Hemodynamic Monitoring in Women Throughout Cesarean Sections
Maternal Hemodynamic Monitoring in Women Undergoing Cesarean Section by Use of NICaS Cardiac Impedance
In this study we would like to monitor cardiac output by the use of NICAS bioimpedance in women undergoing cesarean section delivery.
This study is a purely observational study, it will not have any clinical intervention nor will it interfere with standard cesarean delivery protocols in any way. This study's primary objective is to evaluate how spinal and general anesthesia influences cardiac output during cesarean section deliveries. Secondary endpoints is whether the hemodynamic changes as measured in cardiac output correlate with women's pain, measured by a visual analogue scale(VAS) from o-10. (0=representing no pain at all, 10= worse pain imaginable)
調査の概要
詳細な説明
This is a prospective, single center study which will be conducted at the Rabin Medical Center (Beilinson Campus), Petach Tikva, Israel, a tertiary university hospital. The Institutional Review Board has approved this study.
Two hundred women undergoing cesarean sections will be enrolled after filling out an informed consent form. Women will be recruited half an hour preoperatively in the women's surgery waiting room when they aren't experiencing any pain, and aren't under any sedatives.
Following obtaining an informed consent maternal cardiac output will be monitored.
The monitoring will be carried out using non invasive NICaS cardiac impedance by the use of two electrodes stickers which are pasted on the wrists for about 6 minutes.
Monitoring will be done with women lying down or sitting up half an hour preoperatively (in the woman's surgery waiting room) intraoperatively, and postoperatively in the post anesthesia care unit (PACU).
Preoperative data will be compared to intraoperative and postoperative data, and will be analyzed in order to evaluate the dynamic cardiac output changes in women undergoing cesarean sections.
Recorded data will include:
- Demographic and obstetric - age, weight, height, current hemoglobin, co-morbidities, regular medication and other obstetric data.
- Cardiovascular risk factors - a family history of cardiovascular disease, smoking, BMI
- Obstetric history - obstetric background (history of gestational diabetes, preeclampsia, intrauterine growth restriction (IUGR), stillbirths or placental abruption).
- Threshold of pain according to VAS It should be emphasized that the conduct of the study will not interfere in with cesarean delivery protocol in any way.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
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Petach tikvah、イスラエル
- Beilinson Hospital
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- All women undergoing cesarean section in Beilinson Hospital following obtaining written informed consents forums with the ability to comply to the study requirements will be included in our study.
Exclusion Criteria:
- Women under age 18 , and women who don't understand the inform consent form will be excluded from participating.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Parturients undergoing cesarean section
Healthy parturients, hypertensive parturients and parturients suffering from preeclampsia above 18 undergoing cesarean section deliveries .
|
Hemodynamic monitoring will be carried out using non invasive NICaS cardiac impedance by the use of two electrodes stickers which are pasted on the wrists for about 6 minutes. Monitoring will be done with women lying down or sitting up half an hour preoperatively (in the woman's surgery waiting room) intraoperatively, and postoperatively in the PACU. Preoperative data will be compared to intraoperative and postoperative data, and will be analyzed in order to evaluate the dynamic cardiac output changes in women undergoing cesarean sections. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Hemodynamic changes in cesarean section as measured by NICaS parameters.
時間枠：A year
|
This study's primary objective is to evaluate how anesthesia influences cardiac output during cesarean section deliveries
|
A year
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Hemodynamic changes measured by NICaS parameters and their correlation with pain in women undergoing cesarean sections as measured by VAS.
時間枠：A year
|
A year
|
協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- Langesaeter E, Dyer RA. Maternal haemodynamic changes during spinal anaesthesia for caesarean section. Curr Opin Anaesthesiol. 2011 Jun;24(3):242-8. doi: 10.1097/ACO.0b013e32834588c5.
- McDonald SD, Malinowski A, Zhou Q, Yusuf S, Devereaux PJ. Cardiovascular sequelae of preeclampsia/eclampsia: a systematic review and meta-analyses. Am Heart J. 2008 Nov;156(5):918-30. doi: 10.1016/j.ahj.2008.06.042. Epub 2008 Oct 2.
- Critchley LA, Critchley JA. A meta-analysis of studies using bias and precision statistics to compare cardiac output measurement techniques. J Clin Monit Comput. 1999 Feb;15(2):85-91. doi: 10.1023/a:1009982611386.
