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Status unknownNCT02097628wang002Updated Mar 27, 2014

Comparison of Two Ventilation Modes With Laryngeal Mask Airway Guardian

An interventional study of tidal volume and peak airway pressure in Gynecologic Disease, sponsored by Haiyun Wang. Status unknown. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-03-27.

Sponsored by Haiyun Wang · Not applicable and Interventional

The sponsor has not verified this record recently (last verified Mar 2014), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
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Study summary

The purpose of this study is to compare volume- and pressure- controlled ventilation with laryngeal mask airway Guardian in obese patients undergoing laparoscopic gynecologic surgery in terms of ventilatory efficacy, airway leak pressure (airway protection), ease-of-use and complications.

Read the detailed description

The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. The aim of the following perspective, randomized, blind trial study id to compare how the volume-controlled ventilation and pressure-controlled ventilation modes using the Laryngeal Mask Guardian affect the pulmonary mechanics, the gas exchange and the cardiovascular responses particularly in obese patients undergoing gynecological laparoscopy.

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Conditions studied

  • Gynecologic Disease

Keywords

  • volume controlled ventilation
  • pressure controlled ventilation
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In context

Genital Diseases, Female

154 studies on the registry are indexed under Genital Diseases, Female; 32 are open to participants now.

This study's planned enrollment of 40 is below the median of 80 across 111 interventional studies indexed under Genital Diseases, Female.

Browse Genital Diseases, Female studies →

Lead sponsor

This is the only study on the registry with Haiyun Wang as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Ambulatory patients scheduled to undergo laparoscopic gynecologic surgery under a short general paralysed anesthesia of less than 2 hours (ASA physical status I-II)
  • 18 to 65 years of age
  • A body mass index \<40 kg • m-2

Exclusion criteria

Exclusion Criteria:

  • Difficult airway
  • Recent history of upper respiratory tract infection and sore throats
  • A history of esophageal reflux disease
  • Kinesia patients
  • Inability to understand the Study Information Sheet and provide a written consent to take part in the study
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Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    pressure-controlled ventilation

    pressure-controlled ventilation: a peak airway pressure that provided a tidal volume of 8-12ml/kg with an upper limit of 35 centimeter water column, respiratory rate 12-16 times per minute.

    Procedure: peak airway pressure

  • Experimental
    volume-controlled ventilation

    volume-controlled ventilation: tidal volume 8-12ml/kg, respiratory rate 12-16 times per minute.

    Procedure: tidal volume

Interventions

  • Proceduretidal volume

    In the volume controlled ventilation group using laryngeal mask airway Guardian,a tidal volume of 8-12ml/kg,respiratory rate12-16bpm.

    Also known as: TV

  • Procedurepeak airway pressure

    In the pressure controlled ventilation group using laryngeal mask airway Guardian,a peak airway pressure that provides a tidal volume of 8-12ml/kg with an upper limit of 35 centimeter water column,respiratory rate12-16bpm.

    Also known as: airway peal pressure, peak pressure of aieway

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What researchers measure

Primary outcomes

  1. peak pressure

    The end-tidal carbon dioxide, the peak pressure, the mean airway pressure, the compliance were continuously monitored during the procedure and they were recorded at T1:just before carbon dioxide insufflation, T2: 30 minutes after carbon dioxide insufflation and T3: 10 minutes after the withdrawal of carbon dioxide. Data on gas exchange (pH、PaCO2、PaO2 ) at T1、T2 and T3 were recorded by artery blood gas analysis.

    Time frame: 5 min

Secondary outcomes

  1. Blood pressure

    including systolic blood pressure,diastolic blood pressure,mean arterial pressure.

    Time frame: intraoperative

  2. heart rate

    heart rate

    Time frame: intraoperative

Other outcomes

  1. Pharyngolaryngeal complication

    the presence of either sore throat, dysphonia or dysphagia at 1 and 24 h postoperatively

    Time frame: 1,24h

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02097628
Lead sponsor
Haiyun Wang
Collaborators
Tianjin Medical University General Hospital
Responsible party
Haiyun Wang (M.D., Ph.D., Tianjin Medical University General Hospital) — Sponsor-investigator
First posted
Mar 27, 2014
Start date
Apr 2014
Primary completion
Oct 2014 (estimated)
Completion
Dec 2014 (estimated)
Last update
Mar 27, 2014

Study contacts

Haiyun Wang, M.D., Ph.D
Contact
wanghy819@hotmail.com
13752211206
Zhiting Wen, M.D.
Contact
awen0829@163.com
13682191271
Haiyun Wang, M.D.Ph.D.
study chair · Tianjin Medical University General Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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