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Influence of Neuromuscular Block on Mask Ventilation

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ClinicalTrials.gov Identifier: NCT01849211
Recruitment Status : Unknown
Verified September 2016 by Kreiskrankenhaus Dormagen.
Recruitment status was:  Recruiting
First Posted : May 8, 2013
Last Update Posted : September 7, 2016
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)
Estimated Enrollment : 250 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Influence of a Neuromuscular Block on Face Mask Ventilation Conditions During Induction of Anaesthesia
Study Start Date : April 2013
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

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



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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


Contacts
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Contact: Stefan Soltesz, MD 0049 2133 66 4500 stefan.soltesz@kkh-ne.de

Locations
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Germany
KKH Dormagen Recruiting
Dormagen, Germany, 71375
Contact: Stefan Soltesz, MD    0049 2133 66 4500    stefan.soltesz@kkh-ne.de   
Principal Investigator: Stefan Soltesz, MD         
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     History of Changes
Other Study ID Numbers: diffmask
First Posted: May 8, 2013    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: September 2016

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