Here is the design of a clinical trial:

Official Title: Comparison of an Inhaled Sedation Strategy to an Intravenous Sedation Strategy in Intensive Care Unit Patients Treated With Invasive Mechanical Ventilation : INASED Study

Included conditions:
- Prevention of Delirium

Study Armgroups:
- {'label': 'Usual sedation', 'type': 'ACTIVE_COMPARATOR', 'description': 'Sedation according to a written, standardized Nurse management protocol using at least one sedative drug (propofol) and one analgesic drug.', 'interventionNames': ['Drug: Propofol + analgesic drug']}
- {'label': 'Inhaled sedation', 'type': 'EXPERIMENTAL', 'description': 'Sedation by inhalation of halogenated gas (Isoflurane) delivered by the Anesthetic-Conserving Device (ACD) system ANACONDA ™ associated with the administration of an analgesic drug.', 'interventionNames': ['Drug: Isoflurane + analgesic drug']}

Interventions:
- {'type': 'DRUG', 'name': 'Propofol + analgesic drug', 'description': 'sedation according to a written, standardized Nurse management protocol using at least one sedative drug (propofol) and one analgesic drug. It uses the nurse driven analgesia protocol of each ward involved in the study. It uses a pain assessment score (BPS, VICOMORE, FLACC), local or regional anesthesia, non-opioïd adjuncts (acetaminophen, NSAIDs, nefopam), opioïds (per os opioïds, bolus of sufentanyl followed by continuous infusion if necessary, continuous infusion of remifentanyl', 'armGroupLabels': ['Usual sedation']}
- {'type': 'DRUG', 'name': 'Isoflurane + analgesic drug', 'description': 'sedation by inhalation of halogenated gas (Isoflurane) delivered by the Anesthetic-Conserving Device (ACD) system ANACONDA ™ associated with the administration of a analgesic drug. It uses the nurse driven analgesia protocol of each ward involved in the study. It uses a pain assessment score (BPS, VICOMORE, FLACC), local or regional anesthesia, non-opioïd adjuncts (acetaminophen, NSAIDs, nefopam), opioïds (per os opioïds, bolus of sufentanyl followed by continuous infusion if necessary, continuous infusion of remifentanyl.', 'armGroupLabels': ['Inhaled sedation']}

Primary Outcomes:
- {'measure': 'Occurrence of a delirium in intensive care', 'description': 'Occurrence of delirium in intensive care will be observed (yes / no)', 'timeFrame': '28 days'}

Please estimate the sample size based on the assumption: 
Power of 80%, two-sided alpha level of 0.05, 3% lost to follow-up.
Sample size
        We determined that enrolment of 250 patients would provide a power of 80% to show a reduction by half (30% vs 15%) in the rate of delirium occurrence between the control group using intravenous sedation and the interventional group using inhaled sedation at a two-sided alpha level of 0.05, accounting for 3% lost to follow-up.
        
          Recruitment
        
        The initial duration of patient enrolment expected is 2 years, starting in July 2020. The 2020: approval by an independent Ethics Committee; 2020â2022: recruitment period; 2022: end of recruitment, monitoring of participating centres and queries to investigators; blind review to determine protocol violation, to define intention-to-treat and per-protocol analysis populations; new queries to investigators, cleaning and closure of the database; 2023: data analysis, writing of the manuscript and submission for publication.