Comparison of Two Ventilation Modes With Laryngeal Mask Airway Guardian

NCT02097628 | Unknown DMC

• 1 other identifier: wang002
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Gynecologic Disease

Keywords

volume controlled ventilation; pressure controlled ventilation

Outcome Measures

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.

  5 min

Secondary Outcomes (2)

• Blood pressure

  intraoperative

• heart rate

  intraoperative

Other Outcomes (1)

• Pharyngolaryngeal complication

  1,24h

Study Arms (2)

pressure-controlled ventilation

ACTIVE COMPARATOR

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

volume-controlled ventilation

EXPERIMENTAL

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

Procedure: tidal volume

Interventions

tidal volume PROCEDURE

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

volume-controlled ventilation

peak airway pressure PROCEDURE

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

pressure-controlled ventilation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haiyun Wang: lead
• Tianjin Medical University General Hospital: collaborator

MeSH Terms

Conditions

Genital Diseases, Female

Interventions

Tidal Volume

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Inspiratory Capacity; Vital Capacity; Total Lung Capacity; Lung Volume Measurements; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Haiyun Wang, M.D.Ph.D.

  Tianjin Medical University General Hospital

  STUDY CHAIR

Central Study Contacts

Haiyun Wang, M.D., Ph.D

CONTACT

13752211206; wanghy819@hotmail.com

Zhiting Wen, M.D.

CONTACT

13682191271; awen0829@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D., Ph.D.

Study Record Dates

• First Submitted: March 18, 2014
• First Posted: March 27, 2014
• Study Start: April 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 27, 2014

Record last verified: 2014-03