Postoperative respiratory depression Breathing problems after surgery
Conditions
Interventions
The products under investigation are two CE-marked wearable respiratory monitoring systems intended for continuous monitoring of respiratory rate in hospitalized patients:The GE HealthCare Portrait™ M
The Masimo Radius VSM™ system configured for respiratory rate monitoring.The GEHC Portrait™ Mobile system utilizes a dual-vector thoracic impedance-based approach to estimate respiratory activity thro
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Participants are eligible for inclusion if they meet all of the following criteria:Patients aged 18 years and older, of any gender;Postoperative patients following elective surgery;ASA 1-3 patients;Undergoing a procedure under general anesthesia;Received opioids for postoperative pain.
Exclusion criteria
Exclusion criteria: Participants will be excluded from participation if one or more of the following criteria apply:Requirement for transfer to the Intensive Care Unit (ICU) or Medium Care Unit;Undergoing cardiac or pulmonary surgery;Presence of a thoracolumbar drain, due to potential interference with impedance measurements;Respiratory insufficiency requiring reintubation;Surgical complications requiring emergency surgery;Presence of atrial or ventricular arrhythmias, or dysrhythmias other than premature atrial contractions (PACs) or premature ventricular contractions (PVCs) on the baseline ECG.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of the study is the evaluation and comparison of the capability and reliability of the GE HealthCare Portrait™ Mobile system and the Masimo Radius VSM™ system to detect clinically relevant respiratory insufficiency in postoperative patients at increased risk of respiratory decompensation on the hospital ward.Primary study parameters include:Continuous respiratory rate measurements obtained from both monitoring systems;Characterization of respiratory rate trends and respiratory patterns over time;Detection of respiratory abnormalities, including hypoventilation, hyperventilation, apnea, and periodic breathing patterns such as Cheyne–Stokes respiration;Correlation of device-derived respiratory findings with clinically observed and documented respiratory insufficiency events identified and treated by bedside clinicians during routine care.Respiratory pattern characterization may involve clinical expert interpretation, signal-processing methodologies, and exploratory artificial intelligence (AI)-based analytical approaches.Secondary outcome measures include:Evaluation of usability and integration of both monitoring systems into routine postoperative ward workflows;Assessment of the feasibility of prolonged wearable respiratory monitoring in ambulatory postoperative patients;Exploratory assessment of the potential impact of continuous respiratory monitoring on the recognition and management of postoperative respiratory complications and clinical deterioration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study outcomes include the evaluation of usability, feasibility, and clinical integration of the GE HealthCare Portrait™ Mobile and Masimo Radius VSM™ monitoring systems during routine postoperative ward care.Secondary study parameters include:Usability of both monitoring systems for patients and healthcare personnel;Integration of the monitoring systems into routine clinical workflows on the postoperative ward;Feasibility and tolerability of prolonged continuous wearable respiratory monitoring in ambulatory postoperative patients;Frequency and nature of technical issues, signal interruptions, or monitoring artifacts encountered during clinical use;Exploratory assessment of the potential contribution of continuous respiratory monitoring to earlier recognition of postoperative respiratory complications and clinical deterioration.Additional exploratory analyses may evaluate respiratory pattern characteristics using clinical expert review, signal-processing techniques, and artificial intelligence (AI)-based analytical methods. | — |
Countries
Netherlands
Contacts
Public ContactR.M. van der Schrier
Leids Universitair Medisch Centrum
Outcome results
None listed