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

NCT ID: NCT03170037

Last Updated: 2017-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2017-05-11

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.

Conditions

Intubation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Standard V-E ventilation technique

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Reversal V-E ventilation technique

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Christopher Canlas

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher Canlas, M.D.

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

170299

Identifier Type: -

Identifier Source: org_study_id