A Study Comparing the Supraglottic Airway Devices and Endotracheal Tube During Controlled Ventilation for Laparoscopic Surgery

In our study, we compared the ventilation performance of i-gel to the endotracheal tube during laparoscopic surgery.

The lungs were ventilated at tidal volumes (8mL/kg) using volume controlled. After that, we wanted to observe the respiratory parameters, such as leak fraction, leak volume, tidal volume, peak airway pressure and mean airway pressure.

In our hypothesis, the i-gel may be used reasonable alternative to tracheal tube during volume controlled ventilation in laparoscopic surgeries.

Study Overview

• Status: Unknown
• Conditions: The Comparison of the I-gel and Endotracheal Tube About in Different Ventilation Settings During Laparoscopic Surgery
• Intervention / Treatment: Device: i-gel; Drug: lidocaine, propofol, fentanyl and cisatracurium; Device: endotracheal tube

Detailed Description

In our study, we compared the ventilation performance of i-gel to the endotracheal tube during laparoscopic surgery.

Our patient receive i-gel or endotracheal tube by draw. These patients were Included by the criteria:1.ASA I-II2.Age from 20-80 years old, who were underwent elective GYN laparoscopic surgery and had ability to give inform consent.

The excluding criteria was: 1.presence of any significant lung, heart, brain disease 2. pathology of the neck or upper respiratory tract 3.Potential difficult intubation 4.an increased risk of aspiration, ex:gastroesophageal reflux, full stomach,Obese (BMI>30), and pregnant woman, who were confirmed by patient history and medical chart.

Preoxygenation was maintained for three minutes to avoid bag and mask ventilation. Anesthesia was induced with the routine medication, such as lidocaine、 propofol, fentanyl and cisatracurium. The i-gel or endotracheal tubes were inserted. The lungs were ventilated at the tidal volume (8mL/kg) using volume controlled. After that, we wanted to observe the respiratory parameters, such as leak fraction, leak volume, tidal volume, peak airway pressure and mean airway pressure.

In our hypothesis, the i-gel may be used reasonable alternative to tracheal tube during volume controlled ventilation in laparoscopic surgeries.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • Department of Anesthesiology, National Taiwan University Hospital
    • Contact: Shou-Zen Fan, MD,PhD; Phone Number: 62157 886-2-23123456; Email: shouzen@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• ASA I-II2.Age from 20-80 years old, who were underwent elective GYN laparoscopic surgery and had ability to give inform consent.

Exclusion Criteria:

• presence of any significant lung, heart, brain disease
• pathology of the neck or upper respiratory tract
• Potential difficult intubation
• an increased risk of aspiration, ex:gastroesophageal reflux, full stomach,
• Obese (BMI>30),
• pregnant woman, who were confirmed by patient history and medical chart

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: i-gel, an brand of supraglottic airway device; a supraglottic airway devices with a gastric suction channel	Device: i-gel; a supraglottic airway devices without cuff and the material was Styrene Ethylene Butadiene Styrene. gastric channel to the The gastric suction channel can facilitate venting and reduce the aspiration.; Drug: lidocaine, propofol, fentanyl and cisatracurium
Experimental: endotracheal tube; traditional use for protect airway during the surgery	Drug: lidocaine, propofol, fentanyl and cisatracurium; Device: endotracheal tube; traditional and regularly use in many surgeries for maintaining the airway.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
leak fraction	(inspiratory volume-expiratory volume)/inspiratory volume	intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
leak volume	inspiratory volume-expiratory volume	intraoperative

Other Outcome Measures

Outcome Measure	Time Frame
airway pressure	intraoperative

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Publications and helpful links

General Publications

• Uppal V, Fletcher G, Kinsella J. Comparison of the i-gel with the cuffed tracheal tube during pressure-controlled ventilation. Br J Anaesth. 2009 Feb;102(2):264-8. doi: 10.1093/bja/aen366.
• Lai CJ, Liu CM, Wu CY, Tsai FF, Tseng PH, Fan SZ. I-Gel is a suitable alternative to endotracheal tubes in the laparoscopic pneumoperitoneum and trendelenburg position. BMC Anesthesiol. 2017 Jan 6;17(1):3. doi: 10.1186/s12871-016-0291-1.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: June 1, 2015
• First Submitted That Met QC Criteria: June 3, 2015
• First Posted (Estimate): June 4, 2015

Study Record Updates

• Last Update Posted (Estimate): November 16, 2015
• Last Update Submitted That Met QC Criteria: November 13, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Membrane Transport Modulators; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Neuromuscular Agents; Neuromuscular Blocking Agents; Fentanyl; Propofol; Lidocaine; Cisatracurium
• Other Study ID Numbers: 201502043RINC