NCT02580526

Brief Summary

This study compares the effectiveness of two kinds of two-handed facemask ventilation techniques (when breathing is supported with machines) at the time that general anesthesia is started. Study participants will start with one technique and then cross over to the other technique.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 20, 2015

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2015

Completed
Last Updated

July 11, 2017

Status Verified

July 1, 2017

Enrollment Period

3 months

First QC Date

October 16, 2015

Last Update Submit

July 5, 2017

Conditions

Apnea

Outcome Measures

Primary Outcomes (1)

  • Difference in expired tidal volume for one minute of each technique

    one minute of expired tidal volume for each mask ventilation technique

Study Arms (2)

V-E mask ventilation technique crossover C-E mask ventilation

ACTIVE COMPARATOR
Procedure: V-E mask ventilation for one minuteProcedure: C-E mask ventilation for one minute

C-E mask ventilation technique crossover V-E mask ventilation

ACTIVE COMPARATOR
Procedure: V-E mask ventilation for one minuteProcedure: C-E mask ventilation for one minute

Interventions

V-E mask ventilation for one minutePROCEDURE

V-E approach maintains mouth open, creates larger oral cavity and allow positive pressure generated during inspiration to push forwards submandibular region. When apnea occurs after anesthesia induction subjects will be ventilated with one of the two techniques randomly, either two-handed "C-E" facemask ventilation technique or with "V-E" technique. Ventilation will be carried out using pressure mode ventilation at respiratory rate of 10 breaths per minute. Subject will start with one technique and then cross over to the other technique.

C-E mask ventilation technique crossover V-E mask ventilationV-E mask ventilation technique crossover C-E mask ventilation
C-E mask ventilation for one minutePROCEDURE

Using C-E technique, the operator's fingers pressure mouth closed and push posteriorily the soft tissue of submandibular region. When apnea occurs after anesthesia induction subjects will be ventilated with one of the two techniques randomly, either two-handed "C-E" facemask ventilation technique or with "V-E" technique . Ventilation will be carried out using pressure mode ventilation at respiratory rate of 10 breaths per minute. Subject will start with one technique and then cross over to the other technique.

C-E mask ventilation technique crossover V-E mask ventilationV-E mask ventilation technique crossover C-E mask ventilation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>18 years of age
  • Requiring general anesthesia in the main operating rooms at Vanderbilt University Medical Center
  • BMI greater than 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,
  • Induction of anesthesia is not done with IV propofol,
  • Requiring fiberoscopic intubation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Related Publications (9)

  • Cheney FW, Posner KL, Lee LA, Caplan RA, Domino KB. Trends in anesthesia-related death and brain damage: A closed claims analysis. Anesthesiology. 2006 Dec;105(6):1081-6. doi: 10.1097/00000542-200612000-00007.

    PMID: 17122570BACKGROUND

  • Langeron O, Masso E, Huraux C, Guggiari M, Bianchi A, Coriat P, Riou B. Prediction of difficult mask ventilation. Anesthesiology. 2000 May;92(5):1229-36. doi: 10.1097/00000542-200005000-00009.

    PMID: 10781266BACKGROUND

  • Ramachandran SK, Kheterpal S. Difficult mask ventilation: does it matter? Anaesthesia. 2011 Dec;66 Suppl 2:40-4. doi: 10.1111/j.1365-2044.2011.06933.x.

    PMID: 22074078BACKGROUND

  • Wong E, Ng YY. The difficult airway in the emergency department. Int J Emerg Med. 2008 Jun;1(2):107-11. doi: 10.1007/s12245-008-0030-6. Epub 2008 May 29.

    PMID: 19384660BACKGROUND

  • Orebaugh SL. Difficult airway management in the emergency department. J Emerg Med. 2002 Jan;22(1):31-48. doi: 10.1016/s0736-4679(01)00435-8.

    PMID: 11809554BACKGROUND

  • Avidan MS, Zhang L, Burnside BA, Finkel KJ, Searleman AC, Selvidge JA, Saager L, Turner MS, Rao S, Bottros M, Hantler C, Jacobsohn E, Evers AS. Anesthesia awareness and the bispectral index. N Engl J Med. 2008 Mar 13;358(11):1097-108. doi: 10.1056/NEJMoa0707361.

    PMID: 18337600BACKGROUND

  • Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of obesity in the United States, 2009-2010. NCHS Data Brief. 2012 Jan;(82):1-8.

    PMID: 22617494BACKGROUND

  • Gerstein NS, Carey MC, Braude DA, Tawil I, Petersen TR, Deriy L, Anderson MS. Efficacy of facemask ventilation techniques in novice providers. J Clin Anesth. 2013 May;25(3):193-7. doi: 10.1016/j.jclinane.2012.10.009. Epub 2013 Mar 21.

    PMID: 23523573BACKGROUND

  • Fei M, Blair JL, Rice MJ, Edwards DA, Liang Y, Pilla MA, Shotwell MS, Jiang Y. Comparison of effectiveness of two commonly used two-handed mask ventilation techniques on unconscious apnoeic obese adults. Br J Anaesth. 2017 Apr 1;118(4):618-624. doi: 10.1093/bja/aex035.

    PMID: 28403406DERIVED

MeSH Terms

Conditions

Apnea

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yandong Jiang, MD, PhD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Department of Anesthesiology

Study Record Dates

First Submitted

October 16, 2015

First Posted

October 20, 2015

Study Start

September 1, 2015

Primary Completion

November 17, 2015

Study Completion

November 17, 2015

Last Updated

July 11, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)