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

Department of Anesthesiology, Fudan University Shanghai Cancer Center, Fudan University, Shanghai, China.

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.

Study Overview

• Status: Unknown
• Conditions: Anesthesia
• Intervention / Treatment: Other: One-handed mask ventilation; Other: Two-handed mask ventilation

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
global inhomogeneity (GI)	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	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
centre of ventilation (CoV)	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.	8 weeks
regional ventilation delay (RVD)	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.	8 weeks
ventilation of regional lung ( %)	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.	8 weeks
Expiratory tidal volume (TV)	Expiratory tidal volume will be recorded through the anesthesia machine.	8 weeks
PaO2/FiO2	PaO2/FiO2 will be recorded through arterial blood gas analysis.	8 weeks

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2020
• Primary Completion (ANTICIPATED): December 1, 2020
• Study Completion (ANTICIPATED): December 1, 2020

Study Registration Dates

• First Submitted: October 25, 2020
• First Submitted That Met QC Criteria: November 4, 2020
• First Posted (ACTUAL): November 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 5, 2020
• Last Update Submitted That Met QC Criteria: November 4, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Mask ventilation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data or documents can be obtained by contact the corresponding authors. Files can be emailed to anyone that concerned.
• IPD Sharing Time Frame: During the submission and after the acceptance.
• IPD Sharing Access Criteria: Anyone who is interested in or has questions in this study.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No