NCT05198219

Brief Summary

The aim of this study is to investigate the procedure efficiency, organisational and economic impact, and physician evaluation of the conventional reusable rhino laryngoscope vs. Ambu® aScope™ 4 RhinoLaryngo in procedures conducted distally form the ENT department e.g. in the emergency department (ED), intensive care unit (ICU), ward etc., i.e. consults.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

January 31, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

March 15, 2022

Status Verified

March 1, 2022

Enrollment Period

3 months

First QC Date

November 5, 2021

Last Update Submit

March 1, 2022

Conditions

Laryngeal Disease

Outcome Measures

Primary Outcomes (1)

  • Pre-procedure time from notification of the physician to start of rhinolaryngoscopy.

    The time (minutes) from indication of the need for a rhinolaryngoscopy, as registered by the physician until initiation of rhinolaryngoscopy. The mean time registered for the experimental arm will be compared to the active comparator arm to assess differences.

    Prior to procedure

Secondary Outcomes (16)

  • Availability assessed as the time from indication of the need of the rhinolaryngoscopy until the physician leaves to conduct the rhinolaryngoscopy.

    Prior to procedure

  • Time from indication for the need of rhinolaryngoscopy until the procedure is completed.

    Within 24 hours after completion of procedure.

  • Organisational impact - User preference for type of rhinolaryngoscope assessment of work process.

    Up to 26 weeks after study completion

  • Organisational impact - User preference for type of rhinolaryngoscope for workflow.

    Up to 26 weeks after study completion

  • Organisational impact - User evaluation for type of rhinolaryngoscope based on time until start of rhinolaryngoscopy.

    Up to 26 weeks after study completion

  • +11 more secondary outcomes

Study Arms (2)

Rhinolaryngoscope Ambu® aScope™ 4 Rhinolaryngo

EXPERIMENTAL

All approved procedures performed during the study period.

Device: Ambu® aScope™ 4 Rhinolaryngo

Conventional reusable rhinolaryngoscope

ACTIVE COMPARATOR

All procedures performed during the study period.

Device: Conventional reusable rhinolaryngoscope

Interventions

Ambu® aScope™ 4 RhinolaryngoDEVICE

Patient indication following a rhinolaryngoscopy

Rhinolaryngoscope Ambu® aScope™ 4 Rhinolaryngo
Conventional reusable rhinolaryngoscopeDEVICE

Patient indication following a rhinolaryngoscopy

Conventional reusable rhinolaryngoscope

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The investigator has been trained and conducted at least 5 successful training procedures with both the aScope 4 RhinoLaryngo and the reusable rhinolaryngoscope systems.
  • The investigator on call for consults must be available to fill out the CRF immediately before and after the procedure.
  • The investigator must be dedicated to the study while on call for consults
  • Clinical indication and eligible for a rhino laryngoscopy, as judged by the physician
  • Patients ≥18 years

You may not qualify if:

  • If the patient has no clear indication for rhino laryngoscopy the procedure should not be conducted.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ambu A/S

Ballerup Municipality, Capital Region, 2750, Denmark

RECRUITING

Related Publications (1)

  • Gudnadottir G, Hafsten L, Dahl Travis H, Nielsen K, Hellgren J. Comparison of utility and organizational impact of reusable and single-use rhinolaryngoscopes in a tertiary otorhinolaryngology department. Front Surg. 2024 Oct 7;11:1380571. doi: 10.3389/fsurg.2024.1380571. eCollection 2024.

    PMID: 39435392DERIVED

MeSH Terms

Conditions

Laryngeal Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Johan Hellgren, MD

    Sahlgrenska Universitetssjukhuset

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Su Zhang, PhD

CONTACT

+45 20930439suzh@ambu.com

Helena Travis, MSc

CONTACT

+4520679337hetr@ambu.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2021

First Posted

January 20, 2022

Study Start

January 31, 2022

Primary Completion

April 30, 2022

Study Completion

September 1, 2022

Last Updated

March 15, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)