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

NCT03634449 | Unknown

• 1 other identifier: 201806063RINB
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroesophageal Reflux in Laparoscopy

Outcome Measures

Primary Outcomes (1)

• gastroesophageal reflux occurence

  occurence of the gastroesophageal reflux

  during the surgery

Secondary Outcomes (1)

• lower esophageal sphincter change

  during the surgery

Study Arms (2)

i-gel

EXPERIMENTAL

After anesthetic durg given, i-gel, a supraglottic airway devices with a gastric suction channel, will be inserted into the patients' airway.

Device: i-gel

endotracheal tube

ACTIVE COMPARATOR

After anesthetic durg given, the endotracheal tube, traditional use for protect airway during the laparoscopic surgery, will be inserted into the patients' airway.

Device: endotracheal tube

Interventions

i-gel DEVICE

i-gel is a supraglottic airway devices with a gastric suction channel.

i-gel

endotracheal tube DEVICE

Endotracheal intubation is a traditional use for protect airway during the laparoscopic surgery.

endotracheal tube

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Chih-Jun Lai

Taipei, Taiwan

RECRUITING

Central Study Contacts

Chih-Jun Lai, MD

CONTACT

0965327939; littlecherrytw@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: one group using the endotracheal tube one group using the i-gel

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: August 16, 2018
• Study Start: August 13, 2018
• Primary Completion: October 13, 2019
• Study Completion: September 13, 2020
• Last Updated: January 10, 2019

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)