Undetectable Hypotension Episodes in Cesarean Section

NCT05440695 | Completed DMC FDA Device

• 1 other identifier: KA13/33
• Study Type: observational
• Target: 53
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pregnancy Related; Anesthesia; Blood Pressure

Keywords

Anesthesia; Obstetrical; Cesarean section; Arterial pressure; Blood pressure; Newborn

Outcome Measures

Primary Outcomes (1)

• Detection of hypoptensive episodes

  Hypotensive

  Approximately 100minutes/patient (till the end of the C/S).

Secondary Outcomes (17)

• 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 - 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 - 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 - 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 - Intraoperative fluid (ml)

  Approximately 100minutes/patient (till the end of the C/S).

Study Arms (2)

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. After intrathecal injection, systolic, diastolic, and mean blood pressures were measured and were recorded manually at every minute on the CNAP monitor.

Device: Continuous non-invasive arterial pressure (Infinity® CNAPTM, Dräger)

NIBP Group

In the control group, only oscillometric NIBP measurements were done in pregnant women similar to the study group without a CNAP. After intrathecal injection, systolic, diastolic, and mean blood pressures with oscillometric method were set at the frequency of 3 minutes for the first 15 minutes, and at 5-minute intervals thereafter, and were recorded manually.

Interventions

Continuous non-invasive arterial pressure (Infinity® CNAPTM, Dräger) DEVICE

The basic working principle of CNAP is to keep the blood volume of the finger arteries constant by applying an exterior pressure to the vessel wall, that is done by an electronic system controlling the pressure inside a cuff around the finger. The pressure in the cuff, which is needed to keep the volume constant during arterial pulsation, corresponds to the AP.

CNAP Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study group consisted of pregnant women at term, who were scheduled for the elective (planned) C/S under spinal anesthesia in an academic tertiary care unit. Subjects were randomly assigned into 2 groups to receive either CNAP and NIBP or only NIBP.

You may qualify if:

• Pregnant women at term, who were scheduled for the elective (planned) C/S under spinal anesthesia

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asude AYHANt: lead

Related Publications (5)

• Ngan Kee WD. Prevention of maternal hypotension after regional anaesthesia for caesarean section. Curr Opin Anaesthesiol. 2010 Jun;23(3):304-9. doi: 10.1097/ACO.0b013e328337ffc6.

  PMID: 20173633 BACKGROUND

• Ilies C, Bauer M, Berg P, Rosenberg J, Hedderich J, Bein B, Hinz J, Hanss R. Investigation of the agreement of a continuous non-invasive arterial pressure device in comparison with invasive radial artery measurement. Br J Anaesth. 2012 Feb;108(2):202-10. doi: 10.1093/bja/aer394. Epub 2011 Dec 12.

  PMID: 22171358 RESULT

• Ilies C, Kiskalt H, Siedenhans D, Meybohm P, Steinfath M, Bein B, Hanss R. Detection of hypotension during Caesarean section with continuous non-invasive arterial pressure device or intermittent oscillometric arterial pressure measurement. Br J Anaesth. 2012 Sep;109(3):413-9. doi: 10.1093/bja/aes224. Epub 2012 Jul 12.

  PMID: 22798273 RESULT

• Gupta D, Soskin V, Marjanovic M, Amhaz H, Mazumdar A. CONTINUOUS NON-INVASIVE ARTERIAL PRESSURE DEVICE AS AN ADJUNCT TO RECOGNIZE FLUCTUATING BLOOD PRESSURES DURING ELECTIVE CESAREAN SECTION UNDER SUBARACHNOID BLOCKADE (SAB). Middle East J Anaesthesiol. 2016 Feb;23(4):385-400.

  PMID: 27382807 RESULT

• Hahn R, Rinosl H, Neuner M, Kettner SC. Clinical validation of a continuous non-invasive haemodynamic monitor (CNAP™ 500) during general anaesthesia. Br J Anaesth. 2012 Apr;108(4):581-5. doi: 10.1093/bja/aer499. Epub 2012 Feb 3.

  PMID: 22307242 RESULT

Study Officials

• Aynur C FIRAT, M.D.

  Baskent University School of Medicine, Department of Anaesthesiology and Reanimation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Anaethesiology and Reanimation

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: July 1, 2022
• Study Start: February 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: February 1, 2015
• Last Updated: July 1, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The data will become available when the related manuscript is published in a scientific journal. So, the researchers will be able to reach the manuscript whenever they want-upon the regulations of the published journal.
• Access Criteria: Access will be done throughout the journal's website or digital object identifier system (DOI).