Safety of moderate-to-deep sedation performed by sedation practitioners: A national prospective observational study

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Abstract

BACKGROUND

In the Netherlands, a significant proportion of moderate-to-deep sedation is performed by sedation practitioners under the indirect supervision of an anaesthesiologist but there are limited safety data available.

OBJECTIVE

To estimate the rate of sedation-related adverse events and patient relevant outcomes (PRO).

DESIGN

This was a prospective national observational study. Data were collected with a modified adverse event reporting tool from the International Sedation Task Force of the World Society of Intravenous Anaesthesia.

SETTING

A total of 24 hospitals in the Netherlands where moderate-to-deep sedation was performed by sedation practitioners from the 1 February 2015 to 1 March 2016.

PATIENTS

Consecutive adults undergoing moderate-to-deep sedation for gastrointestinal, pulmonary and cardiac procedures.

INTERVENTION

Observation: Analysis included descriptive statistics and a multivariate logistic regression model for an association between adverse events and PRO.

MAIN OUTCOME MEASURES

The primary outcome was the rate of unfavourable PRO (admission to ICU, permanent neurological deficit, pulmonary aspiration or death). Secondary outcome was the rate of moderate-to-good PRO (unplanned hospital admission or escalation of care). Composite outcome was the sum of all primary and secondary outcomes.

RESULTS

A total of 11 869 patients with a median age of 64 years [interquartile range 51 to 72] were included. ASA physical score distribution was: first, 19.1%; second, 57.6%; third, 21.6%; fourth, 1.2%. Minimal adverse events occurred in 1517 (12.8%), minor adverse events in 113 (1.0%) and major adverse events in 80 instances (0.7%). Primary outcome: Five (0.04%) unfavourable PRO were observed; four patients needing admission to the intensive care unit; and one died. Secondary outcome: 12 (0.1%) moderate-to-good PRO were observed. Moderate and major adverse events were associated with the composite outcome [3.7 (95% confidence interval 1.1 to 11.9) and 40.6 (95% confidence interval 11.0 to 150.4)], but not minimal or minor adverse events.

CONCLUSION

Moderate-to-deep sedation performed by trained sedation practitioners has a very low rate of unfavourable outcome.

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