Comparison of 'Sip Til Send' Regimens Prior to Elective Caesarean Delivery Using Bedside Gastric Ultrasound: a Randomized Study Comparing Water With Carbohydrate-rich Drink
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- 24-hour Obstetric Quality of Recovery-10 (ObsQoR-10) scores
研究概览
简要总结
'Sip Til send' is a liberal drinking policy that replaces fasting before a caesarean delivery, meaning that women waiting in hospital can freely drink sips of water until they are called from the ward for their delivery. Studies has shown that 'Sip Til send' is safe and it improves the experience around surgery. Separate from this, drinking carbohydrate-rich drinks at specified time intervals before surgery is also recommended by international guidelines as part of a package of care aimed at enhancing recovery from surgery, and studies demonstrate that carbohydrate drinks significantly lower hunger sensation before caesarean delivery. The aim of this study is to combine these two interventions and compare the effects of sipping water against sipping carbohydrate drinks whilst waiting for a caesarean delivery and look at the stomach contents before delivery to ensure it is a safe practice and look at how women rate the quality of their recovery to see which practice is preferred. We will recruit women due to have an elective caesarean delivery whilst awake with a spinal anaesthetic at the Rotunda Hospital and only include those who are fully fasted on their arrival and would be candidates for the current 'Sip Til Send' policy. They will then be assigned to one of two groups, the "water" group who will be encouraged to sip water whilst waiting for surgery, and the "carbohydrate" group who will be encouraged to sip a standardised carbohydrate-rich drink instead. Using a bedside ultrasound machine, we will image the stomach and estimate the volume of liquid contents on two occasions; first, following recruitment to the study when fully fasted and before starting 'Sip Til Send', and second is immediately prior to surgery. Fluid intake will be closely monitored, and all participants will be asked to complete a short questionnaire the day after their delivery that asks them to rate aspects of their recovery. Participants and their newborns will not undergo any additional invasive testing for the study. Participants and their newborns will not undergo any additional invasive testing for the study, but consent will be sought to test women's urine for ketones (collected from the catheter bag during surgery). Medical notes will also be looked at after discharge to identify adverse outcomes such as nausea or vomiting during surgery and low blood sugar in the newborn. The study should run for approximately 3 to 6 months.
详细描述
This study is a prospective randomized single-blinded study. Randomisation to intervention which will be "water" group and "carbohydrate" group. Pregnant women cannot be blinded to the intervention, but the healthcare workers and the investigators will be blinded to the intervention.
This study will incorporate clinical practice protocols that are already in place at the Rotunda hospital. The enhanced recovery guidelines encourage consumption of carbohydrate drinks prior to arrival at hospital for surgery. This protocol was superseded by the introduction of 'Sip Til Send' with water with an aim to reduce fasting times after arrival at hospital, but adherence with both practices is variable.
The study intervention is the provision of water or a standard carbohydrate-rich drink which the participants may sip to comfort at a maximum rate of 1 cup (170ml) per hour whilst waiting in hospital for an elective CD planned under neuraxial anaesthesia. The water group represent the control or standard practice group as this is in line with current hospital policy. The carbohydrate group represent the interventional group and will utilise the same carbohydrate drinks available for enhanced recovery.
Eligible participants booked to undergo an elective CD will be recruited on the day of surgery by a member of the research team. Consideration will depend on the research team availability, expected fasting time of more than 1 hour and full adherence of European fasting guidelines at the time of study entry (6 hours for solids and 2 hours for liquids). Following recruitment, written consent is obtained and a 'fasting' gastric ultrasound will be performed in a standardised manner prior to randomisation. If a Perlas grade 2 antrum is encountered, this will be assumed to represent a full stomach (>1.5ml/kg) and the potential participant be removed from the study. To mitigate any further risk, they will be advised to fully fast, not be offered 'Sip Til Send' and the anaesthesiologist in charge of their clinical care will be informed. Any women in whom adequate views of the gastric antrum cannot be obtained in both positions will also be removed from the study. All other participants will then be randomized into the study.
Following group allocation, women will be provided with a weighed jug of water or carbohydrate drink, a 170ml cup and written instructions stating that they may drink continually to comfort up to 1 cup and hour and information on how to refill if required. Prior to their CD, any remaining drink will be weighed to calculate to volume consumed (assuming a liquid density of 1mg/ml) and participants will undergo a second gastric ultrasound scan immediately prior to surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Planned caesarean delivery under regional anaesthesia
- •Adhered to national fasting guidance of 6 hours for food and 2 hours for clear fluids
- •Eligible for Sip Til Send
排除标准
- •Planned general anaesthesia
- •Emergency or urgent caesarean delivery
- •Not fasted at time of recruitment
- •Unable to visualise stomach or Perlas 2 stomach identified at time of recruitment
- •Obesity of BMI >40
- •Previous upper GI or bariatric surgery
- •Age <18 years
- •Insulin dependent diabetes mellitus (type 1 or 2)
- •Gestational diabetes
研究组 & 干预措施
'Sip Til Send' with water
The "water" group who will be encouraged to sip at a maximum rate of 1 cup (170ml) per hour whilst waiting in hospital for an elective CD planned under neuraxial anaesthesia. The water group represent the control or standard practice group as this is in line with current hospital policy.
干预措施: The "water group" (Drug)
'Sip Til Send' with carbohydrate-rich drinks
the "carbohydrate" group will be encouraged to sip a standardised carbohydrate-rich drink ,flavoured clear, carbohydrate drink " Nutricia preOp".
干预措施: The carbohydrate group represent the interventional group and will utilise the standard carbohydrate-rich drink (Drug)
结局指标
主要结局
24-hour Obstetric Quality of Recovery-10 (ObsQoR-10) scores
时间窗: From enrollment to around 24 hours after delivery (+/- 4 hours).
Compare the 24-hour quality of recovery scores : At around 24 hours after delivery (+/- 4 hours), women will be approached for a single follow-up visit where they will be asked to complete an obstetric-specific quality of recovery score (ObsQoR-10). This is scale from 0 to 100, with a higher number indicating a better quality of recovery.
Gastric antrum CSA
时间窗: From enrollment until just before their cesarean delivery.
Compare the gastric antrum CSA immediately prior to caesarean delivery: 'fasting' gastric ultrasound will be performed in a standardised manner prior to randomization, Prior to their CD, participants will undergo a second gastric ultrasound scan immediately prior to surgery.
次要结局
- Estimated residual gastric volume before CD(From enrollment until just before their cesarean delivery.)
- Incidence of a full stomach assessed by quantitative ultrasound measurements(From enrollment until just before their cesarean delivery.)
- Qualitative ultrasound guided incidence of a full stomach(From enrollment until just before their cesarean delivery.)
- Compare the maternal urinary ketones during caesarean delivery(From enrollment until just before their cesarean delivery.)
- Gastric antrums CSA Vs Estimated gastric volumes(From enrollment until just before their cesarean delivery.)
- Incidence of treated neonatal hypoglycaemia(Immediately after birth)
研究者
Ryan Howle
Consultant Anaesthesiologist
The Rotunda Hospital
