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Table 1 Study evaluations

From: The Hip Fracture Surgery in Elderly Patients (HIPELD) study: protocol for a randomized, multicenter controlled trial evaluating the effect of xenon on postoperative delirium in older patients undergoing hip fracture surgery

  Visit 0a(selection) Visit 1b (GA) Visit 2a(3 h post GA) Visit 3a(day 1) Visit 4a (day 2) Visit 5a (day 3) Visit 6a (day 4) Visit 7a (day 5 to D) Visit 8a (study end)
     A B A B A B A B A B  
Signed informed consent X              
Selection criteria X              
Demographic data X              
Vital signs X X X X   X   X   X   X   
Medical and surgical history X              
Concomitant diseases X              
Concomitant medication X X X X X X X X X X X X X X
MMSE evaluation X              
Randomization    X            
General anesthesia    X            
Blood sample X    X   X   X   X   According to investigator’s judgment  
CAM evaluation X   X X X X X X X X X X X  
Pain VAS evaluation X X X X   X   X   X     
Verbal Rating Scale for Nausea   X X X           
SOFA X    X X X X According to investigator’s judgment  
Recovery parameters   X             
Adverse events   X X X X X X X X X X X X X
  1. A represents 10:00 am ± 30 minutes; B represents 6:00 pm ± 30 minutes; day 5 to D is post-surgery day 5 until discharge from hospital (or at maximum 28 days post surgery), or withdrawal from the study.
  2. aPhysician 1; bPhysician 2.
  3. CAM = Confusion Assessment Method; GA = general anesthesia; MMSE = Mini-Mental State Examination; SOFA = Sequential Organ Failure Assessment; VAS = visual analog scale.