Safety of NHF in Acute Hypercapnic AECOPD Clinical Trial
Official title:
NHF in Acute Hypercapnic Acute Exacerbation of COPD
| NCT number | NCT03523481 |
| Other study ID # | 2 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 15, 2018 |
| Est. completion date | May 30, 2018 |
| Verified date | June 2018 |
| Source | University of Leipzig |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Patients with AECOPD and NIV failure and in absence will be treated with NHF device. Inclusion criteria are pH < 7,38 and pCO2 > 45 mm Hg. Patients were treated if pH >7,38 or refusal of therapy.
| Status | Completed |
| Enrollment | 38 |
| Est. completion date | May 30, 2018 |
| Est. primary completion date | May 30, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - pH < 7,38 - hypercapnic AECOPD Exclusion Criteria: - Need of intubation |
| Country | Name | City | State |
|---|---|---|---|
| Germany | University of Leipzig | Leipzig |
| Lead Sponsor | Collaborator |
|---|---|
| Jens Bräunlich, MD |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | pH | Increase in pH | up to 24 hours | |
| Secondary | pCO2 | Decrease in pCO2 | up to 24 hours |