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

NCT03170037 | Completed

• 1 other identifier: 170299
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• AUC of exhaled tidal volume (Vt) trace

  Period of masked ventilation (approximately 5 minutes)

• Vt/AUC

  Period of masked ventilation (approximately 5 minutes)

• Peak inspiratory airway pressure

  Period of masked ventilation (approximately 5 minutes)

Study Arms (2)

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.

Procedure: Standard V-E ventilation technique

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.

Procedure: Reversal V-E ventilation technique

Interventions

Standard V-E ventilation technique PROCEDURE

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.

Standard V-E ventilation technique

Reversal V-E ventilation technique PROCEDURE

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.

Reversal V-E ventilation technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Study Officials

• Christopher Canlas, M.D.

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Comparison of 2 two-handed mask ventilation techniques' ease to anesthesia providers

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 30, 2017
• Study Start: April 1, 2017
• Primary Completion: May 11, 2017
• Study Completion: May 11, 2017
• Last Updated: July 17, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)