BMJ open · 2026
Rapid sequence induction versus standard induction in patients with moderate aspiration risk: study protocol for a multicentre randomised controlled trial (INCORRECT trial).
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Krug Natalie, Caspar Florian, Petroff David, Pietsch Uta-Carolin, Gottschaldt Udo, Reske Andreas Wolfgang, Ullmann Hannah, Bercker Sven
Аннотация
INTRODUCTION: Rapid sequence induction (RSI) is widely used in patients at risk of pulmonary aspiration but may be associated with haemodynamic instability and intubation difficulties. It remains unclear whether patients with moderately increased risk of aspiration benefit from RSI compared with standard induction including mask ventilation.
METHODS AND ANALYSIS: This multicentre, randomised, controlled, parallel-group, patient-blinded trial will enrol 792 adult surgical patients with moderately increased risk of aspiration. Participants will be randomised 1:1 to RSI (no mask ventilation, rocuronium 1.0-1.2 mg/kg) or standard induction (mask ventilation with rocuronium 0.5-0.6 mg/kg until adequate neuromuscular blockade before intubation). The primary outcome is clinically relevant hypotension within 15 min after induction (peri-induction period), defined as mean arterial pressure <65 mm Hg for >1 min, a decrease >20% from baseline or vasopressor administration. Secondary outcomes include oxygen desaturation, pulmonary aspiration, intubation difficulty (first-pass success and Cormack-Lehane grade), residual neuromuscular blockade and postoperative sore throat. Recruitment is planned over approximately 3 years and is ongoing. All analyses will follow the intention-to-treat principle.
ETHICS AND DISSEMINATION: The study has been approved by the Ethics Committee of the Medical Faculty, University of Leipzig, Germany (reference number: 193/23-ek). Results will be disseminated through peer-reviewed publications and presented at scientific conferences.
TRIAL REGISTRATION NUMBER: DRKS00031940.
METHODS AND ANALYSIS: This multicentre, randomised, controlled, parallel-group, patient-blinded trial will enrol 792 adult surgical patients with moderately increased risk of aspiration. Participants will be randomised 1:1 to RSI (no mask ventilation, rocuronium 1.0-1.2 mg/kg) or standard induction (mask ventilation with rocuronium 0.5-0.6 mg/kg until adequate neuromuscular blockade before intubation). The primary outcome is clinically relevant hypotension within 15 min after induction (peri-induction period), defined as mean arterial pressure <65 mm Hg for >1 min, a decrease >20% from baseline or vasopressor administration. Secondary outcomes include oxygen desaturation, pulmonary aspiration, intubation difficulty (first-pass success and Cormack-Lehane grade), residual neuromuscular blockade and postoperative sore throat. Recruitment is planned over approximately 3 years and is ongoing. All analyses will follow the intention-to-treat principle.
ETHICS AND DISSEMINATION: The study has been approved by the Ethics Committee of the Medical Faculty, University of Leipzig, Germany (reference number: 193/23-ek). Results will be disseminated through peer-reviewed publications and presented at scientific conferences.
TRIAL REGISTRATION NUMBER: DRKS00031940.