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

NCT04617665 | Unknown

• 1 other identifier: Mask ventilation
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• centre of ventilation (CoV)

  8 weeks

• regional ventilation delay (RVD)

  8 weeks

• ventilation of regional lung ( %)

  8 weeks

• Expiratory tidal volume (TV)

  8 weeks

• PaO2/FiO2

  8 weeks

Study Arms (2)

One-handed mask ventilation

OTHER

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

Two-handed mask ventilation

OTHER

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

Interventions

One-handed mask ventilation OTHER

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

One-handed mask ventilation

Two-handed mask ventilation OTHER

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

Two-handed mask ventilation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Officials

• Jun Zhang, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Zhang, PhD

CONTACT

13817153025; snapzhang@aliyun.com

Li Yang, MD

CONTACT

18221847969; liyangmagic@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2020
• First Posted: November 5, 2020
• Study Start: November 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: November 5, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.