Gastroesophageal Function During General AnesthesiaNCT03332901
Gastroesophageal Function During Anesthesia
An observational study of Gastroesophageal Function During General Anesthesia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
General anesthesia may predispose patients to aspiration of gastroesophageal contents because of depression of protective reflexes during loss of consciousness. The laparoscopy would increase the intra-abdominal pressure, which is regarded as a predisposing factor of gastroesophageal reflux during the anesthesia. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Gastroesophageal Function During General Anesthesia
- How many people
- 15 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Mar 2018to 31 Dec 2022
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who will receive scheduled laparoscopic surgery under general anesthesia; Aged from 20-80 years old
Who may be able to join
- 1. Patients who will receive scheduled laparoscopic surgery under general anesthesia 2. Aged from 20-80 years old
Who cannot join
- 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. coagulopathy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Ya-Jung, Cheng
Taipei, Taiwan
Ya-Jung Cheng, Doctor
About this study
Official title: To Monitor the Effect on the Laparoscopic Pneumoperitoneum of Gastroesophageal Function During Anesthesia
General anesthesia may predispose patients to aspiration of gastroesophageal contents because of depression of protective reflexes during loss of consciousness. The laparoscopy would increase the intra-abdominal pressure, which is regarded as a predisposing factor of gastroesophageal reflux during the anesthesia. The lower esophageal sphincter is the important physiological mechanisms that prevent regurgitation and aspiration. However, the change of LES pressure and gastroesophageal reflux before and after laparoscopic physiological condition is still unknown because the prospective evaluation of gastroesophageal function in human is limited. In addition, the relationship between the change of intra-abdominal pressure and the LES pressure were still unknown, too. In this study, we aimed to observe the changes of gastroesophgeal function parameters by esophageal manometry, pH impedance, and intra-abdominal pressure measured by AbViser ®AutoValve®IAP Monitoring Device before and after laparoscopic condition.
Read the detailed description
Background: General anesthesia may predispose patients to aspiration of gastroesophageal contents because of depression of protective reflexes during loss of consciousness. The laparoscopy would increase the intra-abdominal pressure, which is regarded as a predisposing factor of gastroesophageal reflux during the anesthesia. The lower esophageal sphincter is the important physiological mechanisms that prevent regurgitation and aspiration. However, the change of LES pressure and gastroesophageal reflux before and after laparoscopic physiological condition is still unknown because the prospective evaluation of gastroesophageal function in human is limited. In addition, the relationship between the change of intra-abdominal pressure and the LES pressure were still unknown, too.
The esophageal manometry has pressure sensor to measure the LES pressure. The AbViser ®AutoValve®IAP Monitoring Device is a sterile non-invasive disposable monitoring device, that is routinely used to measure intra-abdominal pressure (IAP) in the intensive care unit. Therefore, application of esophageal manometry and pH impedance via second-generation SADs may help to detect gastroesophageal functional change and ongoing gastroesophageal regurgitation during perioperative period. We also used the AbViser ®AutoValve®IAP Monitoring Device to monitor the change of IAP before and after laparoscopic condition. In this study, we aimed to observe the changes of gastroesophgeal function parameters by esophageal manometry and intra-abdominal pressure measured by AbViser ®AutoValve®IAP Monitoring Device before and after laparoscopic condition.
Objectives: we aimed to observe the changes of gastroesophgeal function parameters by esophageal manometry, pH impedance, and intra-abdominal pressure measured by AbViser ®AutoValve®IAP Monitoring Device before and after laparoscopic condition.
Patients and methods: Consecutive patients who will receive scheduled laparoscopic surgery under general anesthesia and aged >= 20 will be enrolled. All subjects provide basic demographic data and fill in standard symptom questionnaire for evaluation of baseline upper gastrointestinal symptoms. After induction, the endotracheal tube (ETT) will be inserted to establish airway. Then, the esophageal manometry would be inserted to monitor the LES, and the AbViser ®AutoValve®IAP Monitoring Device will be inserted to monitor the IAP before and after the laparoscopic condition. After the surgery and removal of ETT, the patients will be followed for the oxygen saturation, sore throat or hoarseness in the postoperative care unit, as well as the possible complications.
Expected result: We will observe the changes of LES function, gastroesophageal reflux and the relationship between the IAP and the LES function before and after the laparoscopic condition.
- Being tested
- this is an observational study, no intervention required
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
this is an observational study, no intervention requiredOther
this is an observational study, no intervention required
What is being measured
The primary outcome is the main question the study is designed to answer.
lower esophaegal sphincter pressure
Measured: during the anesthesia
Secondary outcomes (1)
episodes of reflux
Measured: duirng the anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start21 Mar 2018
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Function During General AnesthesiaStudies 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ya-Jung Cheng, MD,PhD, Principal investigator, anesthesiology of department, National Taiwan university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03332901
- Sponsor's protocol ID
- 201708035RINA
- Status last verified
- Jan 2019
- First submitted
- 2 Nov 2017
- Last updated
- 9 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lai CJ, Chang WC, Huang CH, Liu CM, Lo YC, Cheng YJ. Detecting intraoperative gastric regurgitation by using preattached esophageal multichannel intraluminal impedance and pH monitoring on a solid-state manometry: a case series study. J Clin Monit Comput. 2020 Aug;34(4):853-859. doi: 10.1007/s10877-019-00380-2. Epub 2019 Aug 29.
