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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02462915
Enrollment
40
Registered
2015-06-04
Start date
2015-06-30
Completion date
2017-12-31
Last updated
2015-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DEVICEi-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.

DEVICEendotracheal tube

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

DRUGlidocaine, propofol, fentanyl and cisatracurium

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
leak fractionintraoperative(inspiratory volume-expiratory volume)/inspiratory volume

Secondary

MeasureTime frameDescription
leak volumeintraoperativeinspiratory volume-expiratory volume

Other

MeasureTime frame
airway pressureintraoperative

Countries

Taiwan

Contacts

Primary ContactShou-Zen Fan, PhD,doctor
shouzen@gmail.com886-23123456
Backup ContactChih-Min Liu, Doctor
liu.chihmin@gmail.com886-972652224

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026