Indications for rapid sequence inductio

Not Applicable

Conditions: Safety of a rapid sequence induction

Registration Number: DRKS00031940

Lead Sponsor: Medizinische Fakultät, Universität Leipzig

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 792

Inclusion Criteria

1. clinical need to perform general anesthesia for elective procedures with an indication for the use of endotracheal intubation.
2. patients who meet one or more of the following criteria
- History of heartburn
- BMI =35kg/m² and =45kg/m²
- Diabetes mellitus with initial diagnosis more than 10 years ago
- History of surgical intervention on the stomach
- Esophageal varices without active bleeding in the last 4 weeks

Exclusion Criteria

1. lack of capacity to give consent by the patient himself
2. patients with room air saturation <95% on the floor of a structural heart/lung disease

3. patients with a high risk of aspiration, i.e.
- Patients with obesity BMI >45kg/m²
- Pregnancy
- Patients with ileus, subileus, intestinal obstruction or hiatal hernia.
- Non-fasted patients
- Gastric tube in place

4. patients with an expected difficult airway in the sense of an intubation by direct laryngoscopy not possible according to clinical assessment (head and neck tumors or corresponding previous operations, previously documented difficult intubation by direct laryngoscopy, ankylosing spondylitis or fractures of the cervical spine)

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
composite endpoint (critical hypotension within 15 minutes after administration of injection hypnotic and before incision):<br>- MAP below 65 mmHg for > 1 minute or<br>- Need to administer a vasopressor (acrinor, epinephrine, norepinephrine) at any dose to maintain MAP or<br>- A drop in MAP of 20% below baseline (MAP recorded for premedication) for > 1 minute.

Secondary Outcome Measures

Name	Time	Method
• Aspiration (one of the following criteria is met).<br>- Evidence of non-pulmonary material underlying the vocal folds.<br>- New-onset postoperative hypoxia, tachypnea, and corresponding infiltrate on chest x-ray explained by aspiration.<br>• Incidence of oxygen saturation drop to <92% during induction. <br>• Difficulty of intubation<br>- Number of intubations with 1st pass success<br>- Cormack-Lehane grade<br>• Excess of relaxant, defined as TOF <0.9 at time of suture end or necessary reversal or antagonization <br>• Intensity of sore throat by NRS at discharge from recovery room.