Vital sign monitoring with continuous pulse oximetry and wireless clinical notification after surgery (the VIGILANCE pilot study)-a randomized controlled pilot trial

James E Paul, Matthew A Chong, Norman Buckley, Prathiba Harsha, Harsha Shanthanna, Antonella Tidy, Diane Buckley, Anne Clarke, Christopher Young, Timothy Wong, Thuvaraha Vanniyasingam, Lehana Thabane, James E Paul, Matthew A Chong, Norman Buckley, Prathiba Harsha, Harsha Shanthanna, Antonella Tidy, Diane Buckley, Anne Clarke, Christopher Young, Timothy Wong, Thuvaraha Vanniyasingam, Lehana Thabane

Abstract

Background: Respiratory depression is a serious perioperative complication associated with morbidity and mortality. Recently, technology has become available to wirelessly monitor patients on regular surgical wards with continuous pulse oximetry and wireless clinician notification with alarms. When a patient's SpO2 falls below a set threshold, the clinician is notified via a pager and may intervene earlier to prevent further clinical deterioration. To date, the technology has not been evaluated with a randomized controlled trial (RCT).

Methods: We designed a parallel-group unblinded pilot RCT of a wireless monitoring system on two surgical wards in an academic teaching hospital. Postsurgical patients with an anticipated length of stay of at least 1 day were included and randomized to standard care or standard care plus wireless respiratory monitoring for up to a 72-h period. The primary outcomes were feasibility outcomes: average patients recruited per week and tolerability of the system by patients. Secondary outcomes included (1) respiratory events (naloxone administration for respiratory depression, ICU transfers, and cardiac arrest team activation) and (2) system alarm types and details. The analysis of the outcomes was based on descriptive statistics and estimates reported using point (95% confidence intervals). Criteria for success of feasibility were recruitment of an average of 15 patients/week and 90% of the patients tolerating the system.

Results: The pilot trial enrolled 250 of the 335 patients screened for eligibility, with 126 and 124 patients entering the standard monitoring and wireless groups, respectively. Baseline demographics were similar between groups, except for slightly more women in the wireless group. Average patient recruitment per week was 14 95% CI [12, 16] patients. The wireless monitoring was quite tolerable with 86.6% (95% CI 78.2-92.7%) of patients completing the full course, and there were no other adverse events directly attributable to the monitoring. With regard to secondary outcomes, the respiratory event rate was low with only 1 event in the wireless group and none in the control group. The average number of alarms per week was 4.0 (95% CI, 1.6-6.4).

Conclusions: This pilot study demonstrated adequate patient recruitment and high tolerability of the wireless monitoring system. A full RCT that is powered to detect patient important outcomes such as respiratory depression is now underway.

Trial registration: ClinicalTrials.gov, Registration number NCT02907255, registered 7 September 2016-retrospectively registered.

Keywords: Pilot trial or study; Respiratory depression; Wireless respiratory monitoring.

Conflict of interest statement

JP is the Chair of the Department of Anesthesia and Acute Pain Service Director of McMaster University’s Department of Anesthesia.Ethics approval was acquired prior to commencement of the trial from the Hamilton Health Sciences Research Ethics Board.Not applicable.The authors declare that they have no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

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CONSORT Flowsheet

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