Effect of an Endoscopic Bite Block on Mask Ventilation

Ventilator Lung Clinical Trial

Official title:

Effect of an Endoscopic Bite Block on Mask Ventilation in Anesthetized and Paralyzed Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03558620
• Other study ID #: 2018/00/0000
• Status: Completed
• Phase: N/A
• Start date: June 7, 2018
• Est. completion date: December 12, 2018

Study information

• Verified date: March 2019
• Source: SMG-SNU Boramae Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluation of effects of an endoscopic bite block on mask ventilation. In the present study, expiratory tidal volume and minute ventilation are measured under same pressure controlled mode in ventilator with three kinds of holding a mask. ( by one hand, one hand with an endoscopic bite block and two hand hold.)

Description:

Evaluation of effects of an endoscopic bite block on mask ventilation. In the present study, expiratory tidal volume and minute ventilation are measured under the same pressure controlled mode in ventilator (Pressure 15cmH2O, Respiratory rate 15/min, I:E=1:1) with three kinds of holding a mask. ( by one hand, one hand with an endoscopic bite block and two hand hold.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: December 12, 2018
• Est. primary completion date: December 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• patients scheduled for elective surgery under general anesthesia and agree with the purpose of the study

Exclusion Criteria:

• patients with diseases or structural abnormalities in the upper airway, wobbly teeth, and limited mouth opening of less than 3.5 cm or those who were at risk of aspiration

Related Conditions & MeSH terms

• Ventilator Lung

Intervention

Procedure:
• mask ventilation
mask ventilation (one-handed ventilation, one-handed with an endoscopic bite block, and two-handed ventilation)

Locations

Country	Name	City	State
Korea, Republic of	Seoul Metropolitan Government Seoul National University Boramae Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
SMG-SNU Boramae Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

Hart D, Reardon R, Ward C, Miner J. Face mask ventilation: a comparison of three techniques. J Emerg Med. 2013 May;44(5):1028-33. doi: 10.1016/j.jemermed.2012.11.005. Epub 2013 Mar 7. — View Citation

Joffe AM, Hetzel S, Liew EC. A two-handed jaw-thrust technique is superior to the one-handed "EC-clamp" technique for mask ventilation in the apneic unconscious person. Anesthesiology. 2010 Oct;113(4):873-9. doi: 10.1097/ALN.0b013e3181ec6414. — View Citation

Walsh JH, Maddison KJ, Platt PR, Hillman DR, Eastwood PR. Influence of head extension, flexion, and rotation on collapsibility of the passive upper airway. Sleep. 2008 Oct;31(10):1440-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expiratory tidal volume	Expiratory tidal volume with one-hand mask ventilation, one-handed mask ventilation with an endoscopic bite block, and two-handed ventilation	during mask ventilation after anesthesia induction
Secondary	Minute ventilation	Minute ventilationwith one-hand mask ventilation, one-handed mask ventilation with an endoscopic bite block, and two-handed ventilation	during mask ventilation after anesthesia induction
Secondary	Incidence of inadequate ventilation or dead space ventilation	Inadequate mask ventilation and dead-space ventilation are defined as a mean expiratory tidal volume of less than 4 mL kg-1 of predicted body weight and a mean expiratory tidal volume of less than 150 mL per breath with no clinical signs, respectively.	during mask ventilation after anesthesia induction