Investigating lung aeration and breathing effort with and without awake prone positioning
Changes in Lung Aeration and Inspiratory Effort During High-Flow Nasal Oxygen and Non-Invasive Mechanical Ventilation With and Without Awake Prone
NA · Shanghai Zhongshan Hospital · NCT05719103
This study is testing if lying face down while awake can help adults with breathing problems get better oxygen and breathe easier, comparing different oxygen treatments in that position.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Shanghai Zhongshan Hospital (other) |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT05719103 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effects of awake prone positioning (APP) on lung aeration and inspiratory effort in patients with acute hypoxemic respiratory failure (AHRF), both COVID-19 and non-COVID-19 related. It compares the use of high-flow nasal cannula (HFNC) and continuous positive airway pressure (CPAP) in supine and prone positions. The research will assess ventilation homogeneity and transpulmonary pressure to determine the benefits of APP in improving oxygenation and reducing the need for intubation. The study will include adult patients who require supplemental oxygen to maintain adequate blood oxygen levels.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-90 with acute hypoxemic respiratory failure requiring high levels of supplemental oxygen.
Not a fit: Patients who need immediate intubation or have contraindications to prone positioning will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with acute hypoxemic respiratory failure, potentially reducing the need for intubation.
How similar studies have performed: Previous studies have shown success with awake prone positioning in improving outcomes for patients with COVID-19 related respiratory distress, but its effects on non-COVID-19 patients remain largely unexplored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Where this trial is running
Shanghai
- Zhongshan hospital — Shanghai, China (RECRUITING)
Study contacts
- Study coordinator: Ming Zhong, MD, phD
- Email: zhong.ming@zs-hospital.sh.cn
- Phone: 021-65642662
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Respiratory Distress Syndrome, Ventilation Therapy, Complications