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Comparison of clinical effectiveness between average volume assured pressure support (AVAPS) with BiPAP S/T in chronic obstructive pulmonary disease with acute exacerbation: a randomized clinical trial

Comparison of clinical effectiveness between average volume assured pressure support (AVAPS) with BiPAP S/T in chronic obstructive pulmonary disease with acute exacerbation: a randomized clinical trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20180903004
Enrollment
24
Registered
2018-09-03
Start date
2018-03-05
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) AECOPD Chronic obstructive pulmonary disease Exacerbation None invasive ventilation NIV None invasive positive pressure ventilation NIPPV BiPAP S/T Average Volume Assured Pressure Support AV

Interventions

Patient with AECOPD enrolled to NIV with AVAPS mode ,Patient with AECOPD enrolled to NIV with BiPAP S/T mode
Experimental Device,Active Comparator Device
AVAPS ,BiPAP S/T

Sponsors

Siriraj Hospital
Lead Sponsor
Siriraj Hospital
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >&#44;= 18 years old 2. Patients with COPD presented with respiratory distress meeting at least one of the following criteria &#45; Pulse oximetry < 90% when breathing at room air &#45; Signs of respiratory distress e.g. accessory muscle use &#45; Respiratory rate ≥ 30 breaths/min &#45; ABG show acute respiratory acidosis determined by ED physician

Exclusion criteria

Exclusion criteria: 1. Refusal of treatment 2. Agitation or non&#45;cooperation 3. Facial deformity 4. Obstruction in the upper airway from surgery or trauma 5. Alterations of the central nervous system not related to hypercapnic encephalopathy (GCS <9) 6. Cardiogenic pulmonary edema 7. Pneumothorax 8. Pulmonary thromboembolism 9. Hemoptysis or septic shock 10. Emergency intubation due to acute respiratory failure or cardiopulmonary arrest 11. Hemodynamic instability with systolic pressure below 90 mmHg

Design outcomes

Primary

MeasureTime frame
compare the decrease in degree of dyspnea initial T0 and 60 minutes post intervention Modified Borg scale and numeric rating scale&#44; and dyspnea and comfort scale

Secondary

MeasureTime frame
Respiration rate initial T0 and 60 minutes post intervention time per minute,SpO2 initial T0 and 60 minutes post intervention %/by portable machine,NIV failure initial T0 and 60 minutes post intervention yes/no,GCS initial T0 and 60 minutes post intervention number 3 to 15,PaCO2 initial T0 and 60 minutes post intervention percentage/arterial blood gas,Heart rate initial T0 and 60 minutes post intervention beat per minute

Countries

Thailand

Contacts

Public ContactChok Limsuwat

Mahidol university&#44; Siriraj Hospital

chok049@gmail.com0815595756

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026