Here is the design of a clinical trial:

Official Title: Effect of Endotracheal Tube Plus STYLET Versus Endotracheal Tube Alone on Successful First-Pass Orotracheal Intubation Among Critically Ill Patients: the Randomised STYLETO Study Protocol"

Included conditions:
- Intubation Complication
- Critically Ill

Study Armgroups:
- {'label': 'ENDOTRACHEAL TUBE + STYLET', 'type': 'EXPERIMENTAL', 'description': 'The experimental group consists in intubating the trachea with an endotracheal tube + stylet with a "straight-to-cuff" shape and a bend angle of 25° to 35°.', 'interventionNames': ['Device: ENDOTRACHEAL TUBE + STYLET']}
- {'label': 'ENDOTRACHEAL TUBE ALONE', 'type': 'ACTIVE_COMPARATOR', 'description': 'The control group consists in intubating the trachea with an endotracheal tube alone (i.e, without stylet).', 'interventionNames': ['Device: ENDOTRACHEAL TUBE ALONE']}

Interventions:
- {'type': 'DEVICE', 'name': 'ENDOTRACHEAL TUBE + STYLET', 'description': 'The experimental group consists in intubating the trachea with an endotracheal tube + stylet with a "straight-to-cuff" shape and a bend angle of 25° to 35°', 'armGroupLabels': ['ENDOTRACHEAL TUBE + STYLET']}
- {'type': 'DEVICE', 'name': 'ENDOTRACHEAL TUBE ALONE', 'description': 'intubating the trachea with an endotracheal tube alone', 'armGroupLabels': ['ENDOTRACHEAL TUBE ALONE']}

Primary Outcomes:
- {'measure': 'Number of patients with successful first-pass orotracheal intubation', 'description': 'the proportion of patients with successful first-pass orotracheal intubation', 'timeFrame': 'At intubation'}

Please estimate the sample size based on the assumption: 
two-sided α level of 0.05, statistical power of 95%, and considerations for withdrawn consent, inclusions not meeting criteria, or improvement/death before intubation
Sample size
        The primary outcome is the first-attempt success during intubation procedure. For this study, 2Ã485 patients are needed to detect a 10% difference in the first-attempt success rate during intubation procedure (from 70% without stylet to 80% with stylet, difference judged clinically important,2 10 at a two-sided Î± level of 0.05 and a statistical power of 95%).4 27 28 To take into account withdrawn consent after randomisation, inclusions not meeting the inclusion criteria or improvement or death before intubation, 1040 patients will be included: 520 patients in each group.