Risks of Gastroesophageal Reflux in the Endotracheal Intubation or the I-gel

Not Applicable

• Conditions: Gastroesophageal Reflux in Laparoscopy
• Interventions: Device: i-gel; Device: endotracheal tube

• Registration Number: NCT03634449
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

In the use of the second supraglottic airway device- i-gel in the laparoscopic pneumoperitoneum and Trendelenburg (LPT) surgical positioning, our data reported that the leak fraction in the i-gel group was higher than in the endotracheal tube group.1 These air leak may be gone into the GI tract and cause the gastric distension resulting in the increasing risk of aspiration. Few studies investigated whether the risk of occurrence of the gastroesophageal reflux (GER), the changes of the lower esophageal sphincter (LES) while the GER occurred, and the stomach fullness in the i-gel group than in the endotracheal tube group.

We aim to observe the changes of gastroesophageal function parameters by esophageal manometry, pH impedance, and intra-abdominal pressure before and after laparoscopic pneumoperitoneum during anesthesia, all via the second SADs.

Detailed Description

Background: In the use of the second supraglottic airway device- i-gel in the laparoscopic pneumoperitoneum and Trendelenburg (LPT) surgical positioning, our data reported that the leak fraction in the i-gel group was higher than in the endotracheal tube group.1 These air leak may be gone into the GI tract and cause the gastric distension resulting in the increasing risk of aspiration. Few studies investigated whether the risk of occurrence of the gastroesophageal reflux (GER), the changes of the lower esophageal sphincter (LES) while the GER occurred, and the stomach fullness in the i-gel group than in the endotracheal tube group. The LES is the important physiological mechanisms that prevent regurgitation and aspiration. The previous study has been investigated that LES would have adaptive response in using the endotracheal tube in the LPT setting. However, the change of LES pressure and gastroesophageal reflux during the LPT surgical settings using the i-gel is still unknown.

The esophageal manometry has pressure sensor to measure the LES pressure. The combined esophageal multichannel intraluminal impedance and pH monitoring (MII -pH) could not only detect the acidic reflux or weakly acidic reflux, but also the height of the regurgitant. We also used the abdominal echo in check the gastric volume before and after the surgery.

Objectives: we aimed to compare the changes of lower esophageal sphincter pressure (LESP) and the occurrence of the GER during the LPT setting by esophageal manometry and MII-pH monitor between the endotracheal tube (ETT) and the i-gel group. The gastric volume before and after surgery has been checked by abdominal echo. We also observed the respiratory parameters changes while the GER occurred.

Patients and methods: Consecutive patients who will receive scheduled laparoscopic surgery under general anesthesia and aged from 20 to 80 years old will be enrolled. All subjects provide basic demographic data. The patients have been randomized into the i-gel or ETT group by sealing envelope. After induction, the MII-pH monitor has been pre-attached to the esophageal manometry. Then they will be inserted into the esophagus. The patients have received the ETT or i-gel. Then the respiratory parameters were collected by the GE S/5 Compact Anesthesia Monitor (GE Healthcare, Helsinki, Finland) with a spirometry tube (GE Healthcare, Helsinki, Finland) and D-lite sensor (GE Healthcare, Helsinki, Finland). The data have been continuous recorded. There were four time point of the LESP measured: (1)T1, after induction (without muscle relaxant) (2)T2, ETT or i-gel intubation (3)T3, after LPT setting (4) T4, off LPT setting.

Expected result: We will compared the difference between the patients receiving the i-gel or ETT group about the (1) the changes of LESP in the above four time point (2) the occurrence of the GER and the relationship between the LES and GER (3) gastric volume before and after surgery.

Study Timeline

• Status Verified: 2018-08
• Study First Submitted: 2018-08-09
• Study Start: 2018-08-13
• Study First Submitted QC: 2018-08-14
• Study First Posted: 2018-08-16
• Last Update Submitted: 2019-01-08
• Last Update Posted: 2019-01-10
• Primary Completion: 2019-10-13
• Study Completion: 2020-09-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients who will receive scheduled surgery with laparoscopic pneumoperitoneum and Trendelenburg (LPT) setting under general anesthesia
• Aged from 20-80 years old

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Exclusion Criteria

• 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
• coagulopathy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
i-gel	i-gel	After anesthetic durg given, i-gel, a supraglottic airway devices with a gastric suction channel, will be inserted into the patients' airway.
endotracheal tube	endotracheal tube	After anesthetic durg given, the endotracheal tube, traditional use for protect airway during the laparoscopic surgery, will be inserted into the patients' airway.

Primary Outcome Measures

Name	Time	Method
gastroesophageal reflux occurence	during the surgery	occurence of the gastroesophageal reflux

Secondary Outcome Measures

Name	Time	Method
lower esophageal sphincter change	during the surgery	lower esophageal sphincter change during the surgery

Trial Locations

Locations (1)

Chih-Jun Lai; 🇨🇳 Taipei, Taiwan