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

Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03170037
• Other study ID #: 170299
• Status: Completed
• Phase: N/A
• First received: May 15, 2017
• Last updated: July 12, 2017
• Start date: April 1, 2017
• Est. completion date: May 11, 2017

Study information

• Verified date: July 2017
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: May 11, 2017
• Est. primary completion date: May 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intubation

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	AUC of exhaled tidal volume (Vt) trace	Comparison of AUC of exhaled tidal volume trace	Period of masked ventilation (approximately 5 minutes)
Secondary	Vt/AUC	Vt/AUC of exhaled Vt	Period of masked ventilation (approximately 5 minutes)
Secondary	Peak inspiratory airway pressure	Peak inspiratory airway pressure	Period of masked ventilation (approximately 5 minutes)