NCT02450279

Brief Summary

Many devices are available for nebulising drug solution during invasive mechanical ventilation. Vibrating-mesh nebulizers ensure the highest lung deposition output. A recent international survey on aerosol therapy during mechanical ventilation (Ehrmann et al. 2013) reported that jet nebulizers remained the mostly used. The aim of this study is to compare lung deposition of a radiolabeled administered with both nebulizers during invasive mechanical ventilation by planar scintigraphy.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

May 18, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 21, 2015

Completed
10 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2017

Completed
Last Updated

November 8, 2017

Status Verified

December 1, 2016

Enrollment Period

1.7 years

First QC Date

May 18, 2015

Last Update Submit

November 7, 2017

Conditions

Post-operative Neurosurgery

Keywords

Aerosol deliveryInvasive mechanical ventilationJet NebulizerVibrating-Mesh nebulizer

Outcome Measures

Primary Outcomes (1)

  • Pulmonary deposition

    Immediately after nebulization by imaging assessment, an expected average of 30 minutes

Secondary Outcomes (3)

  • Penetration index

    Immediately after nebulization by imaging assessment, an expected average of 30 minutes

  • Mechanical ventilation settings

    During nebulisation time, an expected average of 15 minutes

  • Lung function

    Preoperative assessment, the day before inclusion

Study Arms (2)

Nebulization with a vibrating-mesh nebulizer

ACTIVE COMPARATOR

Nebulization performed with a vibrating-mesh nebulizer

Drug: technetium-99m - Diethylenetriaminepentaacetic acidDevice: Vibrating-mesh nebulizerOther: Planar scintigraphyOther: Preoperative spirometry

Nebulization with a jet nebulizer

ACTIVE COMPARATOR

Nebulization performed with a jet nebulizer

Drug: technetium-99m - Diethylenetriaminepentaacetic acidDevice: Jet NebulizerOther: Planar scintigraphyOther: Preoperative spirometry

Interventions

technetium-99m - Diethylenetriaminepentaacetic acidDRUG
Nebulization with a jet nebulizerNebulization with a vibrating-mesh nebulizer
Vibrating-mesh nebulizerDEVICE
Nebulization with a vibrating-mesh nebulizer
Jet NebulizerDEVICE
Nebulization with a jet nebulizer
Planar scintigraphyOTHER
Nebulization with a jet nebulizerNebulization with a vibrating-mesh nebulizer
Preoperative spirometryOTHER
Nebulization with a jet nebulizerNebulization with a vibrating-mesh nebulizer

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Invasive mechanical ventilation
  • Healthy lungs

You may not qualify if:

  • Discontinued procedure due to adverse events.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Location

Study Officials

  • Pierre-François Laterre

    Head of Intensive Care Unit, Cliniques Universitaires Saint-Luc

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2015

First Posted

May 21, 2015

Study Start

March 1, 2016

Primary Completion

November 7, 2017

Last Updated

November 8, 2017

Record last verified: 2016-12

Locations

BE(1)