NCT05979129Completed
Gastric Insufflation During Facemask Ventilation at Different Levels of End-expiratory Pressure in Obese Patients
Comparing the Incidence of Gastric Insufflation During Facemask Ventilation at Different Levels of End-expiratory Pressure During Induction of Anesthesia in Obese Patients: a Randomized Controlled Study
Source: ClinicalTrials.gov · Last updated 5 Aug 2024
Brief summary (registry, in English)
Gastric insufflation occurs when the inspiratory pressure exceeds the lower esophageal sphincter pressure. Thus, it is desirable to avoid excessive positive pressure during mask ventilation after induction of anesthesia and keeping the inspiratory pressure \<15-20 cmH2O.In patients with obesity the lower compliance of the respiratory system usually requires higher inspiratory pressures to maintain adequate ventilation making these patients more prone to gastric insufflation. This high risk of gastric insufflation can be aggravated by the use of positive end-expiratory pressure (PEEP) which is recommended to avoid lung atelectasis. The application of PEEP during mask ventilation increases the risk of gastric insufflation as it reduces the pressure threshold at which gastric insufflation occur The optimum ventilatory strategy during mask ventilation should achieve the balance between adequate lung ventilation and avoiding gastric insufflation. In obese patients, it is not clear whether the use of PEEP during mask ventilation would increase the risk of gastric insufflation or not. We hypothesize that using zero end-expiratory pressure (ZEEP) or low PEEP during mask ventilation would reduce the risk of gastric insufflation in comparison to high PEEP.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 162 (actual)
- First submitted
- 30 Jul 2023
- Start date
- 6 Aug 2023
- Primary completion date
- 28 Apr 2024
- Lead sponsor
- Kasr El Aini Hospital
- Diseases
- Obesity
- NCT number
- NCT05979129
What you commit to
- Study type: Interventional
- Participants enrolled: 162
- From 6 Aug 2023 to the primary completion date, 28 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients at increased risk of difficult mask ventilation: Mallampati classification \>2, presence of beard, limited neck extension, limited jaw protrusion, patients with history of obstructive sleep apnea or STOP-Bang score\>2
- Patients at risk of aspiration or history of esophageal reflux.
Other
- Patients with craniofacial anomalies, and pregnant patients
Who the study is looking for
- adult patients,
- with American Society of Anesthesiologists physical status II,
- body mass index \>35 kg/m2,
- scheduled for elective surgery under general anesthesia.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kasr Alaini hospital Coordinator of this site? Confirm its status | Cairo | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.