Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03634449 |
| Other study ID # |
201806063RINB |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 13, 2018 |
| Est. completion date |
September 13, 2020 |
Study information
| Verified date |
August 2018 |
| Source |
National Taiwan University Hospital |
| Contact |
Chih-Jun Lai, MD |
| Phone |
0965327939 |
| Email |
littlecherrytw[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
