Can We Detect Hypotension Episodes That Were Not Identified in the Non-Invasive Blood Pressure During Cesarean Section? A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 53
- Primary Endpoint
- Detection of hypoptensive episodes
Study Overview
Brief Summary
In order to evaluate the efficacy and necessity of continuous non-invasive arterial pressure (CNAP) by comparing it with non-invasive blood pressure (NIBP) in order to understand whether it has advantages over oscillometric technique for detection of hypotensive episodes in healthy pregnant women who underwent cesarean section (C/S) under neuraxial anesthesia. This prospective study will evaluate healthy pregnant women at term, who were scheduled for elective C/S under spinal anesthesia. Subjects were randomly assigned into 2 groups to receive either CNAP and NIBP or only NIBP. A thirty percent decrease in systolic blood pressure from either baseline or the measured values in the first two minutes, or if the systolic blood pressure was less than 90mmHg, is considered hypotension. Pre-, peri- and post-operative specifications, newborn characteristics, and complications were recorded and compared.
Detailed Description
The aim of the study was to test the hypothesis that whether continuous non-invasive arterial pressure (CNAP) is able to identify the hypotensive episodes that were not disclosed (or identified) in the non-invasive blood pressure (NIBP), or, detects earlier compared to NIBP in healthy pregnant women who underwent C/S under neuraxial anesthesia. We also evaluated the association between monitoring CNAP vs NIBP and outcomes as a secondary endpoint.
At least 40 participants were planned to be included in each arm, considering the unforeseen technical problems (in accordance with the "Power and Sample Size Program", the inclusion of at least 29 patients was necessary for both groups for a power 0.80, alpha 0.05 and a standard deviation of 0.04).
Healthy pregnant women at term, who were scheduled for the elective C/S under spinal anesthesia in an academic tertiary care unit between February 2014 and February 2015, comprised the study group. The exclusion criteria for the study were; 1) emergency C/S, 2) simultaneous gynecological interventions with C/S such as myomectomy, tubal ligation, placental abnormalities, etc., 3) if C/S was performed in failure of labor to progress, 4) the presence of any systemic disease, 5) preeclampsia or eclampsia, 6) drug hypersensitivity - for the ones that are used in the C/S -, 7) multiple pregnancies, 8) those pregnancies with any intrauterine fetal pathology, and 9) more than two missing consecutive NIBP readings.
Subjects were randomly assigned into 2 groups to receive either CNAP and NIBP or only NIBP. CNAP finger cuff (Infinity® CNAPTM, Dräger) was used for calibrate the device before the first measurement then calibration was repeated every 30 minutes.
In the CNAP group, the CNAP finger cuff and NIBP cuff were on the same arm of the patient while the intravenous catheter was on the contralateral side. In the control group, only oscillometric NIBP measurements were done in pregnant women similar to the study group without a CNAP.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Pregnant women at term, who were scheduled for the elective (planned) C/S under spinal anesthesia
Exclusion Criteria
- •emergency C/S,
- •simultaneous gynecological interventions with C/S such as myomectomy, tubal ligation, placental abnormalities, etc.,
- •C/S that was performed in failure of labor to progress,
- •the presence of any systemic disease,
- •preeclampsia or eclampsia,
- •hypersensitivity to drugs that are used in C/S,
- •multiple pregnancies,
- •pregnancies with any intrauterine fetal pathology,
- •cases with more than two missing consecutive NIBP readings.
Outcomes
Primary Outcomes
Detection of hypoptensive episodes
Time Frame: Approximately 100minutes/patient (till the end of the C/S).
Hypotensive
Secondary Outcomes
- The association between monitoring CNAP vs NIBP and other related outcomes - Skin incision time (minutes)(Approximately 100minutes/patient (till the end of the C/S).)
- The association between monitoring CNAP vs NIBP and other related outcomes - Cuff discomfort(Approximately 100minutes/patient (till the end of the C/S).)
- The association between monitoring CNAP vs NIBP and other related outcomes - Newborns' Blood Gas Analysis(At the time of birth - through study completion, an average of 1 year)
- The association between monitoring CNAP vs NIBP and other related outcomes - Anesthesia time to reach T4 level(Approximately 100minutes/patient (till the end of the C/S).)
- The association between monitoring CNAP vs NIBP and other related outcomes - Time to leave the operating theater (minutes)(Approximately 100minutes/patient (till the end of the C/S).)
- The association between monitoring CNAP vs NIBP and other related outcomes - Bolus of 200 ml Ringer's lactate solution(Approximately 100minutes/patient (till the end of the C/S).)
- The association between monitoring CNAP vs NIBP and other related outcomes - Newborns' APGAR score(After birth at 5th minutes)
- The association between monitoring CNAP vs NIBP and other related outcomes - Uterine incision time (minutes)(Approximately 100minutes/patient (till the end of the C/S).)
- The association between monitoring CNAP vs NIBP and other related outcomes - Intraoperative fluid (ml)(Approximately 100minutes/patient (till the end of the C/S).)
- The association between monitoring CNAP vs NIBP and other related outcomes - The need and amount of ephedrine used(Approximately 100minutes/patient (till the end of the C/S).)
- The association between monitoring CNAP vs NIBP and other related outcomes - Vomiting(After C/S - early postoperative period - through study completion, an average of 1 year)
- The association between monitoring CNAP vs NIBP and other related outcomes - Nausea(After C/S - early postoperative period - through study completion, an average of 1 year)
- The association between monitoring CNAP vs NIBP and other related outcomes - Length of Hospitalization (days)(Length of Hospitalization - through study completion, an average of 1 year)
Investigators
Asude AYHANt
Assistant Professor of Anaethesiology and Reanimation
Baskent University