NCT03741049

Brief Summary

During a cannot ventilate cannot intubate situation surgical airway is the last rescue option. Especially in the prehospital setting the airway management seems to be more difficult than in a hospital setting. Nearly all emergency physicians have a limited experience with cricothyrotomy and it is a unclear what method should be taught for this lifesaving procedure, due to lack of data in humans. The aim of this study is to compare the performance of medical personnel (medical students, paramedics, trainee anaesthetists and consultants) in establishing an emergency surgical airway on a plastic laryngeal model and in a porcine laryngeal model using the Scalpel Bougie technique, the Seldinger technique and the common surgical technique. Furthermore the investigators want to elucidate whether the training of the 3 techniques has an influence in the decision making of the preferred technique in a subsequently simulated cannot ventilate cannot intubate scenario.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

November 13, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2018

Completed
Last Updated

February 19, 2019

Status Verified

February 1, 2019

Enrollment Period

1 month

First QC Date

November 8, 2018

Last Update Submit

February 16, 2019

Conditions

Cricothyroidotomy

Keywords

CVCIEmergency medicineAirway managementCricothyroidotomy

Outcome Measures

Primary Outcomes (1)

  • Time from initially handling equipment to a successful placement of the endotracheal tube verified by a fiberoptic position check

    up to 3 minutes

Secondary Outcomes (6)

  • Success rate in the first trial

    up to 3 minutes

  • Number of trials

    up to 3 minutes

  • Dimension of the tracheal trauma

    up to 10 minutes

  • Comfort evaluation by the performer

    up to 15 minutes

  • Influence of training on the time to decision making for cricothyrotomy

    up to 5 hours

  • +1 more secondary outcomes

Study Arms (4)

Consultants

Device: Scalpel Bougie technique (plastic laryngeal model)Device: Seldinger technique (plastic laryngeal model)Device: Surgical technique (plastic laryngeal model)Device: Scalpel Bougie technique (porcine laryngeal model)Device: Surgical technique (porcine laryngeal model)

Trainee anaesthetists

Device: Scalpel Bougie technique (plastic laryngeal model)Device: Seldinger technique (plastic laryngeal model)Device: Surgical technique (plastic laryngeal model)Device: Scalpel Bougie technique (porcine laryngeal model)Device: Surgical technique (porcine laryngeal model)

Paramedics

Device: Scalpel Bougie technique (plastic laryngeal model)Device: Seldinger technique (plastic laryngeal model)Device: Surgical technique (plastic laryngeal model)

Students

Device: Scalpel Bougie technique (plastic laryngeal model)Device: Seldinger technique (plastic laryngeal model)Device: Surgical technique (plastic laryngeal model)

Interventions

Scalpel Bougie technique (plastic laryngeal model)DEVICE

ScalpelBougie Set

ConsultantsParamedicsStudentsTrainee anaesthetists
Seldinger technique (plastic laryngeal model)DEVICE

Melker Set

ConsultantsParamedicsStudentsTrainee anaesthetists
Surgical technique (plastic laryngeal model)DEVICE

Scalpel and speculum

ConsultantsParamedicsStudentsTrainee anaesthetists
Scalpel Bougie technique (porcine laryngeal model)DEVICE

ScalpelCric Set

ConsultantsTrainee anaesthetists
Surgical technique (porcine laryngeal model)DEVICE

Scalpel and speculum

ConsultantsTrainee anaesthetists

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Medical students (University Mainz), paramedics (DRK, MHD, ASB, ADAC), trainee anaesthetists and consultants (Department of anaesthesiology University hospital Mainz)

You may qualify if:

  • written informed consent
  • German language in speaking and writing
  • Capability of giving consent

You may not qualify if:

  • Participants unwilling or unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johannes Gutenberg University Medicine Centre Mainz

Mainz, Rhineland Palatine, 55131, Germany

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 8, 2018

First Posted

November 14, 2018

Study Start

November 13, 2018

Primary Completion

December 20, 2018

Study Completion

December 20, 2018

Last Updated

February 19, 2019

Record last verified: 2019-02

Locations

DE(1)