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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04617665
• Other study ID #: Mask ventilation
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2020
• Est. completion date: December 2020

Study information

• Verified date: October 2020
• Source: Fudan University
• Contact: Jun Zhang, PhD
• Phone: 13817153025
• Email: snapzhang[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia

Intervention

Other:
• One-handed mask ventilation
Using one-handed mask ventilation techniques during induction of general anesthesia
• Two-handed mask ventilation
Using two-handed mask ventilation techniques during induction of general anesthesia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Expiratory tidal volume (TV)	Expiratory tidal volume will be recorded through the anesthesia machine.	8 weeks
Secondary	PaO2/FiO2	PaO2/FiO2 will be recorded through arterial blood gas analysis.	8 weeks