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Clinical Trials/NCT03170037
NCT03170037CompletedNot Applicable

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

Vanderbilt University Medical Center1 site in 1 country92 target enrollmentStarted: April 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
92
Locations
1
Primary Endpoint
Visual score of friendliness of mask holding technique using 11 point scale

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

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

Arms & Interventions

Standard V-E ventilation technique

Active Comparator

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.

Intervention: Standard V-E ventilation technique (Procedure)

Reversal V-E ventilation technique

Experimental

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.

Intervention: Reversal V-E ventilation technique (Procedure)

Outcomes

Primary Outcomes

Visual score of friendliness of mask holding technique using 11 point scale

Time Frame: 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 Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Christopher Canlas

Assistant Professor

Vanderbilt University Medical Center

Study Sites (1)

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