Track topics on Twitter Track topics that are important to you
Maternal hypothermia is very frequent after caesarean delivery under spinal anaesthesia and should be prevented, as it induces discomfort and increases the risk of postoperative complications. Several modalities of active warming have been explored, with contrasting results. EnFlow® IV Fluid warming system offers effective and safe IV fluid warming without discomfort, and is very easy to use. The investigators hypothesize that this device can efficiently prevent hypothermia after caesarean section. The purpose of this study is to determine whether active fluid warming reduces the occurrence of maternal hypothermia after scheduled caesarean section, as compared with no active warming. The investigators plane to conduce a double-blinded randomized controlled trial. Seventy women undergoing scheduled caesarean section under spinal anaesthesia in 3 different maternity units will be included. The primary outcome is the occurrence of maternal hypothermia (<36.0°C) on admission to the post anaesthesia care unit. The secondary outcomes are perioperative maternal hypothermia, maternal thermal discomfort, maternal recovery and neonatal well-being
Hypothermia is a well-known complication of general and neuraxial anaesthesia. After a caesarean section under spinal anaesthesia, 30 to 40% of the mothers have a core temperature <36°C. Perioperative hypothermia induces maternal thermal discomfort and shivering, but also increases the amount of blood loss and the risks of postoperative wound infections and cardiac complications. In addition, maternal hypothermia may also have an impact on neonatal outcomes. Prevention of maternal hypothermia in women scheduled for caesarean delivery is consequently necessary, and is an important part of enhanced recovery after surgery. Active warming is efficient in preventing postoperative hypothermia. Forced-air warming is the most commonly used modality of active warming. However forced-air warming should be applied for at least 60 minutes to be efficient. As surgical duration for a caesarean is lower than one hour, this technic does not appear really appropriate in this context. In addition, upper body forced-air warming is uncomfortable for women and can interfere with bonding. Consequently forced-air warming is not generally used during caesarean delivery. Warmed IV fluid is another option to prevent perioperative hypothermia, but with contrasting results, depending mainly on the device and on the amount of perioperative fluids infusion. Co-loading IV fluid is recommended to prevent maternal hypotension induced by spinal anaesthesia in the context of caesarean delivery. The device enFlow®, routinely used in scheduled surgery, is able to warm IV fluid administered with high flows, such as in co-loading IV fluid. But the efficiency of enFlow® to prevent maternal hypothermia has never been explored in the context of caesarean section under spinal anaesthesia with co-loading.
The investigators hypothesized that warmed IV fluid administered in co-loading with enFlow® decreases the incidence of postoperative maternal hypothermia after caesarean section under spinal anaesthesia.
The investigators will perform a double blinded randomized controlled trial comparing active IV warming with enFlow® versus placebo.
After obtaining written informed consent from the patients, 70 pregnant women ASA status 1 or 2 and scheduled for caesarean delivery will be enrolled and randomized into two groups: active IV fluid warming vs no active warming. Written informed consent will be obtained before randomisation using an Internet based randomisation system. Participants will be randomized just after their arrival in the operative room. The clinicians in charge of the patients, the researcher and the woman will be blinded. In the operative room, a venous cannula will be inserted into the forearm, and an infusion of Ringer's lactate solution fluids will be initiated. An enFlow® device will be placed on the IV for all the patients, but turned on only in the group active warming. The device will be hidden in all the patients. Every patient will have a spinal anaesthesia in sitting position with hyperbaric bupivacaine 10mg, sufentanil 3µg and morphine 100µg. An IV co loading with Ringer-Lactate 1000 ml will be started at the beginning of the spinal administration. All the women will be monitored using heart rate, continuous SpO2, non-invasive arterial blood pressure every 1-minute until the baby is born, and then every 5 minutes. Maternal arterial hypotension will be corrected with ephedrine or phenylephrine as appropriate. All the women will receive carbetocin 100µg just after baby extraction. While in the operative room, all the data will be collected on a standardized data collection sheet. In case of maternal temperature <35°C during surgery, an active warming blanket will be used. The enFlow® device will be taken off at the end of the surgery just before leaving the operative room.
