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Completed

NCT Number: NCT03170037

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  1. AUC of exhaled tidal volume (Vt) trace

    Time frame: Period of masked ventilation (approximately 5 minutes)

    Comparison of AUC of exhaled tidal volume trace

  2. Vt/AUC

    Time frame: Period of masked ventilation (approximately 5 minutes)

    Vt/AUC of exhaled Vt

  3. Peak inspiratory airway pressure

    Time frame: Period of masked ventilation (approximately 5 minutes)

    Peak inspiratory airway pressure

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 30, 2017
Registry last updated
Jul 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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