Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Gastroesophageal Regurgitation Under General Anesthesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02810912
Recruitment Status : Not yet recruiting
First Posted : June 23, 2016
Last Update Posted : June 23, 2016
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
The Episodes of Gastric Regurgitation Other: the effect of surgical position

Detailed Description:

Investigators aim to observe the occurrences of gastroesophageal regurgitation through the continuous monitoring with the novel technique of MII-pH during the perioperative period of a variety of common surgical procedures under SAD-based general anesthesia in this pilot study. Furthermore, investigators will also determine the factors associated with the occurrence of gastroesophageal regurgitation during these various surgical procedures under general anesthesia.

Investigators include the patients who will receive scheduled surgery under SAD-based general anesthesia and aged >= 20 will be enrolled. All subjects provide basic demographic data and fill in standard symptom questionnaire for evaluation of baseline severity of gastroesophageal reflux and other associated gastrointestinal and sleep symptoms. Supraglottic airway device with i-gel will be inserted to establish airway, and the gastric content will be suctioned out through the esophageal vent of i-gel. MII-pH catheter will be inserted though the esophageal vent of i-gel to detect and characterize gastroesophageal reflux events in the perioperative period. After removal of SAD, the patients were follow the saturation, sore throat or hoarseness in the postoperative care unit, as well as the possible complications.

Investigators will not only elucidate the clinical characteristics and risk factors in patients receiving elective surgeries, but also determine the severity of gastric regurgitation during the intraoperative period.

Investigators will correlate the reflux pattern, frequency, content and proximal extent of all reflux events and symptom correlation with clinical features in the intraoperative period. The study results could help us study more in the gastric regurgitation in perioperative period.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gastroesophageal Regurgitation During Perioperative Period Under General Anesthesia: a Pilot Study With Multichannel Intraluminal Impedance-pH Monitoring
Study Start Date : June 2016
Estimated Primary Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Group/Cohort Intervention/treatment
Supraglottic airway device-based anesthesia
Investigators planned to enroll 200 cases who will receive scheduled surgery under supraglottic airway device-based general anesthesia.
Other: the effect of surgical position
Investigators do not have intervention in the observation study. Investigators only use the MII-pH catheter to observe the episodes of gastric regurgitation in patients receiving supraglottic airway device under general anesthesia. Thus, investigators are going to observe the effect of surgical position change, body weight, surgical time. And investigators will have a control group, which patients undergo elective surgeries without surgical position change, no longer surgical time, and normal range of body weight.
Other Names:
  • the effect of body weight
  • The effect of surgical time
  • The standard elective surgery as control group




Primary Outcome Measures :
  1. episode of gastric regurgitation [ Time Frame: From the insertion of supraglottic airway device until removal of supraglottic airway device, whichever came first, assessed up to the total anesthetic time. ]

    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.



Secondary Outcome Measures :
  1. the effect of surgical position in episode of gastric regurgitation [ Time Frame: From the insertion of supraglottic airway device until removal of supraglottic airway device, whichever came first, assessed up to the total anesthetic time. ]
    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.


Other Outcome Measures:
  1. the effect of body weight in episode of gastric regurgitation [ Time Frame: From the insertion of supraglottic airway device until removal of supraglottic airway device, whichever came first, assessed up to the total anesthetic time. ]
    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.

  2. The effect of anesthetic time in episode of gastric regurgitation [ Time Frame: From the insertion of supraglottic airway device until removal of supraglottic airway device, whichever came first, assessed up to the total anesthetic time. ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients who will receive scheduled surgery under supraglottic airway device-based general anesthesia and aged >= 20 will be enrolled.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02810912


Contacts
Layout table for location contacts
Contact: Shouzen Fan, MD,PhD +886-972651601 shouzen@gmail.com

Sponsors and Collaborators
National Taiwan University Hospital
Layout table for additonal information
Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02810912    
Other Study ID Numbers: 201603012RIND
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: June 23, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We did not plan to share our data, because it involved the patients' privacy.
Additional relevant MeSH terms:
Layout table for MeSH terms
Laryngopharyngeal Reflux
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Laryngeal Diseases
Respiratory Tract Diseases