NCT03854968

Brief Summary

A multicentre quality control survey of home mechanical ventilation in patients. The prescribed ventilation settings, the settings of the ventilator control panel and the actual performance of the ventilator will be tested.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
147

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 26, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2019

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

1.3 years

First QC Date

February 15, 2019

Last Update Submit

August 6, 2019

Conditions

Mechanical Ventilation

Keywords

Mechanical ventilationPerformance

Outcome Measures

Primary Outcomes (1)

  • Pressure

    ventilator pressures

    20 minutes

Study Arms (1)

Quality control

EXPERIMENTAL

The participants home mechanical ventilator will be tested in order to performe a quality control

Other: Quality control

Interventions

Quality controlOTHER

The performance of the home mechanical ventilator of all patients in the study will be evaluated with a portable device

Quality control

Eligibility Criteria

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

You may qualify if:

  • Written informed consent
  • Home mechanically ventilated
  • \>18 years

You may not qualify if:

  • Pacients with servoventilation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic

Barcelona, 08036, Spain

Location

MeSH Terms

Interventions

Quality Control

Intervention Hierarchy (Ancestors)

TechnologyTechnology, Industry, and Agriculture

Study Officials

  • Josep M Montserrat, Prof

    Hospital Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 15, 2019

First Posted

February 26, 2019

Study Start

December 15, 2017

Primary Completion

April 1, 2019

Study Completion

May 20, 2019

Last Updated

August 7, 2019

Record last verified: 2019-08

Locations

ES(1)