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Prone positioning in non-intubated patients with acute respiratory failure monitoring with electrical impedance tomography

Prone positioning in non-intubated patients with acute respiratory failure monitoring with electrical impedance tomography: A prospective,single center, parallel-group randomized controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035895
Enrollment
Unknown
Registered
2020-08-19
Start date
2020-10-01
Completion date
Unknown
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute respiratory failure

Interventions

Group 1:Prone Positioning in patients with HFNC
Group 2:HFNC

Sponsors

Shanghai General Hospital, Shanghai Jiao Tong University, School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years old, male or female; 2. Meet the diagnostic criteria of ARF (ARDS), and the diagnosis of ARF shall not exceed 48 hours until the enrollment: 1) The disease occurs within one week after the known cause or the onset of new or aggravating respiratory symptoms; 2) Reduced transmittance of both lungs, and could not be completely explained by pleural effusion, atelectasis or tuberosity; 3) Respiratory failure that cannot be explained by cardiac failure or fluid overload, and if there are no risk factors, an objective assessment (e.g., cardiac ultrasonography) is required to exclude pulmonary edema due to increased hydrostatic pressure; 4) PaO2/FiO2=5 cmH2O; 3. Admitted to the intensive care unit or equipped with bedside respiratory circulation monitoring facilities; 4. Informed consent.

Exclusion criteria

Exclusion criteria: 1. Respiratory muscle fatigue (RR > 40/min and PaCO2 > 60mmHg/pH =0.5 ug/kg*min); 3. Decreased level of consciousness, Glasgow coma Scale (GCS) 35 kg/m^2; 7. Contraindications to prone position: 1) Open thoracic and abdominal wounds and large wounds; 2) Abdominal surgery within 4 days; 3) Intra-abdominal high pressure; 4) Facial, pelvic and spinal fractures or instability; 5) Chest trauma, untreated pneumothorax; 6) Skeletal deformities affecting prone position, such as severe posterior scoliosis and severe limb contracture; 7) Fatal arrhythmia. 8. Other conditions in the treatment group that immediate endotracheal intubation and invasive mechanical ventilation are required; 9. Pregnant or breast-feeding patients.

Design outcomes

Primary

MeasureTime frame
Intubation rate in 28 days;

Secondary

MeasureTime frame
All-cause mortality in 28 days;

Countries

China

Contacts

Public ContactWang Ruilan

Shanghai General Hospital, Shanghai Jiao Tong University, School of Medicine

wangyusun@hotmail.com+86 13917138008

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026