Safety of a rapid sequence induction
Conditions
Interventions
Group 1: intervention: Induction of anesthesia as rapid sequence induction:
For induction of anesthesia, the patient is in 10-30° anti-Trendenlenburg position and under standard monitoring with blood
mask ventilation is not used. Dosages are within the limits of approval and according to clinical judgment.
After 1 minute, the patient is intubated by primary direct laryngoscopy
the tube is on a guide rod, and cricoid pressure/Sellick handle is not used.
Group 2: control group: Induction of anesthesia as standard intubation with intermediate mask ventilation:
For induction o
Sponsors
Medizinische Fakultät, Universität Leipzig
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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 - Heartburn within the last 4 weeks - 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
Exclusion criteria: 1. lack of capacity to give consent by the patient himself 2. patients with room air saturation 45kg/m² - Pregnancy - Patients with ileus, subileus, intestinal obstruction or hiatal hernia. - Currently planned anti-reflux surgery - 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) 5. Planned intubation using a double lumen tube
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| composite endpoint (critical hypotension within 15 minutes after administration of injection hypnotic and before incision): - MAP below 65 mmHg for > 1 minute or - Need to administer a vasopressor (acrinor, epinephrine, norepinephrine) at any dose to maintain MAP or - A drop in MAP of 20% below baseline (MAP recorded for premedication) for > 1 minute. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Aspiration (one of the following criteria is met). - Evidence of non-pulmonary material underlying the vocal folds. - New-onset postoperative hypoxia, tachypnea, and corresponding infiltrate on chest x-ray explained by aspiration. • Incidence of oxygen saturation drop to <92% during induction. • Difficulty of intubation - Number of intubations with 1st pass success - Cormack-Lehane grade • Excess of relaxant, defined as TOF <0.9 at time of suture end or necessary reversal or antagonization • Intensity of sore throat by NRS at discharge from recovery room. | — |
Countries
Germany
Contacts
Public ContactSven Bercker
Universitätsklinikum Leipzig
Outcome results
None listed