Use of Rainbow Acoustic Monitoring in Pediatric Patients - a Clinical Engineering Data Collection Protocol
The data will be collected in the Post Anesthesia Care Unit (PACU) and followed up to the general surgery floor (GF) or PICU.
Patients that are 0-18 years old, under general anesthesia and expected to be hospitalized postoperatively will be included in the study. Following routine induction of anesthesia, between 1 and 3 prototype Acoustical Respiratory Rate Monitor adhesive sensors will be applied. Manufacturer recommends placing the sensor on the lateral aspect of the patient[Right Quote]s neck anterior to the sternocleidomastoid muscle in an oblique way. Depending on the size and comfort of the child, the sensor(s) may also be placed on the chest along the sternum, inferior to the right clavicle, or along the right mid-axillary chest, and/or the abdomen.The adhesive of the RAM sensor is similar to the adhesive on a pulse oximeter probe. The RAM sensor(s) as well as an oxygen saturation (SpO2) sensor for each RAM sensor are connected to a Dual Rainbow Cable and then to the Rad87 that will continuously record the respiratory rate and store data onto a laptop. Additionally, the respiration rate will be recorded using a standard intraoperative capnography device.
At the conclusion of the surgery and anesthesia, sidestream capnography device connected to a nasal cannula (CapnoStream20tm , Oridion, Jerusalem, Israel) and impedance pneumography connected to ECG pads (Intellivue MP2, Philips Inc.) will be applied to the child in addition to prototype pediatric RAM sensor and SpO2 probe mentioned above. All three monitors will be connected to the laptop and recording will continue until the next morning through the PACU period and then either PICU or floor. In addition, the respiration rate will also be recorded manually. At the request of the parents, or in case the patient would be uncomfortable with the nasal cannula or the RAM probe, data collection will be stopped and subject will be withdrawn from the study.
Between one and three single-patient use prototype adhesive RAM sensor will be placed on either side of the neck and/or chest and connected to a bedside monitor to continuously display and alarm on respiratory rate. The sensor for the study will be marked, [Double Quote]Clinical Use Only[Double Quote]. Patients will be screened, consented and enrolled preoperatively according to the following inclusion and exclusion criteria.
Sample size of patients: a total of up to 200 patients will be included in the study.
•0-18 years old inclusive, male and female patients
•Only patients with written informed consent signed by parents or legal guardians will be enrolled
•In children 10 and older patient’s assent will be obtained