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临床试验/NCT07167498
NCT07167498尚未招募不适用

Continuous Remote Vital Sign Monitoring During Labour Analgesia With Remifentanil - a Prospective Observational Study

Nordsjaellands Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
Incidence of SpO₂ 90-93% lasting more than 2 minutes

研究概览

简要总结

Continuous remote vital sign monitoring during labour analgesia with remifentanil - a prospective observational study

Remifentanil PCA represents a well-tolerated, effective and valuable option for labour analgesia, yet its wider implementation is still limited by concerns of opioid side-effects particularly the risk of respiratory depression leading to desaturation, potentially affecting the foetus. Thus, continuous one-to-one observation and monitoring in the delivery room, with the midwife unable to leave the patient unattended, is recommended. Such constant one-to-one monitoring may be challenging in present health-care settings where staffing constraints may limit the implementation of remifentanil as routine obstetric care.

Continuous remote vital sign monitoring to display oxygen saturation (SpO₂), respiratory rate, and heart rate on a handheld device (smartphone), has the potential to address this barrier by allowing the midwife to leave the labour room for short, predefined intervals while maintaining continuous surveillance of maternal vital signs. Such an approach could free staff resources without compromising patient safety. While centralised foetal monitoring (CTG) is standard practice in many units, the application of continuous remote vital sign monitoring for women receiving remifentanil during labour has, to our knowledge, never been formally studied.

Objectives The aim is to study whether remote monitoring during remifentanil patient-controlled analgesia (PCA) for labour affects the incidence of maternal desaturation and other safety outcomes (bradypnoea, bradycardia, and neonatal outcomes, assessed via Apgar scores and umbilical cord pH.) The study will be conducted in a setting where remifentanil PCA is administered for labour analgesia and the midwife is permitted to leave the labour room for intervals of up to 10 minutes while the woman is remotely monitored using a handheld device carried by the midwife. Predefined criteria for when the woman must be accompanied (e.g., if SpO₂ < 94%, supplemental oxygen >2L/min., or decreased consciousness). Outcomes in this group will be compared with a control group where the midwife remains continuously present in the labour room.

详细描述

Introduction Remifentanil, a potent, ultra-short-acting opioid, administered intravenously via patient-controlled analgesia (PCA) has been used for more than a decade in several countries, particularly in Switzerland and at the Ulster Hospital in Ireland. In 2024, remifentanil was formally included as a standard option for labour analgesia in the United Kingdom and incorporated into the guidelines from the National Institute for Health and Care Excellence (NICE). The REMIPCA SAFE Network collaboration has further demonstrated that remifentanil PCA is a safe and effective method for labour analgesia, offering rapid onset, patient autonomy, and high maternal satisfaction (remiPCA.org).

In many European and Anglophone countries, nitrous oxide and epidural analgesia remain the most commonly used pharmacological methods for labour analgesia, while the use of remifentanil is not yet widespread in all settings. Nitrous oxide cause nausea and is under increasing scrutiny due to environmental concerns, while epidural analgesia, although highly effective for pain relief, is more invasive, resource intensive and associated with rare but severe complications.

Remifentanil PCA represents a well-tolerated, effective and valuable option for labour analgesia, yet its wider implementation is still limited by concerns of opioid side-effects particularly the risk of respiratory depression leading to desaturation, potentially affecting the foetus. Thus, continuous one-to-one observation and monitoring in the delivery room, with the midwife unable to leave the patient unattended, is recommended. Such constant one-to-one monitoring may be challenging in present health-care settings where staffing constraints may limit the implementation of remifentanil as routine obstetric care.

Continuous remote vital sign monitoring to display oxygen saturation (SpO₂), respiratory rate, and heart rate on a handheld device (smartphone), has the potential to address this barrier by allowing the midwife to leave the labour room for short, predefined intervals while maintaining continuous surveillance of maternal vital signs. Such an approach could free staff resources without compromising patient safety. While centralised foetal monitoring (CTG) is standard practice in many units, the application of continuous remote vital sign monitoring for women receiving remifentanil during labour has, to our knowledge, never been formally studied.

Objectives The aim is to study whether remote monitoring during remifentanil for labour analgesia affects the incidence of maternal desaturation and other safety outcomes (bradypnoea, bradycardia, and neonatal outcomes, assessed via Apgar scores and umbilical cord pH.) This will be assessed in a setup where remifentanil PCA for labour analgesia is given and the midwife is allowed maximum absence intervals of 10 minutes with predefined criteria for when the woman must be accompanied (e.g., if SpO₂ < 94%, supplemental oxygen >2L/min., or decreased consciousness) and compared with a control group where the midwife is in the labour room continuously.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Incidence of SpO₂ 90-93% lasting more than 2 minutes

时间窗: During labour

During the use of remifentanil for labour analgesia.

次要结局

  • Incidence of SpO2 89-85% lasting more than one minute(During labour)
  • Any incidence of SpO2 < 85%(During labour)
  • Incidence of RR < 9 for ≥5 minutes(During labour)
  • Incidence of neonates with Apgar score < 7(measured 5 minutes after birth)

研究者

发起方
Nordsjaellands Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Patricia Duch

Consultant, MD

Nordsjaellands Hospital

研究点 (1)

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