS). Moreover, among intubated patients with ARDS assessed by electro-impedance tomography (EIT), prone positioning was found to reduce alveolar overdistention and collapse, resulting in improvement of ventilation homogeneity.However, the effects of APP on the ventilation homogeneity and work of breathing for non-COVID-19 patients with AHRF remain unknown.
High-flow nasal cannula (HFNC) has been proven to improve oxygenation and reduce intubation rate for patients with AHRF in multiple meta-analyses,and has been recommended to treat AHRF in several recently published guidelines.CPAP provides consistent level of positive end-expiratory pressure (PEEP), in comparison to variable level of PEEP generated by HFNC, thus CPAP was reported to have greater improvement of oxygenation than HFNC in 20 patients with AHRF, more importantly, they found that among patients who avoided intubation, the extent of oxygenation improvement was greater with HFNC+APP than with NIV+APP, in contrast, for patients who were intubated, the extent of oxygenation improvement was greater with NIV+APP than with HFNC+APP.This raised the concerns of the self-inflicted lung injury (SILI) generated by heterogenous aeration and large swings of transpulmonary pressure. Thus, the investigators aimed to investigate the ventilation homogeneity and transpulmonary pressure during treatments of HFNC and CPAP on supine and prone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| HFNC SP | Active comparator | Behavioral: With and Without Awake Prone PositioningHFNC flow at 60 L/min or maximum tolerable flow at supine position |
| HFNC PP | Active comparator | Behavioral: With and Without Awake Prone PositioningHFNC flow at 60 L/min or maximum tolerable flow at prone position |
| NIV SP | Active comparator | Behavioral: With and Without Awake Prone PositioningCPAP with full face mask at 10 cmH2O at supine position |
| NIV PP | Active comparator | Behavioral: With and Without Awake Prone PositioningCPAP with full face mask at 10 cmH2O at prone position |
| MC SP | Placebo comparator | Behavioral: With and Without Awake Prone PositioningMask oxygen at supine position |
| MC PP | Placebo comparator | Behavioral: With and Without Awake Prone PositioningMask oxygen at prone position |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients (18-90 years) who have acute hypoxemic respiratory failure, requiring FIO2 > 0.4 to maintain SpO2 at 90-95% during HFNC at 50 L/min
Key exclusion criteria (1 listed)
- patients who need immediate intubation; refuse to participate in the study; unable to communicate; have contraindication to place the esophageal catheter; unable to use EIT, such as open-chest surgery with chest tube placement; have contraindication for prone positioning, including pregnant, post-abdomen surgery within a week; hypercapnic respiratory failure.
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 |
|---|---|---|
| With and Without Awake Prone PositioningAlso: HFNC and NIV1. HFNC flow at 60 L/min or maximum tolerable flow at supine position 2. HFNC flow at 60 L/min or maximum tolerable flow at prone position 3. CPAP with full face mask at 10 cmH2O at supine position 4. CPAP with full face mask at 10 cmH2O at prone position 5. MC at supine position 6. MC at prone position | Behavioural | HFNC PP, HFNC SP, MC PP, MC SP, NIV PP, NIV SP |
Primary outcome
The differences in lung homogeneity during HFNC
Time frame: 30 minutes
The differences in lung homogeneity (global inhomogeneity index) during HFNC therapy at 60 L/min or maximum tolerable flow at supine and awake prone position
The differences in lung homogeneity during CPAP
Time frame: 30 minutes
The differences in lung homogeneity (global inhomogeneity index) during CPAP with full face mask at 8 cmH2O at supine and awake prone position
2 secondary outcomes
patient' comfort scores
Time frame: 30 minutes
work of breathing
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- 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.
Ming Zhong, MD, phD study chair
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing With and Without Awake Prone Positioning in people with Respiratory Distress Syndrome and Ventilation Therapy; Complications, run by Shanghai Zhongshan Hospital 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 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: status not confirmed, as of the sponsor's last update on 9 May 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming Zhong, MD, phD (021-65642662, zhong.ming@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The differences in lung homogeneity during HFNC (time frame: 30 minutes). 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?
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 9 May 2023.