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Influence of Neuromuscular Block on Mask Ventilation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01849211
Recruitment Status : Completed
First Posted : May 8, 2013
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
Kreiskrankenhaus Dormagen

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.

Condition or disease Intervention/treatment Phase
Effect of a Neuromuscular Block on Ventilation Drug: rocuronium Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Influence of a Neuromuscular Block on Face Mask Ventilation Conditions During Induction of Anaesthesia
Study Start Date : April 2013
Actual Primary Completion Date : April 2017
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
neuromuscular block Drug: rocuronium



Primary Outcome Measures :
  1. minute volume [ Time Frame: 15 min (from Induction of anaesthesia until onset of NMBA ) ]

Secondary Outcome Measures :
  1. incidence of difficult mask ventilation - tidal volume < 150 ml [ Time Frame: 15 min ]

Other Outcome Measures:
  1. airway pressure [ Time Frame: 15 min ]
    measurement of peak airway pressure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01849211


Locations
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Germany
KKH Dormagen
Dormagen, Germany, 71375
Sponsors and Collaborators
Kreiskrankenhaus Dormagen
Investigators
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Principal Investigator: Stefan Soltesz, MD KKH Dormagen
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Responsible Party: Kreiskrankenhaus Dormagen
ClinicalTrials.gov Identifier: NCT01849211    
Other Study ID Numbers: diffmask
First Posted: May 8, 2013    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: March 2018
Keywords provided by Kreiskrankenhaus Dormagen:
ventilation
face mask
NMBA
Additional relevant MeSH terms:
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Rocuronium
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs