ENT Surgery Clinical Trial
Official title:
Einfluss Der Intermittierenden Pneumatischen Kompression Der Unteren Extremitäten Auf Den Intraoperativen Flüssigkeitsbedarf
Verified date | January 2010 |
Source | University Hospital, Bonn |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Interventional |
Fluid restriction has become of great interest in perioperative care. There is, however, a conflict of interest between fluid restriction and hemodynamic stability. The investigators hypothesized that intermittent pneumatic compression may recruit blood from venous capacity vessels of the lower limbs and thus enable fluid restriction without compromising hemodynamic stability.
Status | Completed |
Enrollment | 70 |
Est. completion date | June 2009 |
Est. primary completion date | June 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - minor ENT surgery without anticipated relevant blood loss Exclusion Criteria: - ASA Status > II - contraindication to IPC - unwillingness or inability to give written informed consent |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Medical center of the Rheinische Friedrich Willhelm Univesity of Bonn | Bonn |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bonn | Masimo Corp. (loan of medical devices), Villa Sana GmbH (loan of medical devices) |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intraoperative fluid demand | Intraoperative = from induction of general anesthesia to end of the surgical procedure, length of procedure may vary (expected mean duration= 45 min) | intraoperative | No |
Secondary | hemodynamic stability | intraoperative | No | |
Secondary | local complications of compression therapy | perioperative = from induction of general anesthesia (= beginning of compression therapy) to discharge from the hospital. | perioperative | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01546272 -
Medico-economic Evaluation of Subcutaneous Automatic Resorbable Staples Device
|
Phase 3 | |
Not yet recruiting |
NCT06105346 -
Prevalence of ENT Diseseas
|