NCT01849211

Brief Summary

Difficult mask ventilation might lead to a life-threatening situation, if endotracheal intubation is also impossible and neuromuscular blocking agents (NMBA) inhibit spontaneous ventilation. However, controversies exist if NMBA improve or impede face mask ventilation. Therefore, the effect of NMBAs on mask ventilation is assessed in patients with predictors for difficult face mask ventilation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 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

April 1, 2013

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

April 25, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 8, 2013

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

February 21, 2020

Status Verified

March 1, 2018

Enrollment Period

4 years

First QC Date

April 25, 2013

Last Update Submit

February 19, 2020

Conditions

Effect of a Neuromuscular Block on Ventilation

Keywords

ventilationface maskNMBA

Outcome Measures

Primary Outcomes (1)

  • minute volume

    15 min (from Induction of anaesthesia until onset of NMBA )

Secondary Outcomes (1)

  • incidence of difficult mask ventilation - tidal volume < 150 ml

    15 min

Other Outcomes (1)

  • airway pressure

    15 min

Study Arms (1)

neuromuscular block

OTHER
Drug: rocuronium

Interventions

rocuroniumDRUG
neuromuscular block

Eligibility Criteria

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

You may qualify if:

  • Patients with risk factors for difficult face mask ventilation
  • Patients scheduled for general anaesthesia with endotracheal intubation

You may not qualify if:

  • Increased Risk for pulmonary aspiration
  • scheduled for awake fiberoptic intubation
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KKH Dormagen

Dormagen, 71375, Germany

Location

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

Rocuronium

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Stefan Soltesz, MD

    KKH Dormagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2013

First Posted

May 8, 2013

Study Start

April 1, 2013

Primary Completion

April 1, 2017

Study Completion

March 1, 2018

Last Updated

February 21, 2020

Record last verified: 2018-03

Locations

DE(1)