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Challenges and Pitfalls With a Randomized Clinical Trial in the Postanesthesia Care Unit

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By: , & Published: 2020 | Product: SAGE Research Methods Cases: Medicine and Health
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Abstract

Breathing disturbances after surgery are relatively common and are often the result of patient-related factors, anesthesia-related factors, or both. These disturbances are mainly associated with opioid treatment and can result in a shortage of oxygen and/or an excess of carbon dioxide. If patient monitoring is inadequate, changes in breathing can potentially be deadly. Patients after surgery therefore require intensive monitoring of heart rate and breathing patterns. We performed a randomized clinical trial to study a new, smart monitor that enables assessment of respiratory function in postoperative patients. This monitor gives an Integrated Pulmonary Index (IPI™) value ranging from 1 to 10 based on the respiratory condition of the patient. Half of the 80 included patients were randomized to receive the IPI™ monitor directly after surgery until the first postoperative morning, but values were not considered for clinical decision-making (observational arm). The other half of the patients were randomized to receive the IPI™ monitor, and interventions of the caregivers were initiated when the IPI™ values were low. The study was completed within a year without big problems. We learned that we needed to empathize with all involved stakeholders to successfully complete the study. This included the set-up of clinical lessons and practicing with a dummy monitor, to allow all caregivers to be informed on the goal, set-up, and execution practicalities of the study.

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