Influence of Neuromuscular Block on Mask Ventilation

February 19, 2020 updated by: Kreiskrankenhaus Dormagen

Influence of a Neuromuscular Block on Face Mask Ventilation Conditions During Induction of Anaesthesia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Dormagen, Germany, 71375
        • KKH Dormagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: neuromuscular block
Drug: rocuronium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
minute volume
Time Frame: 15 min (from Induction of anaesthesia until onset of NMBA )
15 min (from Induction of anaesthesia until onset of NMBA )

Secondary Outcome Measures

Outcome Measure
Time Frame
incidence of difficult mask ventilation - tidal volume < 150 ml
Time Frame: 15 min
15 min

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
airway pressure
Time Frame: 15 min
measurement of peak airway pressure
15 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kreiskrankenhaus Dormagen

Investigators

  • Principal Investigator: Stefan Soltesz, MD, KKH Dormagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

April 25, 2013

First Submitted That Met QC Criteria

May 7, 2013

First Posted (Estimate)

May 8, 2013

Study Record Updates

Last Update Posted (Actual)

February 21, 2020

Last Update Submitted That Met QC Criteria

February 19, 2020

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • diffmask

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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