WARD Surgical RCT

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WARD Surgical Randomized Clinical Trial (RCT)

 

Study design:

Randomized Clinical Trial

 

Sample size

400 participants

 

Study Sites

Rigshospitalet, Bispebjerg Hospital, Odense University Hospital, Aarhus University Hospital.

 

Inclusion criteria

Adult patients (from 18 years of age) undergoing major abdominal-, orthopedic-, urological- or vascular surgery.

 

Study Procedures

Camilla Lundgreen Duus, MD Included patients were monitored with WARD equipment after surgery, applied in the post-anesthesia care unit (PACU) and up to 5 days postoperatively while hospitalized. 200 patients are randomized to receive standard treatment in the hospital ward (control group), where WARD study-data are blinded to the healthcare professionals (nurses etc.) treating the patient. The remaining 200 patients (case group) will have real-time continuous vital parameter data transferred to an alarm-generating App (WARD CSS) in case of vital parameter deviations, that the nurse responsible for the patient can access through a provided WARD smartphone. 

Outcome

The primary outcome is the amount and duration of physiological parameter deviations between the two groups. Secondary outcome is the number of postoperative complications within 30 days after surgery between the two groups. 

Primary Investigators

Camilla Haahr-Raunkjær, MD, PhD student

Jesper Mølgaard, MD, PhD student

NCT:

NCT04640415