- Critchley LA, Lee A, Ho AM. A critical review of the ability of continuous cardiac output monitors to measure trends in cardiac output. Anesth Analg. 2010 Nov;111(5):1180-92. doi: 10.1213/ANE.0b013e3181f08a5b. Epub 2010 Aug 24.
- Dyer RA, Piercy JL, Reed AR, Lombard CJ, Schoeman LK, James MF. Hemodynamic changes associated with spinal anesthesia for cesarean delivery in severe preeclampsia. Anesthesiology. 2008 May;108(5):802-11. doi: 10.1097/01.anes.0000311153.84687.c7.
- Dyer RA, James MF. Maternal hemodynamic monitoring in obstetric anesthesia. Anesthesiology. 2008 Nov;109(5):765-7. doi: 10.1097/ALN.0b013e31818a3825. No abstract available.
- Langesaeter E, Rosseland LA, Stubhaug A. Continuous invasive blood pressure and cardiac output monitoring during cesarean delivery: a randomized, double-blind comparison of low-dose versus high-dose spinal anesthesia with intravenous phenylephrine or placebo infusion. Anesthesiology. 2008 Nov;109(5):856-63. doi: 10.1097/ALN.0b013e31818a401f.
- Langesaeter E. Is it more informative to focus on cardiac output than blood pressure during spinal anesthesia for cesarean delivery in women with severe preeclampsia? Anesthesiology. 2008 May;108(5):771-2. doi: 10.1097/ALN.0b013e31816bbe04. No abstract available.
- Dennis AT, Dyer RA. Cardiac output monitoring in obstetric anaesthesia. Int J Obstet Anesth. 2014 Feb;23(1):1-3. doi: 10.1016/j.ijoa.2013.11.001. Epub 2013 Nov 13. No abstract available.
- Bliacheriene F, Carmona MJ, Barretti Cde F, Haddad CM, Mouchalwat ES, Bortolotto MR, Francisco RP, Zugaib M. Use of a minimally invasive uncalibrated cardiac output monitor in patients undergoing cesarean section under spinal anesthesia: report of four cases. Rev Bras Anestesiol. 2011 Sep-Oct;61(5):610-8, 334-8. doi: 10.1016/S0034-7094(11)70072-1. English, Portuguese, Spanish.
- Langesaeter E, Gibbs M, Dyer RA. The role of cardiac output monitoring in obstetric anesthesia. Curr Opin Anaesthesiol. 2015 Jun;28(3):247-53. doi: 10.1097/ACO.0000000000000190.
- Dyer RA, Reed AR, van Dyk D, Arcache MJ, Hodges O, Lombard CJ, Greenwood J, James MF. Hemodynamic effects of ephedrine, phenylephrine, and the coadministration of phenylephrine with oxytocin during spinal anesthesia for elective cesarean delivery. Anesthesiology. 2009 Oct;111(4):753-65. doi: 10.1097/ALN.0b013e3181b437e0.
- Habib AS. A review of the impact of phenylephrine administration on maternal hemodynamics and maternal and neonatal outcomes in women undergoing cesarean delivery under spinal anesthesia. Anesth Analg. 2012 Feb;114(2):377-90. doi: 10.1213/ANE.0b013e3182373a3e. Epub 2011 Nov 21.
- Tihtonen K, Koobi T, Yli-Hankala A, Huhtala H, Uotila J. Maternal haemodynamics in pre-eclampsia compared with normal pregnancy during caesarean delivery. BJOG. 2006 Jun;113(6):657-63. doi: 10.1111/j.1471-0528.2006.00931.x.
- Melchiorre K, Sutherland GR, Baltabaeva A, Liberati M, Thilaganathan B. Maternal cardiac dysfunction and remodeling in women with preeclampsia at term. Hypertension. 2011 Jan;57(1):85-93. doi: 10.1161/HYPERTENSIONAHA.110.162321. Epub 2010 Nov 22.
- Chaffin DG, Webb DG. Outcomes of pregnancies at risk for hypertensive complications managed using impedance cardiography. Am J Perinatol. 2009 Nov;26(10):717-21. doi: 10.1055/s-0029-1223283. Epub 2009 May 18.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 0512-15-RMC
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
In this study the investigators would like to monitor cardiac output by the use of NICaS bioimpedance in women undergoing cesarean section delivery.
This study is a purely observational study, it will not have any clinical intervention nor will it interfere with standard cesarean delivery protocols in any way.
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