Effect of a Neuromuscular Block on VentilationNCT01849211
Influence of Neuromuscular Block on Mask Ventilation
A study testing rocuronium in people with Effect of a Neuromuscular Block on Ventilation, run by Kreiskrankenhaus Dormagen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Effect of a Neuromuscular Block on Ventilation
- What is being tested?
- rocuronium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2013to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with risk factors for difficult face mask ventilation
- Patients scheduled for general anaesthesia with endotracheal intubation
Who cannot join
- Increased Risk for pulmonary aspiration
- scheduled for awake fiberoptic intubation
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- rocuronium
- Keywords
- ventilation, face mask, NMBA
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rocuroniumDrug
| Study group | Role | What they receive |
|---|---|---|
| neuromuscular block | Other | Not described Receives: Drug: rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
minute volume
Measured: 15 min (from Induction of anaesthesia until onset of NMBA )
Secondary outcomes (1)
incidence of difficult mask ventilation - tidal volume < 150 ml
Measured: 15 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of a Neuromuscular Block on VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kreiskrankenhaus Dormagen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Soltesz, MD, Principal investigator, KKH Dormagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01849211
- Sponsor's protocol ID
- diffmask
- Status last verified
- Mar 2018
- First submitted
- 25 Apr 2013
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of a Neuromuscular Block on Face Mask Ventilation Conditions During Induction of Anaesthesia
- ClinicalTrials.gov ID
- NCT01849211
- Acronym / sponsor ID
- diffmask
- Keywords
- ventilation, face mask, NMBA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Kreiskrankenhaus DormagenUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Apr 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 8 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neuromuscular block | Other | Drug: rocuronium |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with risk factors for difficult face mask ventilation
- Patients scheduled for general anaesthesia with endotracheal intubation
Key exclusion criteria (3 listed)
- Increased Risk for pulmonary aspiration
- scheduled for awake fiberoptic intubation
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rocuronium | Drug | neuromuscular block |
Primary outcome
minute volume
Time frame: 15 min (from Induction of anaesthesia until onset of NMBA )
1 secondary outcome
incidence of difficult mask ventilation - tidal volume < 150 ml
Time frame: 15 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
Related trials for Effect of a Neuromuscular Block on Ventilation
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Not yet recruitingPhase 4
Fentanyl and Rocuronium for Tracheal Intubation in Newborns
Infant, Premature, Intubation, Intratracheal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Soltesz, MD principal investigator
KKH Dormagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rocuronium in people with Effect of a Neuromuscular Block on Ventilation, run by Kreiskrankenhaus Dormagen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
minute volume (time frame: 15 min (from Induction of anaesthesia until onset of NMBA )). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2020.