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Effect of Helmet Continuous positive airway pressure vs noninvasive nasal mask in Patients With COPD: A Randomized Controlled Pilot Trial

Effect of Helmet Continuous positive airway pressure vs noninvasive nasal mask in Patients With Chronic Obstructive Pulmonary Disease: A Randomized Controlled Pilot Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062394
Enrollment
Unknown
Registered
2022-08-04
Start date
2022-08-05
Completion date
Unknown
Last updated
2023-04-12

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

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

helmet CPAP:helmet CPAP
noninvasive nasal mask:noninvasive nasal mask

Sponsors

The First Affiliated Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1)Adults >= 18 years old; 2)Diagnosed with COPD; 3)patients with an indication for partial-assisted ventilaton; 4)Intact airway system; 5)Subjects were conscious with spontaneous breathing; 6)Subjects voluntarily participated in this trial, signed the informed consent, and complied with the follow-up process.

Exclusion criteria

Exclusion criteria: 1)Preexisting Cardiac arrest/cardiopulmonary resuscitation history/Severe cardiac dysfunction (Ejection fraction <25%)/pericardial tamponade; 2)GCS score <12; 3)septic shock who did not respond to fluid resuscitation or vasopressor infusion(SBP <90 mmHg); 4)Decompensated respiratory acidosis(PH<7.30; 5)Subjects with airway obstruction/dysphagia or swallowing disorders/high risk of aspiration; 6)Subjects with pneumothorax /barotrauma/upper abdominal or thoracic surgery within 1 month; 7)Planned intubation and mechanical ventilation imminent; 9)Subjects with cervical spine injury/impaired hearing or vision/history of claustrophobia; 10)Identifiable nasal or facial deformities; 11)Endotracheal intubation/ mechanical ventilation within 7 days; 12)Subjects with advanced tumour/multiple organ failure; Pregnant or lactating females; 13)Participation in another clinical trial; 14)Any absolute contraindication to helmet CPAP or noninvasive nasal mask.

Design outcomes

Primary

MeasureTime frame
SpO2;

Secondary

MeasureTime frame
Heart rate;Blood Pressure;Respiratory rate;Comfort level evaluation(VAS);

Countries

China

Contacts

Public ContactYuanda Xu

The First Affiliated Hospital of Guangzhou Medical University

xuyuanda@sina.com+86 18928868231

Outcome results

None listed

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