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Estimate of safety and efficacy of individualized customized non-invasive mechanical ventilation mask for respiratory failure and sleep apnea syndrome

Estimate of safety and efficacy of a positive pressure ventilation mask for the treatment of respiratory failure and sleep apnea based on 3D printing technology

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800016243
Enrollment
Unknown
Registered
2018-05-21
Start date
2018-05-21
Completion date
Unknown
Last updated
2018-05-28

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

Conditions

respiratory failure, sleep apnea syndrome

Interventions

Group 1:Individual Respiratory Masks for Patients with Respiratory Failure
Group 2:Respiratory failure patients use a uniform mask
Group 3:Patients with Sleep Apnea Syndrome Use Individual Respiratory Mask
Group 4:Patients with sleep apnea syndrome use a uniform mask

Sponsors

Wuxi 2nd People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 65 Years

Inclusion criteria

Inclusion criteria: Aged 20-65 years old, after pulmonary function tests, diagnosed as chronic obstructive pulmonary disease, after blood gas analysis, diagnosed as type II respiratory failure, patients in need of home use of ventilator. Standard for patients with sleep apnea syndrome: Age 20-65 years old, diagnosed by polysomnography as sleep apnea-hypopnea syndrome moderate, severe, and untreated patients, all subjects or their guardians must be in Informed consent forms were signed before the trial.

Exclusion criteria

Exclusion criteria: With other basic diseases such as heart disease, poor personal compliance, can not tolerate non-invasive ventilator, positive pressure ventilation mask for exhalation, highly sensitive to the X-ray or should not contact the X-ray.

Design outcomes

Primary

MeasureTime frame
Oxygen saturation;blood gas analysis;

Secondary

MeasureTime frame
comfort;

Countries

China

Contacts

Public ContactWang Xun

Wuxi 2nd People's Hospital

xunwx@163.com+86 18724049616

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026