Study to Detect Hypotensive Episodes During Spinal Anesthesia for Cesarean Section Using a Noninvasive Continuous Device
This study has been completed.
Sponsor:
University of Schleswig-Holstein
Information provided by:
University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT01157520
First received: July 6, 2010
Last updated: July 8, 2010
Last verified: July 2010
| Tracking Information | |
|---|---|
| First Received Date ICMJE | July 6, 2010 |
| Last Updated Date | July 8, 2010 |
| Start Date ICMJE | June 2009 |
| Primary Completion Date | June 2010 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE | Not Provided |
| Original Primary Outcome Measures ICMJE | Not Provided |
| Change History | Complete list of historical versions of study NCT01157520 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Study to Detect Hypotensive Episodes During Spinal Anesthesia for Cesarean Section Using a Noninvasive Continuous Device |
| Official Title ICMJE | Hypotensive Episodes During Cesarean Section Detected by a Continuous Non-invasive Arterial Pressure Measurement Device Are Missed by the Oscillometric Blood Pressure Measurement |
| Brief Summary | Hypotension after spinal anesthesia for Cesarean section occurs in up to 90% usually under five minutes after local anesthetics administration. These changes are poorly depicted by oscillometric measurements. The investigators hypothesized, that a continuous noninvasive device detects more hypotensive periods with lower blood pressures. |
| Detailed Description | Not Provided |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Not Provided |
| Sampling Method | Probability Sample |
| Study Population | elective Cesarean section under spinal anesthesia |
| Condition ICMJE | Hypotension |
| Intervention ICMJE | Not Provided |
| Study Group/Cohort (s) | Cesarean
Women scheduled for elective Cesarean section under spinal anesthesia |
| Publications * | Not Provided |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | Not Provided |
| Completion Date | June 2010 |
| Primary Completion Date | June 2010 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female |
| Ages | 18 Years to 45 Years |
| Accepts Healthy Volunteers | Not Provided |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Not Provided |
| Administrative Information | |
| NCT Number ICMJE | NCT01157520 |
| Other Study ID Numbers ICMJE | CNAP_Sectio |
| Has Data Monitoring Committee | No |
| Responsible Party | Not Provided |
| Study Sponsor ICMJE | University of Schleswig-Holstein |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | University of Schleswig-Holstein |
| Verification Date | July 2010 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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