Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 0C1, Canada
NCT Number: NCT05686109
The objective of this ancillary study of the MEET-OS study is to assess the technical feasibility of using Biobeat® monitoring devices after ambulatory surgery at high risk of complications.
The secondary objectives are to assess: i) the patient's experience and tolerance ii) the occurrence of clinical disturbances in the patients's home after ambulatory surgery with high risk of postoperative complications iii) to determine the impact of the data obtained with the monitoring devices on the clinical care decisions during postoperative follow-up.
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Notify Me18 year and older
All sexes
Observational
Montreal, Quebec, H2X 0C1, Canada
With increasingly complex surgeries and increasingly comorbid patients, ambulatory surgery are not always at low risk of postoperative complications. Among the new support tools available for monitoring patients remotely, devices for monitoring vital signs could be of interest to healthcare staff in charge of monitoring, more precisely when comorbid patients are involved or when interventions at high risk of complications are performed.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: From the installation of the monitoring device after the surgery up to 5 days postoperatively.
Time frame: From the installation of the monitoring device after the surgery up to 5 days postoperatively.
Time frame: From the installation of the monitoring device after the surgery up to 5 days postoperatively.
Time frame: From the installation of the monitoring device after the surgery up to 5 days postoperatively.
The postoperative event is defined as a call to the CHUM health info line.
Time frame: From the installation of the monitoring device after the surgery up to 5 days postoperatively.
The occurrence of manufacturer alerts and the following clinical disturbances within 72 hours postoperatively will be evaluated: moderate postoperative arterial hypotension (defined by mean arterial pressure < 65 mmHg), severe arterial hypotension defined by MAP < 60 mmHg; moderate arterial hypertension defined by an MAP > 110mmHg; severe arterial hypertension defined by a MAP > 130mmHg; bradycardia defined by a heart rate < 40bpm; tachycardia defined by a heart rate > 100bpm; bradypnea defined by respiratory rate < 8/min; tachypnea defined by respiratory rate > 20/min; oxygen desaturation < 95%; oxygen desaturation < 90%; oxygen desaturation < 85%; hypothermia defined as body temperature < 36.0°C; hyperthermia defined as body temperature > 38.0°C.
Time frame: 7 days after the surgery
A phone interview will be conducted to collect the patient's experience with a questionnaire derived from Breteler and al., which consist of 12 questions, adapted to the present study and focused on the experience of the patient and his caregiver, his tolerance and his satisfaction.
Time frame: Up to 60 days after surgery
Centre hospitalier de l'Université de Montréal (CHUM)
Other
Ancillary Study: Monitoring of Patients After Ambulatory Surgery by Biobeat® Devices: Pilot Feasibility Study
Acronym: BIOBEAT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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