PubMed 31468255
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Monitor the Effect on the Laparoscopic Pneumoperitoneum of Gastroesophageal Function During Anesthesia
- ClinicalTrials.gov ID
- NCT03332901
- Acronym / sponsor ID
- 201708035RINA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 21 Mar 2018 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 6 Nov 2017 (actual)
- 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.
General anesthesia may predispose patients to aspiration of gastroesophageal contents because of depression of protective reflexes during loss of consciousness. The laparoscopy would increase the intra-abdominal pressure, which is regarded as a predisposing factor of gastroesophageal reflux during the anesthesia. The lower esophageal sphincter is the important physiological mechanisms that prevent regurgitation and aspiration. However, the change of LES pressure and gastroesophageal reflux before and after laparoscopic physiological condition is still unknown because the prospective evaluation of gastroesophageal function in human is limited. In addition, the relationship between the change of intra-abdominal pressure and the LES pressure were still unknown, too. In this study, we aimed to observe the changes of gastroesophgeal function parameters by esophageal manometry, pH impedance, and intra-abdominal pressure measured by AbViser ®AutoValve®IAP Monitoring Device before and after laparoscopic condition.
Detailed description
Background: General anesthesia may predispose patients to aspiration of gastroesophageal contents because of depression of protective reflexes during loss of consciousness. The laparoscopy would increase the intra-abdominal pressure, which is regarded as a predisposing factor of gastroesophageal reflux during the anesthesia. The lower esophageal sphincter is the important physiological mechanisms that prevent regurgitation and aspiration. However, the change of LES pressure and gastroesophageal reflux before and after laparoscopic physiological condition is still unknown because the prospective evaluation of gastroesophageal function in human is limited. In addition, the relationship between the change of intra-abdominal pressure and the LES pressure were still unknown, too.
The esophageal manometry has pressure sensor to measure the LES pressure. The AbViser ®AutoValve®IAP Monitoring Device is a sterile non-invasive disposable monitoring device, that is routinely used to measure intra-abdominal pressure (IAP) in the intensive care unit. Therefore, application of esophageal manometry and pH impedance via second-generation SADs may help to detect gastroesophageal functional change and ongoing gastroesophageal regurgitation during perioperative period. We also used the AbViser ®AutoValve®IAP Monitoring Device to monitor the change of IAP before and after laparoscopic condition. In this study, we aimed to observe the changes of gastroesophgeal function parameters by esophageal manometry and intra-abdominal pressure measured by AbViser ®AutoValve®IAP Monitoring Device before and after laparoscopic condition.
Objectives: we aimed to observe the changes of gastroesophgeal function parameters by esophageal manometry, pH impedance, and intra-abdominal pressure measured by AbViser ®AutoValve®IAP Monitoring Device before and after laparoscopic condition.
Patients and methods: Consecutive patients who will receive scheduled laparoscopic surgery under general anesthesia and aged >= 20 will be enrolled. All subjects provide basic demographic data and fill in standard symptom questionnaire for evaluation of baseline upper gastrointestinal symptoms. After induction, the endotracheal tube (ETT) will be inserted to establish airway. Then, the esophageal manometry would be inserted to monitor the LES, and the AbViser ®AutoValve®IAP Monitoring Device will be inserted to monitor the IAP before and after the laparoscopic condition. After the surgery and removal of ETT, the patients will be followed for the oxygen saturation, sore throat or hoarseness in the postoperative care unit, as well as the possible complications.
Expected result: We will observe the changes of LES function, gastroesophageal reflux and the relationship between the IAP and the LES function before and after the laparoscopic condition.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will receive scheduled laparoscopic surgery under general anesthesia; Aged from 20-80 years old
Key inclusion criteria (1 listed)
- 1. Patients who will receive scheduled laparoscopic surgery under general anesthesia 2. Aged from 20-80 years old
Key exclusion criteria (2 listed)
- 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. coagulopathy
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 |
|---|---|---|
| this is an observational study, no intervention requiredthis is an observational study, no intervention required | Other | – |
Primary outcome
lower esophaegal sphincter pressure
Time frame: during the anesthesia
1 secondary outcome
episodes of reflux
Time frame: duirng the anesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
- Derived from this study: PubMed 31468255Lai CJ, Chang WC, Huang CH, Liu CM, Lo YC, Cheng YJ. Detecting intraoperative gastric regurgitation by using preattached esophageal multichannel intraluminal impedance and pH monitoring on a solid-state manometry: a case series study. J Clin Monit Comput. 2020 Aug;34(4):853-859. doi: 10.1007/s10877-019-00380-2. Epub 2019 Aug 29.
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.
Ya-Jung Cheng, MD,PhD principal investigator
anesthesiology of department, National Taiwan university hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Function During General Anesthesia, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 2 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 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Chih-Jun Lai, MD (+886-972652086, littlecherrytw@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lower esophaegal sphincter pressure (time frame: during the anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03332901, which also lists 1 linked publication.
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 9 Jan 2019.