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

National Taiwan University

Status: Unknown

Conditions: The Comparison of the I-gel and Endotracheal Tube About in Different Ventilation Settings During Laparoscopic Surgery

Treatments: Drug: lidocaine, propofol, fentanyl and cisatracurium; Device: i-gel; Device: endotracheal tube

Study type: Interventional

Funder types: Other

Identifiers

NCT02462915

201502043RINC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

i-gel, an brand of supraglottic airway device

Experimental group

Description:

a supraglottic airway devices with a gastric suction channel

Treatment:

Device: i-gel

Drug: lidocaine, propofol, fentanyl and cisatracurium

endotracheal tube

Experimental group

Description:

traditional use for protect airway during the surgery

Treatment:

Device: endotracheal tube

Drug: lidocaine, propofol, fentanyl and cisatracurium