ECHIDNA: A study in infants having inguinal hernia repair surgery looking at their oxygen saturation levels before and after surgery using a Nonin oximeter
Evaluating Children undergoing inguinal Hernia surgery Investigating Desaturations using Nonin oximeter Assessments (ECHIDNA)
Perth Children's Hospital
60 participants
May 26, 2023
Interventional
Conditions
Summary
Surgical repair of an inguinal hernia is a common procedure in early childhood. The incidence of inguinal hernia’s is inversely related to an infant’s birth weight, gestational age, and is more common in boys. Prematurity (less than 36 weeks gestational age) is identified as a major risk factor for the development of inguinal hernias, with approximately 30% of preterm infants diagnosed with an inguinal hernia. Most preterm infants diagnosed with inguinal hernias in our institution will undergo surgical repair prior to discharge from the neonatal intensive care unit (NICU). It is well documented that preterm infants undergoing general anaesthesia have an increased risk of cardiorespiratory events including apnoea and bradycardia. Respiratory adverse events are common in paediatric anaesthesia and comprise more than three quarters of all critical incidents and half of all unplanned admission to paediatric intensive care unit. While studies have looked at the post-operative apnoeas and the risk associated with apnoea in infants, there are few studies that have explored the respiratory trajectory of these patients undergoing inguinal hernia repairs. In this study, oximetry and apnoeas will be measured both pre- and post-operatively, along with transcutaneous carbon dioxide levels on the night of surgery to investigate the impact of anaesthesia and surgery on these young infants. Particularly, identifying infants at increased risk of respiratory complications through pre-operative continuous pulse oximetry may potentially reduce morbidity and help guide clinicians on the optimal allocation of resources including the length and intensity of post-operative monitoring required, and ultimately the anaesthesia management plan. This is a pilot study to assess the feasibility of investigating the respiratory profile (deviation from baseline SpO2, desaturation events, apnoeas, carbon dioxide levels) in infants (up to 6 months corrected age) undergoing inguinal hernia repair to assess the recovery profile after surgery under general anaesthesia and/ or regional block at Perth Children’s Hospital, a tertiary specialist paediatric centre to inform the planning of a larger trial. The study will also evaluate the rate of participant recruitment and rate of adherence to the protocol.
Eligibility
Plain Language Summary
Simplified for easier understanding
This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
A multi-centre pilot study will be carried out at Perth Children’s Hospital and King Edward Memorial Hospital in Western Australia. Participants will be recruited prior to the day of their surgery. Informed consent will be via eConsent in Redcap or via written paper versions of the parent information sheet and consent form. Once informed voluntary consent is obtained, the research team will provide the family with the Nonin WristOx pulse oximeter and consumables (batteries, fixomull, sensor) for the child to wear for 48 continuous hours prior to inguinal hernia repair surgery. Parents will be provided with an instruction sheet on how to apply the device and troubleshoot common problems. If the patient is a current inpatient at Perth Children’s Hospital or in the neonatal intensive care unit at King Edward Memorial Hospital, then the Nonin WristOx pulse oximeter and consumables will be provided to the nursing staff and will be worn in addition to the normal ward monitoring. If the participant is an inpatient at Perth Children’s Hospital prior to their surgery, transcutaneous carbon dioxide (tcCO2) monitoring will be applied using the SenTec digital monitoring device and tcCO2 data will be collected for 12 hours pre-operatively as a baseline. Blood Oxygen levels (SpO2) will be measured by the Nonin wrist-worn oximeter device (WristOx 3150, Nonin Medical, Plymouth, MN) for 48 hours pre- and post the operation. The Nonin WristOx 3150 is a small, lightweight pulse oximeter that can be placed on the side of the cot, with the probe applied to the infants’ toe or foot. This type of device can be used in hospital and at the patient’s home as it is easy to use and is activated when the probe is connected. To assess the whole ventilatory profile, transcutaneous carbon dioxide levels (tcCO2) will be measured by the non-invasive digital monitoring system, SenTec (SenTec, Lincoln, RI 02685 United States). On the day of surgery, all children will be anaesthetised in accordance with the Australian New Zealand College of Anaesthetists safety standards. Relevant information on the patient's demographics, medical history and perioperative management will be collected. Once returned to the ward, all children will have tcCO2 monitoring postoperatively, a probe will be applied to the patient’s forehead or shoulder on the first night after surgery. The tcCO2 device will record for a maximum of 12 hours overnight and will be connected to the patient within an hour of their normal bedtime. Oximetry data will be obtained using the same Nonin oximeter. These post-operative measurements will be performed in addition to standard ward monitoring. Patient's will wear the Nonin WristOx 3150 for 48 continuous hours and it will be connected to the patient once they reach the post operative ward or ICU.
Locations(2)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12623000405617