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

Not Applicable
Conditions
The Comparison of the I-gel and Endotracheal Tube About in Different Ventilation Settings During Laparoscopic Surgery
Interventions
Device: i-gel
Device: endotracheal tube
Registration Number
NCT02462915
Lead Sponsor
National Taiwan University Hospital
Brief Summary

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.

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
Female
Target Recruitment
40
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
i-gel, an brand of supraglottic airway devicei-gela supraglottic airway devices with a gastric suction channel
i-gel, an brand of supraglottic airway devicelidocaine, propofol, fentanyl and cisatracuriuma supraglottic airway devices with a gastric suction channel
endotracheal tubeendotracheal tubetraditional use for protect airway during the surgery
endotracheal tubelidocaine, propofol, fentanyl and cisatracuriumtraditional use for protect airway during the surgery
Primary Outcome Measures
NameTimeMethod
leak fractionintraoperative

(inspiratory volume-expiratory volume)/inspiratory volume

Secondary Outcome Measures
NameTimeMethod
leak volumeintraoperative

inspiratory volume-expiratory volume

Trial Locations

Locations (1)

Department of Anesthesiology, National Taiwan University Hospital

🇨🇳

Taipei, Taiwan

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