NCT02462915

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

November 16, 2015

Status Verified

November 1, 2015

Enrollment Period

1.5 years

First QC Date

June 1, 2015

Last Update Submit

November 13, 2015

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • leak fraction

    (inspiratory volume-expiratory volume)/inspiratory volume

    intraoperative

Secondary Outcomes (1)

  • leak volume

    intraoperative

Other Outcomes (1)

  • airway pressure

    intraoperative

Study Arms (2)

i-gel, an brand of supraglottic airway device

EXPERIMENTAL

a supraglottic airway devices with a gastric suction channel

Device: i-gelDrug: lidocaine, propofol, fentanyl and cisatracurium

endotracheal tube

EXPERIMENTAL

traditional use for protect airway during the surgery

Device: endotracheal tubeDrug: lidocaine, propofol, fentanyl and cisatracurium

Interventions

i-gelDEVICE

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.

i-gel, an brand of supraglottic airway device
endotracheal tubeDEVICE

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

endotracheal tube
lidocaine, propofol, fentanyl and cisatracuriumDRUG
endotracheal tubei-gel, an brand of supraglottic airway device

Eligibility Criteria

Age20 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-II2.Age from 20-80 years old, who were underwent elective GYN laparoscopic surgery and had ability to give inform consent.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Related Publications (2)

  • 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.

    PMID: 19151051BACKGROUND

  • 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.

    PMID: 28125979DERIVED

MeSH Terms

Interventions

LidocainePropofolFentanylcisatracurium

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Shou-Zen Fan, PhD,doctor

CONTACT

886-23123456shouzen@gmail.com

Chih-Min Liu, Doctor

CONTACT

886-972652224liu.chihmin@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2015

First Posted

June 4, 2015

Study Start

June 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2017

Last Updated

November 16, 2015

Record last verified: 2015-11

Locations

TW(1)