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Noninvasive ventilation with helmet compared with facial mask in patients with chest trauma: a randomized controlled study

Noninvasive ventilation with helmet compared with facial mask in patients with chest trauma: a randomized controlled study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900025915
Enrollment
Unknown
Registered
2019-09-14
Start date
2018-09-01
Completion date
Unknown
Last updated
2019-09-16

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

Conditions

Acute Respiratory Failure, Chest Trauma

Interventions

Group 1:NIV with facial mask
Group 2:NIV with helmet

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) Aged older than 18 years; (2) Severe hypoxemic respiratory failure [oxygenation index (PaO2 /FiO2) =10 L/min] mask oxygen. Above two criteria were essential.

Exclusion criteria

Exclusion criteria: 1. impending cardiopulmonary arrest or need for emergency intubation; 2. a Glasgow Coma Scale score lower than 8 score or severe traumatic brain injury; 3. standard contraindications for noninvasive ventilation (active gastrointestinal bleeding, upper airway obstruction or hemodynamic instability); 4. facial trauma with pneumocephalus, skull base fracture, orbit base fracture; 5. facial fracture involving a sinus; 6. cervical injury; 7. elevated intracranial pressure.

Design outcomes

Primary

MeasureTime frame
Oxygenation index;Tolerance of patients;Complications related to NIV;

Secondary

MeasureTime frame
Respiratory rate;Intubation rate;Length of ICU stay;ICU mortality;

Countries

China

Contacts

Public ContactQi Liu

Emergency Intensive Care Ward, the First Affiliated Hospital of Zhengzhou University

qiliu@vip.163.com+86 15981898607

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 24, 2026