Influence of Neuromuscular Block on Mask Ventilation | NCT01849211

Studies
Influence of Neuromuscular Block on Mask Ventilation

NCT01849211

Sponsor

Kreiskrankenhaus Dormagen

Status

Completed

Last Update Posted

Feb 21, 2020Actual

Enrollment

120Actual

Phase

Not Applicable

Conditions

Effect of a Neuromuscular Block on Ventilation

Interventions

rocuronium

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Apr 2017Actual

Completion Date

Mar 2018Actual

First Submitted Date

Apr 25, 2013

First Submission Date that Met QC Criteria

May 7, 2013

First Posted Date

May 8, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 19, 2020

Last Update Posted Date

Feb 21, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Label	Type	Description	Intervention Names
neuromuscular block	Other		Drug: rocuronium

Name	Type	Description	Arm Group Labels	Other Names
rocuronium	Drug		neuromuscular block

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stefan Soltesz, MD	KKH Dormagen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
KKH Dormagen		Dormagen		71375	Germany

Condition Browse Module

MeSH Terms

ID	Term
D053120	Respiratory Aspiration

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077123	Rocuronium

Ancestor Terms

ID	Term
D000732	Androstanols
D000731	Androstanes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided