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Comparison of noninvasive ventilation by helmet and facial mask in acute respiratory failure : a randomized controlled trial

Comparison of noninvasive ventilation by helmet and facial mask in acute respiratory failure : a randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800017823
Enrollment
Unknown
Registered
2018-08-16
Start date
2018-09-01
Completion date
Unknown
Last updated
2018-08-20

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

Conditions

Acute respiratory failure ,due to acute cardiogenic pulmonary edema, acute exacerbation of chronic obstructive pulmonary disease, chest trauma

Interventions

Group 1:Noninvasive ventilation of helmet
Group 2:Noninvasive ventilation of mask

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. Diagnosis of patient's disease complies with AECOPD, uniform diagnostic criteria for ACPE; (eg AECOPD patients diagnosed according to the guidelines of the global guidelines for prevention and treatment of COPD; heart underlying disease in ACPF patients, respiratory failure caused by ACPE) or patients with a history of trauma and Acute respiratory failure due to trauma or dyspnea requiring assisted ventilation; (eg pulmonary contusion, rib fractures, flail chest or sternal fracture, etc); 2. There is a need for assisted ventilation indicators: (1) moderate to severe dyspnea, manifested as shortness of breath (respiratory rate> 30 beats / min); or use of auxiliary breathing muscles or contracting chest and abdomen; or Pa02 45 mm Hg), or oxygenation index 10L/min) for at least 15min; 3. mediastinal or pericardial no active bleeding, pleural effusion drainage = 100mL/h; 4.Cyclic stability, no high-dose vasoactive drugs (epinephrine <0.05µg/kg/min, dopamine <5µg/kg/min), no serious arrhythmia; 5. urine output = 0.5 mL/kg/h, hemoglobin = 90g/L; 6. Exclusion of contraindications for the use of NIV.

Exclusion criteria

Exclusion criteria: 1. The presence of invasive mechanical ventilation indications, tracheal intubation and invasive ventilator assisted breathing as soon as possible; 2. Deterioration or disturbance of consciousness; 3. Hemodynamic instability (systolic blood pressure <90 mmHg, mean arterial pressure <50 mmHg, electrocardiogram suggestive of myocardial ischemia or severe arrhythmia); 4. Severe cardiac insufficiency (ejection fraction <25%) or cardiopulmonary obstruction; 5. Inhalation of high-risk, oropharyngeal and upper respiratory secretions can not be cleared, respiratory secretions or thick viscous sputum and sputum; 6. A history of malignancy or expected death within a short period of time due to the severity of the underlying disease; 7. Other organ dysfunction (gastrointestinal perforation / hemorrhage or severe cerebrovascular disease); 8. neck or face trauma, burns or upper airway bleeding or obstruction; 9. a large number of pleural effusion who did not drain; 10. Refuse to cooperate or refuse to participate in this study.

Design outcomes

Primary

MeasureTime frame
Arterial oxygen partial pressure;Arterial carbon dioxide partial pressure;PH value;heart rate;respiratory rate;Arterial blood pressure;Tolerance scores;

Secondary

MeasureTime frame
Intensive care unit hospital stay;Non-invasive ventilation time;Hospital mortality;Tracheal intubation rate;Complication rate;

Countries

China

Contacts

Public ContactQiliu

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 4, 2026