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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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i-gel, an brand of supraglottic airway device

a supraglottic airway devices with a gastric suction channel

Group Type EXPERIMENTAL

i-gel

Intervention Type DEVICE

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.

lidocaine, propofol, fentanyl and cisatracurium

Intervention Type DRUG

endotracheal tube

traditional use for protect airway during the surgery

Group Type EXPERIMENTAL

endotracheal tube

Intervention Type DEVICE

traditional and regularly use in many surgeries for maintaining the airway.

lidocaine, propofol, fentanyl and cisatracurium

Intervention Type DRUG

Interventions

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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.

Intervention Type DEVICE

endotracheal tube

traditional and regularly use in many surgeries for maintaining the airway.

Intervention Type DEVICE

lidocaine, propofol, fentanyl and cisatracurium

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No