None listed
Conditions
Brief summary
Paediatric patients undergoing cardiac surgery or inpatient in the intensive care unit at the Royal Children’s Hospital in Melbourne (RCH) will have a study pulse oximeter (Contec Pulse Oximeter, model CMS50DL) placed on a digit when an arterial blood gas is being drawn for routine clinical management. At this time, the patient’s vital signs and specific values from the arterial blood gas measurements will be recorded and, ultimately, the usual RCH pulse oximetry readings and arterial blood gas co-oximetry values will be compared with study pulse oximeter readings. All paediatric patients undergoing cardiac surgery at RCH during the specified time period will be eligible and may be subjects in this study. Patients and/or the patient’s legally acceptable representative will be provided with a study information sheet. Verbal consent will be obtained for all patients. Patients and/or the patient’s legally acceptable representative will also be asked to fill out a survey as part of the study. Study hypothesis: We are conducting this study to test whether a low-priced pulse oximeter (a medical device to measure the amount of oxygen in the blood) is accurate in paediatric patients, particularly those undergoing cardiac surgery.
Interventions
Intraoperatively, the patients will be monitored as per usual anaesthetic standards, including heart rate, blood pressure, temperature, and pulse oximetry. When the anaesthetic team deems it time to draw a baseline arterial blood gas, per routine clinical management of the patient, the study pulse oximeter (Contec Pulse Oximeter, model CMS50DL) will be placed on one of the patient’s digits. Attempts will be made to place the study pulse oximeter on the same limb as the arterial line, if patient
Intraoperatively, the patients will be monitored as per usual anaesthetic standards, including heart rate, blood pressure, temperature, and pulse oximetry. When the anaesthetic team deems it time to draw a baseline arterial blood gas, per routine clinical management of the patient, the study pulse oximeter (Contec Pulse Oximeter, model CMS50DL) will be placed on one of the patient’s digits. Attempts will be made to place the study pulse oximeter on the same limb as the arterial line, if patient body size allows and particularly if a patent ductus arteriosus exists. Moreover, the study pulse oximeter will be placed on the same limb as the standard pulse oximeter, pending a patient’s body size. The oximeter reading will be allowed to reach a plateau, which will be defined as the consistent reading fifteen seconds after being placed on the patient. After obtaining said plateau after fifteen seconds, the arterial blood gas will be drawn and the patient’s SpO2 from the standard pulse oximeter, heart rate from the standard pulse oximeter or electrocardiogram tracing, SpO2 and heart rate from the study pulse oximeter, arterial blood pressure, oesophageal or nasopharyngeal temperature, skin temperature near the site of oximetry, arterial blood gas haemoglobin, and arterial blood gas co-oximetry values will be recorded and used for comparison. Notably, if unable to place both oximeters on the same limb because of small patient body size, the aforementioned standard RCH pulse oximeter will be the pulse oximeter located in a similar location as to the study pulse oximeter with regards to a patent ductus arteriosus or coarctation of the aorta. It is anticipated that the duration of participation should be approximately five minutes per sample, allowing for placement of study pulse oximeter, waiting for the fifteen second plateau, and recording of the values previously mentioned. Participants or their caregivers will also be asked to complete a demographic/characteristic survey. Skin type will also be assessed by using the Fitzpatrick scale.
Sponsors
The Royal Children's Hospital Melbourne
Eligibility
Sex/Gender
All
Age
1 Days to 17 Years
Healthy volunteers
No
Inclusion criteria
• Under the age of eighteen years old • Undergoing cardiac surgery requiring placement of an arterial line for routine clinical care at RCH or are in the intensive care unit at RCH with an arterial line for routine clinical management • Has a legally acceptable representative capable of understanding the study information sheet and providing verbal consent on the participant’s behalf • Completes the patient demographic/characteristic survey or has a legally acceptable representative capable of understanding the survey who completes it on the participant’s behalf
Exclusion criteria
• Is classified as not having pulsatile peripheral flow, as in the setting of a ventricular assist device Participants may also be excluded if they have previously participated in this study, pending enrolment numbers.
Outcome results
None listed