The Episodes of Gastric RegurgitationNCT02810912
Gastroesophageal Regurgitation Under General Anesthesia
An observational study of The Episodes of Gastric Regurgitation, run by National Taiwan University Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- The Episodes of Gastric Regurgitation
- What is being tested?
- the effect of surgical position
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients who will receive scheduled surgery under supraglottic airway device-based general anesthesia and aged >= 20 will be enrolled.
Who may be able to join
- Patients who will receive scheduled surgery under SAD-based general anesthesia
- Aged >= 20
Who cannot join
- Major systemic disease, such as congestive heart failure, liver cirrhosis, end stage renal disease and malignancy.
- Patients who have the risk of difficult ventilation or intubation.
- pregnant women
- prior nasal surgery or trauma
- current use anticoagulant or antiplatelet agents
- coagulopathy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Gastroesophageal Regurgitation During Perioperative Period Under General Anesthesia: a Pilot Study With Multichannel Intraluminal Impedance-pH Monitoring
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.
Read the 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.
- Conditions
- The Episodes of Gastric Regurgitation
- Being tested
- the effect of surgical position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the effect of surgical positionOther
Also called the effect of body weight, The effect of surgical time, The standard elective surgery as control group
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.
| Study group | Role | What they receive |
|---|---|---|
| Supraglottic airway device-based anesthesia | Investigators planned to enroll 200 cases who will receive scheduled surgery under supraglottic airway device-based general anesthesia. Receives: Other: the effect of surgical position |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the insertion of supraglottic airway device until removal of supraglottic airway device, whichever came first, assessed up to the total anesthetic time.
Secondary outcomes (1)
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.
Measured: From the insertion of supraglottic airway device until removal of supraglottic airway device, whichever came first, assessed up to the total anesthetic time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Episodes of Gastric RegurgitationStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02810912
- Sponsor's protocol ID
- 201603012RIND
- Status last verified
- Jun 2016
- First submitted
- 12 Jun 2016
- Last updated
- 23 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: We did not plan to share our data, because it involved the patients' privacy.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastroesophageal Regurgitation During Perioperative Period Under General Anesthesia: a Pilot Study With Multichannel Intraluminal Impedance-pH Monitoring
- ClinicalTrials.gov ID
- NCT02810912
- Acronym / sponsor ID
- 201603012RIND
- Conditions
- The Episodes of Gastric Regurgitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Dec 2021 (estimated)
- First posted
- 23 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supraglottic airway device-based anesthesia | – | Other: the effect of surgical positionInvestigators planned to enroll 200 cases who will receive scheduled surgery under supraglottic airway device-based general anesthesia. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients who will receive scheduled surgery under supraglottic airway device-based general anesthesia and aged >= 20 will be enrolled.
Key inclusion criteria (2 listed)
- Patients who will receive scheduled surgery under SAD-based general anesthesia
- Aged >= 20
Key exclusion criteria (6 listed)
- Major systemic disease, such as congestive heart failure, liver cirrhosis, end stage renal disease and malignancy.
- Patients who have the risk of difficult ventilation or intubation.
- pregnant women
- prior nasal surgery or trauma
- current use anticoagulant or antiplatelet agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the effect of surgical positionAlso: the effect of body weight, The effect of surgical time, The standard elective surgery as control groupInvestigators 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 | Supraglottic airway device-based anesthesia |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2016.
- Individual participant dataSharing planned: No. We did not plan to share our data, because it involved the patients' privacy.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of The Episodes of Gastric Regurgitation, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shouzen Fan, MD,PhD (+886-972651601, shouzen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2016.