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Table 1 Schedule for study interventions according to Recommendations for Interventional Trials (SPIRIT) indications

From: Nasal high-flow compared to non-invasive ventilation in treatment of acute acidotic hypercapnic exacerbation of chronic obstructive pulmonary disease—protocol for a randomized controlled noninferiority trial (ELVIS)

Examination/assessment   Treatment Follow-up
  Screening Visit 0 Visit 1 Visit 2 Visit 3   Visit 4 Visit 5a Visit 6a
Timepoint   0 h 1 h
± 30 min
2 h
± 30 min
4 h
± 30 min
6 h
± 30 min
12 h
± 60 min
24 h
± 60 min
36 h
± 90 min
48 h
± 120 min
72 h
± 180 min
discharge day 7b
± 1 day
day 28 day 90
Informed consent Xc            Xd    
Inclusion criteria/exclusion criteria X               
Randomization   X              
Patient characteristics (anamnesis, comorbidity) X               
Medication X        Xe   Xe Xe X    
Clinical parameters (heart rate, respiratory rate, blood pressure, Borg’s scale) X   X X X X X X X X X X X   
Adverse events/side-effects    X X X X X X X X X X X X X
Glasgow coma scale (GCS) X   X X X X X X X X X X    
Blood gas analysis (BGA): pO2, pCO2, pH, SpO2, FIO2 X   X X X X X X X X X X X   
Therapy according to allocated device: device parameters   X X6 X X X X X X X X X Xg Xf Xf
Therapy: oxygen supplement   X X X X X X X X X X X Xf Xf Xf
infection parameters and biomarkers (optional) X        Xe    Xe     
  1. aVisits 5 and 6 are conducted by telephone
  2. bAssessment of intubation; not applicable, if patient is already discharged since no intubation can be stated in this care
  3. cStandard (long) version of informed consent OR concise (short) version of informed consent
  4. dStandard (long) version of informed consent, if patient is still able to give informed consent
  5. eAll medications within the last 24 h resp. laboratory parameters any time within the last 24 h
  6. fA change of device is possible, if switch criteria are fulfilled OR need for intubation criteria are met before 72 h → primary endpoint reached
  7. gOngoing treatment, if patient still hospitalized