Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of One-handed and Two-handed Mask Ventilation Techniques on Global and Regional Lung Ventilation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04617665
Recruitment Status : Not yet recruiting
First Posted : November 5, 2020
Last Update Posted : November 5, 2020
Sponsor:
Information provided by (Responsible Party):
Fudan University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Two-handed mask ventilation has been shown to provide higher tidal volume than one-handed mask ventilation. The effects of the two techniques on respiratory mechanics during induction of general anesthesia, however, still need to be determined.

Condition or disease Intervention/treatment Phase
Anesthesia Other: One-handed mask ventilation Other: Two-handed mask ventilation Not Applicable

Detailed Description:
Mask positive pressure ventilation always causes the changes of respiratory mechanics such as ventral redistribution of regional ventilation, which impairs gas exchange. Two-handed mask ventilation has been shown to improve gas exchange by providing higher tidal volume than one-handed mask ventilation. We hypothesis that those higher tidal volume caused by two-handed mask ventilation would also improve the respiratory mechanics during induction of general anesthesia.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Department of Anesthesiology, Fudan University Shanghai Cancer Center, Fudan University, Shanghai, China.
Estimated Study Start Date : November 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
One-handed mask ventilation
For the one-handed mask ventilation, only one hand can be used to achieve the face mask seal. The left thumb and index finger form a ''C,'' providing anterior pressure over the mask, while the third, fourth, and fifth fingers form an ''E'' to lift the jaw.
 Other: One-handed mask ventilation
Using one-handed mask ventilation techniques during induction of general anesthesia
Two-handed mask ventilation
For the two-handed mask ventilation, the provider's thumb and thenar eminence of each hand are held parallel, adjacent to the mask connector, and depress each side of the mask. The second through fifth digits wrap around and elevate the mandible to draw it anteriorly into the mask establishing both a jaw-thrust and chin-lift maneuver when appropriate.
 Other: Two-handed mask ventilation
Using two-handed mask ventilation techniques during induction of general anesthesia


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. global inhomogeneity (GI) [ Time Frame: 8 weeks ]
    EIT images will be acquired by using the EIT monitor (Drager Medical Gmbh, Lubeck, Germany). And a software package (Electrical impedance tomography diag custom software provided by Drager Medical) will be used to quantitatively analyze the EIT data. 0% = homogenous


Secondary Outcome Measures :
  1. centre of ventilation (CoV) [ Time Frame: 8 weeks ]
    EIT images will be acquired by using the EIT monitor (Drager Medical Gmbh, Lubeck, Germany). And a software package (Electrical impedance tomography diag custom software provided by Drager Medical) will be used to quantitatively analyze the EIT data. 100% = entirely dorsal.

  2. regional ventilation delay (RVD) [ Time Frame: 8 weeks ]
    EIT images will be acquired by using the EIT monitor (Drager Medical Gmbh, Lubeck, Germany). And a software package (Electrical impedance tomography diag custom software provided by Drager Medical) will be used to quantitatively analyze the EIT data.

  3. ventilation of regional lung ( %) [ Time Frame: 8 weeks ]
    EIT images will be acquired by using the EIT monitor (Drager Medical Gmbh, Lubeck, Germany). And a software package (Electrical impedance tomography diag custom software provided by Drager Medical) will be used to quantitatively analyze the EIT data.

  4. Expiratory tidal volume (TV) [ Time Frame: 8 weeks ]
    Expiratory tidal volume will be recorded through the anesthesia machine.

  5. PaO2/FiO2 [ Time Frame: 8 weeks ]
    PaO2/FiO2 will be recorded through arterial blood gas analysis.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Scheduled for elective surgery with general anesthesia
  • American Society of Anesthesiologist (ASA) physical class of I-II.

Exclusion Criteria:

  • acute and chronic respiratory disorders, including chronic obstructive
  • pulmonary disease (COPD) and asthma;
  • a history of lung surgery;
  • exist risk of reflux and aspiration;
  • patients requiring an awake intubation;
  • facial and thoracic deformities;
  • implants exist in the body, such as cardiac pacemakers;
  • pregnant women.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04617665


Contacts
Layout table for location contacts
Contact: Jun Zhang, PhD 13817153025 snapzhang@aliyun.com
Contact: Li Yang, MD 18221847969 liyangmagic@sina.com

Sponsors and Collaborators
Fudan University
Investigators
Layout table for investigator information
Principal Investigator: Jun Zhang, PhD Fudan University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Fudan University
ClinicalTrials.gov Identifier: NCT04617665    
Other Study ID Numbers: Mask ventilation
First Posted: November 5, 2020    Key Record Dates
Last Update Posted: November 5, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data or documents can be obtained by contact the corresponding authors. Files can be emailed to anyone that concerned.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: During the submission and after the acceptance.
Access Criteria: Anyone who is interested in or has questions in this study.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No