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

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.

Study Overview

• Status: Completed
• Conditions: Intubation
• Intervention / Treatment: Procedure: Standard V-E ventilation technique; Procedure: Reversal V-E ventilation technique

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 Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: Standard V-E ventilation technique; For the two-handed standard V-E technique, the facemask is first placed over the bridge of the nose and mouth and then held in place by performing at two-handed jaw thrust maneuver with the index and second finger of each hand and maintaining mask contact with the patient's face by using both thumbs with mouth open. A head-tilt is performed by applying a caudal force on the mandible and mask.
Experimental: 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.	Procedure: Reversal V-E ventilation technique; While using reversal V-E technique, the anesthesia provider stands 180 degrees opposite from the head of the bed. Thenar eminence and thumbs secure the mask around the nose while the remaining fingers pull the mandible anteriorly while keeping the mouth open.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC of exhaled tidal volume (Vt) trace	Comparison of AUC of exhaled tidal volume trace	Period of masked ventilation (approximately 5 minutes)
Vt/AUC	Vt/AUC of exhaled Vt	Period of masked ventilation (approximately 5 minutes)
Peak inspiratory airway pressure	Peak inspiratory airway pressure	Period of masked ventilation (approximately 5 minutes)

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Christopher Canlas, M.D., Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): May 11, 2017
• Study Completion (Actual): May 11, 2017

Study Registration Dates

• First Submitted: May 15, 2017
• First Submitted That Met QC Criteria: May 26, 2017
• First Posted (Actual): May 30, 2017

Study Record Updates

• Last Update Posted (Actual): July 17, 2017
• Last Update Submitted That Met QC Criteria: July 12, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 170299

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No