In addition, postoperative data will be collected during the admission to the post-anaesthesia care unit (PACU). In case of maternal temperature <36°C in the PACU, a warming blanket will be used.
The sample size calculation revealed that 62 participants were required to ensure that a 30% decrease in the incidence of postoperative maternal hypothermia will be detected (power = 0.9 ; α= 0,05). The investigators decided to enroll 70 women because of the risks of secondary exclusions and of lost of follow up.
enFlow® IV fluid warmer
Cochin Hospital, Port-Royal Maternity
Not yet recruiting
Assistance Publique - Hôpitaux de Paris
Published on BioPortfolio: 2018-07-17T11:27:12-0400
Hypothermia contributes to a significant portion of neonatal deaths. Kangaroo Mother Care (KMC) is a safe and effective method of warming; however, it is not always feasible, for example i...
Study of adult patients with severe all-cause trauma having a body temperature less than 36°Celsius (C) that is managed by a Mobile Emergency Service team and oriented towards a Vital Eme...
The present study aims at testing if the TherMax blood warmer is more accurate and reliable in reaching and maintaining chosen target temperature during continuous renal replacement therap...
The majority of women (> 60%) developed hypothermia and shivering during cesarean delivery. Core hypothermia may be associated with a number of adverse outcomes in patients, including shiv...
The purpose of this study is to compare three radiant warmer beds that contain different computer heating software and different bed styles. Radiant warmers are used in many neonatal inten...
Hypothermia occurs in up to 20% of perioperative patients. Systematic postoperative temperature monitoring is not a standard of care in Brazil and there are few publications about temperature recovery...
The amount and type of intraoperative fluid in patients with pulmonary resection is currently controversial. This study evaluated the dose-response relationship between intraoperative fluid administra...
We read with interest A Different View entitled, "Major concerns about late hypothermia study" by Walløe, Hjort and Thoresen (1) which raised questions about a randomized clinical trial of initiating...
Therapeutic hypothermia is partially protective for neonatal hypoxic-ischemic encephalopathy (HIE). Damage to the white matter tracts is highly associated with adverse outcomes after HIE, but the effe...
Accidental hypothermia following trauma is an independent risk factor for mortality. However, in most experimental studies, hypothermia clearly improves outcome. We hypothesized that slow rewarming is...
Abnormally low BODY TEMPERATURE that is intentionally induced in warm-blooded animals by artificial means. In humans, mild or moderate hypothermia has been used to reduce tissue damages, particularly after cardiac or spinal cord injuries and during subsequent surgeries.
A nonsteroidal anti-inflammatory agent with potent analgesic and antiarthritic properties. It has been shown to be effective in the treatment of OSTEOARTHRITIS; RHEUMATOID ARTHRITIS; ankylosing SPONDYLITIS; and in the alleviation of postoperative pain (PAIN, POSTOPERATIVE).
Fluid collected from nipple by gentle aspiration. The fluid contains cells and extracellular fluid from the breast ductal epithelium.
Discharge of cerebrospinal fluid through a hole through the skull bone most commonly draining from the nose (CEREBROSPINAL FLUID RHINORRHEA) or the ear (CEREBROSPINAL FLUID OTORRHEA).
Abdominal symptoms after removal of the GALLBLADDER. The common postoperative symptoms are often the same as those present before the operation, such as COLIC, bloating, NAUSEA, and VOMITING. There is pain on palpation of the right upper quadrant and sometimes JAUNDICE. The term is often used, inaccurately, to describe such postoperative symptoms not due to gallbladder removal.
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...
An anesthesiologist (US English) or anaesthetist (British English) is a physician trained in anesthesia and perioperative medicine. Anesthesiologists are physicians who provide medical care to patients in a wide variety of (usually acute) situations. ...
Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...