Clinical trial NCT02462915: A Study Comparing the Supraglottic Airway Devices and Endotracheal Tube During Controlled Ventilation for Laparoscopic Surgery
Official title: A Study Comparing the Supraglottic Airway Devices and Endotracheal Tube During Controlled Ventilation for Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: The Comparison of the I-gel and Endotracheal Tube About in Different Ventilation Settings During Laparoscopic Surgery
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2015-06-04
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: leak fraction
timeFrame: intraoperative
Secondary outcomes:
measure: leak volume
timeFrame: intraoperative
Other outcomes:
measure: airway pressure
timeFrame: intraoperative
Locations:
city: Taipei
country: Taiwan
facility: Department of Anesthesiology, National Taiwan University Hospital
Study officials:
References:
citation: 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.
citation: 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.