Mask Ventilation Before and After Neuromuscular Blockade

NCT02237443 | Completed Phase 4

• 1 other identifier: 40262-D
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

Anesthesia providers are taught to "test" that they can properly ventilate a patient's lungs before administering a neuromuscular blocking drug (NMBD), rendering the patient apneic. This is a traditional teaching, not based on empirical evidence. The investigators primary hypothesis is that ventilation after the administration of NMBDs is non-inferior with that before their administration with respect to the composite safety endpoint of inadequate (MVi) and dead-space only (Vds) ventilation.

Conditions

Anesthesia

Keywords

Patient Safety

Outcome Measures

Primary Outcomes (1)

• Average exhaled title volumes

  The difference in average exhaled volumes per breath between study periods before and after neuromuscular blocker administration.

  2 minutes

Secondary Outcomes (4)

• Minute ventilation (VE)

  2 minutes

• Warter's scale

  2 minutes

• Han's scale

  2 minutes

• Composite of difficult/impossible mask ventilation

  2 minutes

Study Arms (1)

Post-induction

OTHER

Anesthesia is induced with propofol and mask ventilation is commenced after patient is unresponsive to a jaw thrust prior to administration of rocuronium, vecuronium bromide, or succinylcholine

Drug: Rocuronium; Drug: Vecuronium Bromide; Drug: Succinylcholine

Interventions

Rocuronium DRUG

Administration of a NMBD

Post-induction

Vecuronium Bromide DRUG

Administration of a NMBD

Also known as: Vecuronium

Post-induction

Succinylcholine DRUG

Administration of a NMBD

Also known as: Sux

Post-induction

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are 18 years or greater
• Present for elective surgery and
• Require placement of a breathing tube for their surgery

You may not qualify if:

• Patients will not be eligible if they are pregnant
• Are a minor
• Are a prisoner
• Have impaired decision-making capacity
• Have symptomatic untreated reflux
• Prior esophagectomy or hiatal hernia
• Vomiting within 24 hours of surgery
• Known oral or facial pathology making a proper mask fit unlikely
• Any condition for which the primary anesthesia team deems a rapid-sequence intubation to be appropriate
• Prior allergy or contraindication to receiving rocuronium, vecuronium, or succinylcholine.

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Related Publications (1)

• Joffe AM, Ramaiah R, Donahue E, Galgon RE, Thilen SR, Spiekerman CF, Bhananker SM. Ventilation by mask before and after the administration of neuromuscular blockade: a pragmatic non-inferiority trial. BMC Anesthesiol. 2015 Oct 6;15:134. doi: 10.1186/s12871-015-0111-z.

  PMID: 26444853 DERIVED

MeSH Terms

Interventions

Rocuronium; Vecuronium Bromide; Succinylcholine

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Choline; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Succinates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Onium Compounds

Study Officials

• Aaron M Joffe, DO

  University of Washington Department of Anesthesiology and Pain Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Anesthesiology & Pain Medicine

Study Record Dates

• First Submitted: August 28, 2014
• First Posted: September 11, 2014
• Study Start: August 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: February 1, 2015
• Last Updated: April 9, 2015

Record last verified: 2015-04

Locations

US (1)