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

NCT ID: NCT04617665

Last Updated: 2020-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-30

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type OTHER

One-handed mask ventilation

Intervention Type OTHER

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.

Group Type OTHER

Two-handed mask ventilation

Intervention Type OTHER

Using two-handed mask ventilation techniques during induction of general anesthesia

Interventions

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One-handed mask ventilation

Using one-handed mask ventilation techniques during induction of general anesthesia

Intervention Type OTHER

Two-handed mask ventilation

Using two-handed mask ventilation techniques during induction of general anesthesia

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jun Zhang, PhD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Central Contacts

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Jun Zhang, PhD

Role: CONTACT

[email protected]
13817153025

Li Yang, MD

Role: CONTACT

[email protected]
18221847969

Other Identifiers

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Mask ventilation

Identifier Type: -

Identifier Source: org_study_id