| Registry | NCT03239236 |
|---|---|
| Status | Withdrawn - no funding available |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Sponsor | Medical University of Vienna (Other) |
| Conditions | Anesthesia Intubation Complication |
| Interventions | Rapid sequence induction t-RSI, Rapid sequence induction m-RSI-PEEP, Rapid sequence induction m-RSI-vent, m-RSI-vent-cric, Cricoid Pressure, Anesthetics, Aspiration of gastric air via nasogastric tube, Impression of gastric inflation at laparoscopy., Arterial blood gas (Procedure, drug, diagnostic test) |
| Dates | start 2021-02-01 (estimated), primary completion 2021-02-01 (estimated), completion 2021-02-01 (estimated), first posted 2017-08-04, last updated 2021-02-18 |
| Locations | 1 site in Austria |
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All trials for Anesthesia Intubation Complication All trials of Rapid sequence induction t-RSI All trials of Rapid sequence induction m-RSI-PEEP
This study investigates the effect of 4 different methods of rapid sequence induction (RSI) in morbidly obese patients on the amount of air insufflation into the stomach.
100 adult patients with a body mass index > 40 undergoing elective laparoscopic surgery will be included. Patients with a history of previous bariatric surgery or with an anticipated difficult airway will be excluded.
The randomization will be 1:1:1:1 stratified for gastro-esophageal reflux disease.
All groups will receive standardized preoperative continuous positive airway pressure (CPAP) therapy.
In the operation theater, Group one will receive pre-oxygenation for 3 minutes via a tight fitting face mask without positive end-expiratory pressure (PEEP). Induction agents will be administered as quick boluses (Propofol 2,5mg/kg total body weight, max 350mg, Fentanyl 250mcg, Rocuronium 1,2mg/kg ideal body weight) and tracheal intubation will be performed after 1 minute. No bag mask ventilation will be performed in-between.
Group 2 will receive pre-oxygenation via a tight face mask with a PEEP of 10 mbar for 3 minutes. The same induction agents as in group one will be administered. PEEP via facemask will be continued for one minute and tracheal intubation will be performed.
Group 3 will receive pre-oxygenation via a tight fitting facemask with a PEEP of 10 mbar with additional pressure support of 8 mbar and a back up ventilation frequency will be set to 10/min. After the same induction agents are given as in group 1, patients will receive non-invasive ventilation via ventilator at the settings described earlier for group 3.
Group 4 will receive the same induction as group 3, in addition a cricoid pressure will be applied during the non invasive ventilation.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| t-RSI | Experimental | Procedure: Rapid sequence induction t-RSI; Drug: Anesthetics; Diagnostic Test: Aspiration of gastric air via nasogastric tube; Diagnostic Test: Impression of gastric inflation at laparoscopy.; Diagnostic Test: Arterial blood gas | Rapid sequence induction t-RSI. Traditional rapid sequence induction with Anesthetics. Preoxygenation via face mask, no ventilation with no PEEP until intubation. Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy. Arterial blood gas samples will be taken at different time points. |
| m-RSI-PEEP | Experimental | Procedure: Rapid sequence induction m-RSI-PEEP; Drug: Anesthetics; Diagnostic Test: Aspiration of gastric air via nasogastric tube; Diagnostic Test: Impression of gastric inflation at laparoscopy.; Diagnostic Test: Arterial blood gas | Rapid sequence induction m-RSI-PEEP. Modified rapid sequence induction with Anesthetics and PEEP. Preoxygenation via facemask with PEEP of 10 mbar. PEEP will be continued until intubation. Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy. Arterial blood gas samples will be taken at different time points. |
| m-RSI-vent | Experimental | Procedure: Rapid sequence induction m-RSI-vent; Drug: Anesthetics; Diagnostic Test: Aspiration of gastric air via nasogastric tube; Diagnostic Test: Impression of gastric inflation at laparoscopy.; Diagnostic Test: Arterial blood gas | Rapid sequence induction m-RSI-vent. Modified rapid sequence induction with Anesthetics and intermittent ventilation. Preoxygenation via facemask with 10 mbar PEEP and 8 mbar pressure support. Backup frequency set at 10/min. Ventilation via anesthetic machine until intubation. Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy. Arterial blood gas samples will be taken at different time points. |
| m-RSI-vent-cric | Experimental | Procedure: m-RSI-vent-cric; Procedure: Cricoid Pressure; Drug: Anesthetics; Diagnostic Test: Aspiration of gastric air via nasogastric tube; Diagnostic Test: Impression of gastric inflation at laparoscopy.; Diagnostic Test: Arterial blood gas | Rapid sequence induction m-RSI-vent-cric. Modified rapid sequence induction with Anesthetics and intermittent ventilation and cricoid pressure. Same as "modified rapid sequence induction with intermittent ventilation" arm with additional cricoid pressure. Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy. Arterial blood gas samples will be taken at different time points. |
Sex: All, ages: 19 Years to any
Inclusion Criteria: * BMI > 40 * American Society of Anesthesiology Class 1-3 * Elective laparoscopic surgery Exclusion Criteria: * Pregnant or breastfeeding patients * Previous bariatric surgery * Anticipated difficult airway
| Facility | City | Country | Status |
|---|---|---|---|
| Medical University of Vienna | Vienna | Austria |