Efficacy of an Advanced Auto-titrating NIV in COPD

Status Suspended

Clinical Trial Summary

Patients with chronic obstructive pulmonary disease (COPD) can eventually progress to respiratory failure, where they cannot adequately exchange oxygen and carbon dioxide, leading to worsening breathlessness, frequent hospitalisations and death. Non-invasive ventilation (NIV) is a ventilator therapy that is used in COPD patients who suffer from respiratory failure. Studies have demonstrated that using NIV at night regularly can result in improved clinical outcomes. Adherence to this therapy is variable, however. This can be due to poor synchrony between the device and the lungs. A novel ventilator has been designed that delivers NIV but is also incorporated with technology to assess for aberrations in respiratory physiology and correct them, breath-by-breath. The investigators aim to assess the efficacy, safety and tolerability of this novel ventilator. The primary research question is whether the novel ventilator can improve adherence to therapy, when compared with the usual ventilator. Patients with COPD who use ventilation at home will be screened for inclusion in the study. Participation will involve a screening visit, and a further two visits to the Lane Fox Respiratory Unit. The first will require a two-night admission and the second a single-night admission. They will undergo detailed assessment of their daytime and overnight respiratory and sleep physiology during these admissions. These visits will be separated by a six-week period during which they will be asked to use the novel ventilator at home. Patients will be recruited into a sub-study to evaluate the performance of the ventilator in a daytime physiological assessment. This will involve detailed invasive physiological assessment of expiratory flow limitation and how the machine is able to adjust settings to optimise respiratory support.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Chronic Obstructive Pulmonary Disease Severe
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive

Clinical Trial Details

NCT number	NCT04848012
Study type	Interventional
Source	Guy's and St Thomas' NHS Foundation Trust
Contact
Status	Suspended
Phase	N/A
Start date	May 4, 2021
Completion date	January 2025

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT03923660` - Ventilatory Adaptation to Concentric Versus Eccentric Exercise in Patients With Severe COPD	N/A
Recruiting	`NCT06008210` - A Decision Aid on End-of-life Care for Patients With Advanced COPD and Their Family	N/A
Recruiting	`NCT05029349` - Exploration of the VOLATOLOM in the Stable Severe COPD (Chronic Obstructive Pulmonary Disease)	N/A
Not yet recruiting	`NCT05539547` - Effect of NMES on Quadriceps Muscle Strength and Endurance in Patients With COPD	Early Phase 1
Recruiting	`NCT04018729` - Cell Therapy Associated With Endobronchial Valve	Phase 2/Phase 3
Recruiting	`NCT06198309` - Risk Prediction Model for Exacerbating Phenotype in Patients With Chronic Obstructive Pulmonary Disease
Recruiting	`NCT03398772` - Effects of a Comprehensive Health Coaching Program in Advanced Chronic Obstructive Pulmonary Disease.	N/A
Recruiting	`NCT06247397` - Effect of HIgh-flow Therapy in Long-term Oxygen Therapy	N/A
Completed	`NCT05259280` - Observational Study of the Wellinks Solution Impact on Quality of Life and Clinical Outcomes in Patients With COPD	N/A
Not yet recruiting	`NCT06212765` - Oral Citrulline Supplementation in COPD Patients With Malnutrition	Phase 3
Completed	`NCT02962999` - Effect Of Ketamine Infusion In Patients With COPD Applied One Lung Ventilation	Phase 4
Not yet recruiting	`NCT06229509` - Study of the Cytokine Response During Exercise Dyspnea in Patients With Chronic Obstructive Pulmonary Disease (COPD). Effect of Body Composition	N/A
Completed	`NCT05431218` - Association of Cathelicidin and Vitamin D Levels With the Category and Course of COPD	Phase 4
Recruiting	`NCT04069312` - Roflumilast or Azithromycin to Prevent COPD Exacerbations (RELIANCE)	Phase 4
Recruiting	`NCT05575336` - Assessment of the Effectiveness, Socio-economic Impact and Implementation of a Digital Solution for Severe Patients	N/A
Completed	`NCT02998515` - Effects of Different Oxygen Devices in Hypoxemic COPD Patients	N/A
Completed	`NCT04533516` - Additional Manual Therapy Over Inspiratory Muscle Training in COPD	N/A
Recruiting	`NCT06072690` - Respiratory and Cardiovascular Alterations in Patients With Chronic Obstructive Pulmonary Disease

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.