Comparison of Two-hand Mask Ventilation Technique: Standard V-E Versus Reversal V-E Technique

Not Applicable

Completed

• Conditions: Intubation
• Interventions: Procedure: Reversal V-E ventilation technique; Procedure: Standard V-E ventilation technique

• Registration Number: NCT03170037
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

This study hypothesizes that a novel reversal V-E ventilation technique will retain its high efficiency as that of standard V-E technique and will be easier to use.

Detailed Description

Despite advances in intubation technology, difficult airways persist. Because it is failure to oxygenate, not failure to intubate, that ultimately leads to brain injury and cardiovascular collapse, effective mask ventilation is at least as important as successful intubation. Therefore optimizing mask ventilation is crucial for clinicians. When difficult mask ventilation encounters, clinicians often switch to two hand technique to hold the mask including either "C-E" clamp or "V-E" clamp. Both volume mode ventilation and pressure mode ventilation are superior with the V-E technique as compared to the C-E technique. The study will test the hypothesis that a novel reversal V-E mask ventilation technique will retain its high efficiency as that of standard V-E technique but be easier to use than standard V-E technique.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2017-04-01
• Primary Completion: 2017-05-11
• Study Completion: 2017-05-11
• Study First Submitted: 2017-05-15
• Study First Submitted QC: 2017-05-26
• Study First Posted: 2017-05-30
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-12
• Last Update Posted: 2017-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

• Over 18 years of age
• Requiring general anesthesia
• BMI =>30

Read More

Exclusion Criteria

• Untreated ischemic heart diseases
• Respiratory disorders, including COPD and asthma
• American Society of Anesthesiologists(ASA) physical class of 4 or greater
• Undergoing emergency surgery
• Requiring rapid sequence intubation for aspiration protection
• Non propofol - induction of anesthesia
• Requiring fiberoptic intubation
• Pregnant women or women who have given birth within the last month

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Reversal V-E ventilation technique	Reversal V-E ventilation technique	After induction of anesthesia subject will be ventilated using the reversal V-E ventilation technique. Ventilation will be carried out using pressure mode ventilation at respiratory rate of 10 breaths per minute, I:E ratio of 1:2, peak inspiratory pressure of 20cmH2O and no PEEP. If the subjects can be adequately ventilated, as defined by perceivable chest movement and end tidal CO2 during the first three breaths, ventilation will continue for total ten breaths.
Standard V-E ventilation technique	Standard V-E ventilation technique	After induction of anesthesia subject will be ventilated using the standard V-E ventilation technique. Ventilation will be carried out using pressure mode ventilation at respiratory rate of 10 breaths per minute, I:E ratio of 1:2, peak inspiratory pressure of 20cmH2O and no PEEP. If the subjects can be adequately ventilated, as defined by perceivable chest movement and end tidal CO2 during the first three breaths, ventilation will continue for total ten breaths.

Primary Outcome Measures

Name	Time	Method
Visual score of friendliness of mask holding technique using 11 point scale	Conclusion of masked ventilation (approximately 5 minutes)	Visual score of friendliness of mask holding technique using 11 point scale when 0 is easy and 10 is difficult.

Secondary Outcome Measures

Name	Time	Method
AUC of exhaled tidal volume (Vt) trace	Period of masked ventilation (approximately 5 minutes)	Comparison of AUC of exhaled tidal volume trace
Peak inspiratory airway pressure	Period of masked ventilation (approximately 5 minutes)	Peak inspiratory airway pressure
Vt/AUC	Period of masked ventilation (approximately 5 minutes)	Vt/AUC of exhaled Vt

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States