NCT01932567

Brief Summary

To compare the effect of different airway clearance techniques on lung ventilation by electrical impedance tomography.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

August 1, 2013

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 30, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Last Updated

July 24, 2014

Status Verified

July 1, 2014

Enrollment Period

11 months

First QC Date

August 19, 2013

Last Update Submit

July 23, 2014

Conditions

Respiratory Disease

Outcome Measures

Primary Outcomes (1)

  • Regional lung ventilation measured by Electrical impedance tomography

    Recording by electrical impedance tomography will be performed during 30 minutes

Study Arms (3)

Positive expiratory pressure

EXPERIMENTAL

Use of positive expiratory pressure during 3 minutes

Other: PhysiotherapyProcedure: Electrical impedance tomography

Incentive spirometry

EXPERIMENTAL

Use of incentive spirometry during 3 minutes

Other: PhysiotherapyProcedure: Electrical impedance tomography

manual airway clearance technique

EXPERIMENTAL

Use of manual airway clearance technique during 3 minutes

Other: PhysiotherapyProcedure: Electrical impedance tomography

Interventions

PhysiotherapyOTHER
Incentive spirometryPositive expiratory pressuremanual airway clearance technique
Electrical impedance tomographyPROCEDURE
Incentive spirometryPositive expiratory pressuremanual airway clearance technique

Eligibility Criteria

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

You may qualify if:

  • \>18 years old
  • Surgery under anesthesia (PEP and incentive spirometry) or healthy subjects
  • Intervention time before first bed lift
  • Cooperative
  • Can perform devices techniques correctly

You may not qualify if:

  • Patients with pacemaker, implantable pumps or automatic implantable cardioverter defibrillator
  • Patients with pulmonary disease (acute or chronic)
  • Patients with cognitive problems
  • Presence of patches or wounds in EIT belt zone placement
  • Patients with initial pain \> 2/10
  • Patients with severe obesity (BMI \> 35)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinique universitaire Saint-Luc

Brussels, Belgium

RECRUITING

Cliniques universitaires Saint-Luc

Brussels, Belgium

RECRUITING

MeSH Terms

Conditions

Respiration Disorders

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Central Study Contacts

Coralie Colbrant, PT

CONTACT

colbrant.coralie@hotmail.com

Jean Roeseler

CONTACT

jean.roeseler@uclouvain.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

August 19, 2013

First Posted

August 30, 2013

Study Start

August 1, 2013

Primary Completion

July 1, 2014

Last Updated

July 24, 2014

Record last verified: 2014-07

Locations

BE(2)