A longitudinal pilot study assessing the medical and surgical treatment of babies with congenital upper airway conditions.
Prospective Longitudinal Assessment of Treatment options for Young Patients with Upper airway Structural abnormalities (PLATYPUS): a pilot study
Perth Children's Hospital
120 participants
Apr 19, 2024
Interventional
Conditions
Summary
Laryngomalacia is the most common congenital airway abnormality in young children. In the most severe cases, surgical intervention is necessary to prevent serious complications from arising and to allow for the normal development of breathing and feeding. Supraglottoplasty is the most common surgical procedure employed to address severe laryngomalacia. The procedure reduces or stabilises the problematic laryngeal tissue preventing further obstruction from occurring. Existing literature on the efficacy of this surgery has demonstrated that this procedure is not always effective at resolving symptoms. The factors that contribute to the success or failure of supraglottoplasty have been difficult to elucidate but are likely closely related to the patient’s pre-operative clinical condition. We propose a prospective study investigating the use of continuous pre-operative pulse oximetry as a tool to better understand the nature of the laryngomalacia present and identify patients most likely to benefit from supraglottoplasty surgery.
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Interventions
Infants with symptoms of laryngomalacia will be recruited through the Ear, Nose and Throat (ENT) service. Participants will be divided into two groups according to their clinical presentation and the judgement of the treating ENT consultant in line with the current clinical guidelines and routine clinical practice of the ENT service. There will be no changes in the management or any aspect of clinical care due to trial participation. Planned surgical management group: Patients who are planned for diagnostic laryngotracheobronchoscopy (LTB) +/- supraglottoplasty for the treatment of suspected laryngomalacia. Supraglottoplasty will be defined as any surgical procedure done to stabilise the tissue of the supraglottic larynx. Medical management group: Patients with suspected laryngomalacia who are for conservative non-surgical treatment after ENT appointment. Patients born premature (before 36 weeks gestation) will have their ages corrected to 40 weeks. Patients born at term will be referred to by their birth age. Enrolled patients will undergo oximetry monitoring using a Nonin oximeter device (WristOx 3150, Nonin Medical, Plymouth, MN, United States). The Nonin WristOx 3150 is a small, lightweight pulse oximeter ideal for use in the patient’s home and has probes that are designed for use with paediatric patients. It is easy to use as it is activated when the probe is placed on the patients foot or toe. The monitor can be attached easily to the patient's crib. Patients will wear the oximeter continuously for 48 hours following their initial consultation with the Perth Children’s Hospital ENT team. The medical management group will do 48 hours of Nonin WristOx monitoring following their regular scheduled ENT appointment at 3 months age/3 months corrected age, as well as each subsequent ENT clinic appointment until they reach 6 months of age/6 months corrected age if premature, or they are discharged from the ENT surgical clinic, whichever occurs first. After each round of oximetry recordings, the data will be downloaded using Nonin nVision software to assess the length of time for which the device was worn and the quality of the recording (e.g., artefact burden). Patients in the surgical management group will undergo oximetry monitoring using the Nonin WristOx 3150 and transcutaneous carbon dioxide monitoring using the SenTec digital monitoring system (SenTec, Lincoln, RI, United States) at the time of their surgery. Patients who are inpatients prior to their surgery will also have Sentec monitoring for 1 night pre operatively. SenTec monitoring involves a probe on the patient’s skin, usually on the forehead or shoulder. Following SenTec monitoring, the data will be downloaded and assessed by a trained researcher to establish the length of time for which the device was worn and the quality of the recording. Patients will undergo oximetry again 8 weeks following their supraglottoplasty procedure. For most patients, this will occur at approximately 3 months of age/3 months corrected age, in line with the oximetry done for the medical management group. Patients in the surgical management group will repeat oximetry at each subsequent appointment until they reach 6 months of age/6 months corrected age, or until they are discharged from the ENT surgical clinic, whichever occurs first. As per routine care, these appointments can be in person, via telehealth or over the phone. If the appointment is not in person, the oximeter will be posted to the families.
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ACTRN12624000007538