The goal of this observational study is to learn if a chest monitor that tracks heart rhythm can help predict whether adults on a breathing machine after surgery will be able to breathe on their own once the breathing tube is removed. It is being done in adults recovering from surgery in the intensive care unit (ICU).
The main questions it aims to answer are:
Can heart rhythm patterns, measured soon after ICU admission and during a breathing test, show whether a patient is likely to breathe well without the machine? Do these patterns change in a helpful way when the breathing tube is removed?
Participants will:
Have soft, sticky patches placed on their chest, similar to those used for a regular heart monitor Have their heart rhythm recorded for 5 minutes at four times: soon after ICU admission, before a breathing test, during the breathing test, and right after the breathing tube is removed Continue to receive their usual ICU care; doctors will not see the monitor's readings, so these readings will not affect any treatment decisions
Age 18 years or older
Admitted to the surgical intensive care unit (ICU) after surgery
Currently on a breathing machine (mechanical ventilation) through a tube in the airway
Receiving dexmedetomidine as the main sedative medication, with a stable, predefined level of sedation
Permanent irregular heart rhythm (atrial fibrillation or atrial flutter)
Complete heart block or a heart rhythm that is fully controlled by a pacemaker
Already has a tracheostomy (a breathing tube placed through the neck)
A decision has already been made at ICU admission to withhold or withdraw life-sustaining treatment
Participants are drawn from adult patients admitted to the surgical intensive care unit (ICU) of Seoul Metropolitan Government Seoul National University Boramae Medical Center, a public academic hospital in Seoul, South Korea, following surgery. The surgical ICU cares for postoperative patients across multiple surgical specialties, including general surgery, thoracic and cardiovascular surgery, and other surgical disciplines requiring postoperative critical care. Eligible participants are identified from among those requiring invasive mechanical ventilation after surgery and sedated according to standard ICU sedation practice at this institution.
Cohort
Prospective
Not listed
proportion of participants with successful extubation
A participant's breathing tube is removed (extubated) after a period of mechanical ventilation, following a trial in which the ventilator support is reduced to see if the participant can breathe adequately on their own (a spontaneous breathing trial). Extubation is considered successful if the participant does not need the breathing tube reinserted within 48 hours. If a participant dies within this 48-hour window without having the breathing tube reinserted, this is not counted as a failed extubation and is recorded as a separate outcome. This outcome will be analyzed in relation to heart rate variability measurements (an indicator of autonomic nervous system activity, obtained non-invasively from a chest monitor) taken at the time of intensive care unit admission, before the breathing trial, and during the breathing trial.
Proportion of Participants with Reintubation Following Post-Extubation ANI Measurement
Reintubation is defined as reinsertion of a breathing tube within 48 hours after extubation. This outcome will be analyzed in relation to heart rate variability values measured by a chest monitor immediately after extubation, to explore whether values recorded right after the breathing tube is removed are associated with the need to reinsert it.
Proportion of Participants with Successful Extubation, by Change in Heart Rate Variability During the Breathing Trial
The change in heart rate variability value (a measure of autonomic nervous system activity obtained from a chest monitor) between the measurement taken just before the breathing trial and the measurement taken during the breathing trial will be calculated for each participant. Successful extubation is defined as no reinsertion of the breathing tube within 48 hours after extubation. This outcome will be analyzed according to the magnitude of change in heart rate variability
Length of Stay in the Intensive Care Unit and Hospital
Length of stay is defined as the number of days from intensive care unit (ICU) admission to ICU discharge, and from hospital admission to hospital discharge, respectively.
Proportion of Participants who Died in the Intensive Care Unit, in the Hospital, or Within 28 Days
Death occurring during the intensive care unit (ICU) stay, during the hospital stay, and within 28 days of study enrollment will each be recorded separately as three distinct measures of mortality.
Click on the lead sponsor to view all of their trials.
Seoul National University Hospital
Lead sponsor
SMG-SNU Boramae Medical Center
Collaborator
