Effect of Ventilation Mode on Lung Deposition of a Radiolabeled Aerosol During Mechanical Ventilation: Barometric Versus Volumetric
1 other identifier
interventional
19
1 country
1
Brief Summary
Controlling the respiratory pattern of mechanically ventilated patients in volume control mode is recommended during nebulization. No studies looked into conditions of nebulization during assisted mechanical ventilation to define the optimal nebulization technique and its effect on pulmonary deposition. The aim of this study is to analyse the effect of ventilation mode (barometric versus volumetric) on deposition by planar scintigraphy during mechanical ventilation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2013
Typical duration for not_applicable
1 active site
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
June 10, 2013
CompletedFirst Posted
Study publicly available on registry
June 17, 2013
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedNovember 17, 2015
November 1, 2015
1.9 years
June 10, 2013
November 16, 2015
Conditions
Keywords
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 during pressure support ventilation
ACTIVE COMPARATORPatients ventilated in pressure support mode during nebulization
Nebulization during volume assist control mode
ACTIVE COMPARATORPatients ventilated in volume assist control mode during nebulization
Interventions
Eligibility Criteria
You may qualify if:
- Invasive mechanical ventilation
- Healthy lungs
You may not qualify if:
- Change of ventilation mode during nebulization
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
Related Publications (1)
Dugernier J, Reychler G, Wittebole X, Roeseler J, Depoortere V, Sottiaux T, Michotte JB, Vanbever R, Dugernier T, Goffette P, Docquier MA, Raftopoulos C, Hantson P, Jamar F, Laterre PF. Aerosol delivery with two ventilation modes during mechanical ventilation: a randomized study. Ann Intensive Care. 2016 Dec;6(1):73. doi: 10.1186/s13613-016-0169-x. Epub 2016 Jul 22.
PMID: 27447788DERIVED
Study Officials
- STUDY CHAIR
Pierre-François Laterre
Head of Intensive Care Unit, Cliniques Universitaires Saint-Luc
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
June 10, 2013
First Posted
June 17, 2013
Study Start
July 1, 2013
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
November 17, 2015
Record last verified: 2015-11