The Episodes of Gastric Regurgitation Clinical Trial
Official title:
Gastroesophageal Regurgitation During Perioperative Period Under General Anesthesia: a Pilot Study With Multichannel Intraluminal Impedance-pH Monitoring
| NCT number | NCT02810912 |
| Other study ID # | 201603012RIND |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | N/A |
| First received | June 12, 2016 |
| Last updated | June 20, 2016 |
| Start date | June 2016 |
Gastric regurgitation increases the risk of pulmonary aspiration in surgical patients receiving general anesthesia because of depression of gastro-esophageal reflux. In addition, some patients may have higher risk of aspiration as a result of reduced gastric emptying and gastroesophageal reflux, prolonged surgical time, and laparoscopic surgery. Second-generation supraglottic airway device (SAD) provides an additional channel to facilitate the drainage the gastric content to prevent from aspiration, which was routinely used in surgeries. Currently, multichannel intraluminal impedance-pH (MII-pH) monitoring, which combines multiple impedance channels to conventional pH catheters, is regarded as the most sensitive technique for detecting reflux events. Therefore, application of MII-pH monitoring on the SAD-based general anesthesia may help to detect ongoing reflux/regurgitation in the esophagus of patients during perioperative period. The hypothesis of the present study is that the occurrences of gastroesophageal regurgitation during general anesthesia may be influenced by the several factors, such as abdominal insufflation during laparoscopy, longer surgical time, Trendelenburg position, higher body weight, etc.
| Status | Not yet recruiting |
| Enrollment | 200 |
| Est. completion date | |
| Est. primary completion date | December 2021 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years and older |
| Eligibility |
Inclusion Criteria: 1. Patients who will receive scheduled surgery under SAD-based general anesthesia 2. Aged >= 20 Exclusion Criteria: 1. Major systemic disease, such as congestive heart failure, liver cirrhosis, end stage renal disease and malignancy. 2. Patients who have the risk of difficult ventilation or intubation. 3. pregnant women 4. prior nasal surgery or trauma 5. current use anticoagulant or antiplatelet agents 6. coagulopathy |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| National Taiwan University Hospital |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | the effect of body weight in episode of gastric regurgitation | MII-pH catheter will be inserted though the esophageal vent of i-gel to detect and characterize gastroesophageal reflux during the perioperative period. Continuous recording will be performed for perioperative period to assess the severity of gastric regurgitation. The investigators aim to observe the effect of body weight (BMI in kg/m2, weight in kilograms,height in meters) in episode of gastric regurgitation. The data will be analyzed using the package analysis software and will then be reviewed by software and corrected manually by an experienced gastroenterologist. Reflux numbers and reflux type (liquid and mixed), acidic (acid, weak-acid, alkaline) and proximal extent (height above LES) will be determined. | From the insertion of supraglottic airway device until removal of supraglottic airway device, whichever came first, assessed up to the total anesthetic time. | Yes |
| Other | The effect of anesthetic time in episode of gastric regurgitation | MII-pH catheter will be inserted though the esophageal vent of i-gel to detect and characterize gastroesophageal reflux during the perioperative period. Continuous recording will be performed for perioperative period to assess the severity of gastric regurgitation. The investigators aim to observe the effect of surgical time in episode of gastric regurgitation. The data will be analyzed using the package analysis software and will then be reviewed by software and corrected manually by an experienced gastroenterologist. Reflux numbers and reflux type (liquid and mixed), acidic (acid, weak-acid, alkaline) and proximal extent (height above LES) will be determined. | From the insertion of supraglottic airway device until removal of supraglottic airway device, whichever came first, assessed up to the total anesthetic time. | Yes |
| Primary | episode of gastric regurgitation | MII-pH catheter will be inserted though the esophageal vent of i-gel to detect and characterize gastroesophageal reflux during the perioperative period. Continuous recording will be performed for perioperative period to assess the severity of gastric regurgitation. The data will be analyzed using the package analysis software and will then be reviewed by software and corrected manually by an experienced gastroenterologist. Reflux numbers and reflux type (liquid and mixed), acidic (acid, weak-acid, alkaline) and proximal extent (height above LES) will be determined. The definition of total anesthetic time is from induction to removal of the i-gel. |
From the insertion of supraglottic airway device until removal of supraglottic airway device, whichever came first, assessed up to the total anesthetic time. | Yes |
| Secondary | the effect of surgical position in episode of gastric regurgitation | MII-pH catheter will be inserted though the esophageal vent of i-gel to detect and characterize gastroesophageal reflux during the perioperative period. Continuous recording will be performed for perioperative period to assess the severity of gastric regurgitation. The investigators aim to observe the effect of surgical position in episode of gastric regurgitation. The data will be analyzed using the package analysis software and will then be reviewed by software and corrected manually by an experienced gastroenterologist. Reflux numbers and reflux type (liquid and mixed), acidic (acid, weak-acid, alkaline) and proximal extent (height above LES) will be determined. | From the insertion of supraglottic airway device until removal of supraglottic airway device, whichever came first, assessed up to the total anesthetic time. | Yes |