NCT03373175

Brief Summary

Evaluation of high intensity NIMV in terms of physiological parameters has been performed in short-term studies in COPD patients. However, the support pressure levels used in exacerbated patients seem contradictory and the muscular unloading levels are uncertain. The objective of study is to determine the discharge level of the inspiratory musculature reached at the same pressure support (PS) values in a group of hospital and domiciliary ventilators. Patients with COPD in at least 6 months of treatment with home NIMV and in stable phase of their disease will be included. Eight commercial ventilators will be used, each patient will use 2 different ventilators. A 5 minute record will be taken at baseline (without NIMV). Subsequently, 5 minutes in NIMV in 3 levels of PS (15/10/20) for each ventilator (15/10/20) and patient with expiratory positive airway pressure (EPAP) of 5 centimeters of water (cmH2O) will be recorded. The results will be compared between the different ventilators and PS values using a general linear model for repeated variables to determine the differences between ventilators and PS levels of respiratory muscular unloading in COPD patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

November 30, 2017

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 11, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 14, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2021

Completed
Last Updated

August 4, 2021

Status Verified

August 1, 2021

Enrollment Period

2.9 years

First QC Date

December 11, 2017

Last Update Submit

August 3, 2021

Conditions

COPD

Keywords

Monitoring NIV, inspiratory muscular unloading, EMG

Outcome Measures

Primary Outcomes (1)

  • Inspiratory muscular unloading (µv)

    Differences in parasternal electromyogram (EMG) signals interpretation between the record of ventilator 1 and ventilator 2.

    1 day

Secondary Outcomes (7)

  • Baseline EMG (µv) record

    1 day

  • Pressure support 10 EMG (µv) record. V1

    1 day

  • Pressure support 15 EMG (µv) record. V1

    1 day

  • Pressure support 20 EMG (µv) record. V1

    1 day

  • Pressure support 10 EMG (µv) record. V2

    1 day

  • +2 more secondary outcomes

Study Arms (4)

Ventilator 1 vs Ventilator 2

EXPERIMENTAL

2 Ventilators will be evaluated for patient. All parameters will be monitored and the differences will be analyzed. Interventions: Basal record Pressure Support 10 (PS 10)record Pressure Support 15 (PS 15) record Pressure Support 20 (PS 20) record

Device: Basal recordDevice: PS 10 recordDevice: PS 15 recordDevice: PS 20 record

Ventilator 3 vs Ventilator 4

EXPERIMENTAL

2 Ventilators will be evaluated for patient. All parameters will be monitored and the differences will be analyzed.Interventions: Basal record PS10 record PS15 record PS 20 record

Device: Basal recordDevice: PS 10 recordDevice: PS 15 recordDevice: PS 20 record

Ventilator 5 vs Ventilator 6

EXPERIMENTAL

2 Ventilators will be evaluated for patient. All parameters will be monitored and the differences will be analyzed. Interventions: Basal record PS10 record PS15 record PS 20 record

Device: Basal recordDevice: PS 10 recordDevice: PS 15 recordDevice: PS 20 record

Ventilator 7 vs Ventilator 8

EXPERIMENTAL

2 Ventilators will be evaluated for patient. All parameters will be monitored and the differences will be analyzed. Interventions: Basal record PS10 record PS15 record PS 20 record

Device: Basal recordDevice: PS 10 recordDevice: PS 15 recordDevice: PS 20 record

Interventions

Basal recordDEVICE

Basal EMG record will be performed during 5 minutes. This record must be the same in both ventilators.

Ventilator 1 vs Ventilator 2Ventilator 3 vs Ventilator 4Ventilator 5 vs Ventilator 6Ventilator 7 vs Ventilator 8
PS 10 recordDEVICE

PS 10 EMG record record will be performed during 5 minutes. First with ventilator 1 and then with the other. The patient must be rest at least 5 minutes to recover basal record

Ventilator 1 vs Ventilator 2Ventilator 3 vs Ventilator 4Ventilator 5 vs Ventilator 6Ventilator 7 vs Ventilator 8
PS 15 recordDEVICE

PS 15 EMG record record will be performed during 5 minutes. First with ventilator 1 and then with the other. The patient must be rest at least 5 minutes to recover basal record

Ventilator 1 vs Ventilator 2Ventilator 3 vs Ventilator 4Ventilator 5 vs Ventilator 6Ventilator 7 vs Ventilator 8
PS 20 recordDEVICE

PS 20 EMG record record will be performed during 5 minutes. First with ventilator 1 and then with the other. The patient must be rest at least 5 minutes to recover basal record

Ventilator 1 vs Ventilator 2Ventilator 3 vs Ventilator 4Ventilator 5 vs Ventilator 6Ventilator 7 vs Ventilator 8

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with COPD diagnoses based on a spirometry performed the previous year during stability.
  • COPD patients with home NIV treatment of at least 6 months with acceptable compliance and adaptation.
  • Stable patients or just before hospital discharge due to an exacerbation with gasometric stability.

You may not qualify if:

  • Respiratory acidosis in blood gas analysis, just in case of recent exacerbation
  • Patients with restrictive pathology and /or obesity (IMC\>35)
  • Poor quality of EMG signals.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Parc Tauli

Sabadell, Barcelona, 08208, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Related Publications (1)

  • Lalmolda C, Florez P, Corral M, Hernandez Voth A, Grimau C, Sayas J, Lujan M. Does the Efficacy of High Intensity Ventilation in Stable COPD Depend on the Ventilator Model? A Bench-to-Bedside Study. Int J Chron Obstruct Pulmon Dis. 2022 Jan 14;17:155-164. doi: 10.2147/COPD.S327994. eCollection 2022.

    PMID: 35058690DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Manel Lujan, MD

    Corporacion Parc Tauli (Sabadell, Barcelona)

    PRINCIPAL INVESTIGATOR

  • Javier Sayas

    Hospital Universitario 12 de Octubre (Madrid)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 11, 2017

First Posted

December 14, 2017

Study Start

November 30, 2017

Primary Completion

October 30, 2020

Study Completion

May 3, 2021

Last Updated

August 4, 2021

Record last verified: 2021-08

Locations

ES(2)