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临床试验/NCT04192045
NCT04192045已完成不适用

Quality of Recovery From Obstetric Anaesthesia - a Multicentre Study

Guy's and St Thomas' NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 1,638 人开始时间: 2021年10月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,638
试验地点
1
主要终点
• Correlation of ObsQoR with length of hospital stay (LOS) in hours following delivery across multiple centres, particularly ObsQoR score and prediction of prolonged LOS (>1.5 SD) and readmission to hospital.

研究概览

简要总结

Quality of recovery is an important outcome measure in anaesthesia, whilst there are validated tools for this in surgery and regional anesthesia there are no fully validated tools for obstetrics anaesthesia. The aim of this study is to use the Obstetric Quality of Recovery (ObsQoR) score across multiple centres to assess correlation to length of stay and variation for different types of operative and non- operative delivery.

详细描述

An observational survey based study, for 3 consecutive week days, chosen by the local investigating team during a two-week period across multiple centres.

  • Local investigators will complete the survey with each patient who has received anaesthetic intervention from an anaesthetist, 1 day, around 24hrs after delivery in line with their routine anaesthetic follow up.
  • At 30 days, a telephone survey will be conducted with each patient to repeat the ObsQoR survey and ask key questions regarding functional recovery and activities of daily living post delivery.

In addition for a small number of sites, elective caesarean delivery patients will have blood taken at the point of anaesthesia and 24 hours post delivery to assess the immune function and any changes which may predict poorer outcome in these women.

研究设计

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

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Obstetric patients over 18 years old.
  • Intervention occurring after 32/40 gestation.
  • All mothers receiving anaesthesia or anaesthetic analgesia during their peripartum period.

排除标准

  • Unable to comprehend the questions asked
  • Patient refusal
  • Under 32/40 weeks gestation
  • Cervical cerclage insertion or removal, anaesthesia for External Cephalic Verison
  • Neonatal death
  • Non- NHS patients

结局指标

主要结局

• Correlation of ObsQoR with length of hospital stay (LOS) in hours following delivery across multiple centres, particularly ObsQoR score and prediction of prolonged LOS (>1.5 SD) and readmission to hospital.

时间窗: Up to 3 months

During the study the total length of stay in hours will be calculated for participating patients. This will be correlated with the score from the ObsQoR survey tool. In addition the readmission status of the patient will be asked at the subsequent survey combined with the patient's health care record to correlate with the ObsQoR tool score. Where the ObsQoR score is measured between 0-100 and LOS will be in hours. Readmission will be a binary outcome measure

• The relationship between ObsQoR and patient-reported ready for discharge. This will concurrently be determined to account for institutional, non-medical maternal factors neonatal factors that may delay discharge and impact LOS.

时间窗: up to 3 months

The patient will be surveyed using the ObsQoR tool and also asked regarding when they felt they were ready for discharge to take into account the multitude of factors which may impact on the overall length of stay. Where the ObsQoR score is measured between 0-100 and LOS will be in hours.

次要结局

  • • Comparing ObsQoR profiles with differing types of obstetric anaesthesia and delivery method.(up to 3 months)
  • • Variations in ObsQoR scores across differing centres.(up to 3 months)
  • • Impact of patient factors on ObsQoR score.(up to 3 months)
  • • Impact of anaesthetic or obstetric factors on ObsQoR score.(up to 3 months)
  • • Impact of neonatal facts on ObsQoR score.(up to 3 months)
  • • Impact of institutional factors on ObsQoR score.(up to 3 months)
  • • Impact of time of day on ObsQoR score.(up to 3 months)
  • • Impact of anaesthesia provider factors on ObsQoR score.(up to 3 months)
  • • Prediction of patients who are likely to have an ongoing requirement for analgesia.(up to 3 months)
  • • Prediction of patients who are likely to require further follow up in the community or investigation.(up to 3 months)
  • • Prediction of patients' ability to return to normal activities of daily living.(up to 3 months)
  • • Prediction of patients' who are unable to achieve adequate activity levels. As determined by number of steps on mobile phone / activity tracker.(up to 3 months)
  • Assessment of perioperative immune function and response to surgical trauma as a predictor of outcome following elective caesarean delivery.(up to 3 months)
  • Assessment of correlation between ObsQoR scores, EQ-5D and global health visual analogue scale results at 24 hours and 30 days.(up to 30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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