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Contact Information:

Michael Polkey, PhD ==442073518058
m.polkey@rbht.nhs.uk


michael Apps, MD =447904324578
m.apps@nhs.net


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Be Part of Research - Trial Details - Intrinsic PEEP and Laryngeal Aperture in COPD
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Intrinsic PEEP and Laryngeal Aperture in COPD

Not Recruiting

Open to: ALL

Age: 40.0 - 80.0

London

Medical Conditions

Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


In this study the investigators aim to investigate the extent to which in patients with chronic obstructive pulmonary disease narrowing of the vocal cords causes a positive pressure within the airways thus improving airflow and lung function. This information will be captured in the upright and lying down positions and an estimate of the magnitude of the effect will be formed by offsetting the pressure by asking the patients to breathe using a commercially available device used to treat sleep apnoea called a CPAP machine. This is an observational study in which the observation of laryngeal aperture, and mouth and oesophageal pressure at differing levels of applied CPAP will be recorded for analysis in patients with COPD and in normal subjects without COPD. All will have the same measurements, observations, and interventions to allow us to observe and measure pressure, laryngeal aperture, and airflow .

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Apr 2016 May 2018

OBSERVATIONAL

Intervention Type : PROCEDURE
Intervention Description : An oesophageal balloon will be inserted via a nostril after instillation of local anaesthetic and swallowed until the tip is in the lower third of the oesophagus. This will allow the intrathoracic pressure to be monitored via a pressure sensor attached to the oesophageal balloon catheter and placed next to the subject. This will allow us to observe the changes in oesophageal pressure during quiet breathing under a variety of applied positive pressure conditions.

Intervention Arm Group : Patients with COPD;normal subjects without copd;

Intervention Type : PROCEDURE
Intervention Description : A fibre-optic laryngoscope will be inserted through the opposite nostril to that used for the oesophageal balloon and placed with its tip abve the larynx where the laryngeal movement can be observed This will allow us to observe the changes in laryngeal aperture under a variety of applied positive pressure conditions.

Intervention Arm Group : Patients with COPD;normal subjects without copd;

Intervention Type : OTHER
Intervention Description : These will be carried out in any subject who has not had lung function testing in the previous 6 weeks and will be carried out by a lung function physiologist from the institution in accordance with standard procedures for lung function testing

Intervention Arm Group : Patients with COPD;normal subjects without copd;

Intervention Type : PROCEDURE
Intervention Description : The subjects will wear a facemask with apertures for the oesophageal balloon and fibre-optic devices to cover the mouth and nose. airflow and volume will be recorded with a pneumotachograph and there will be tubing to connect to a positive pressure source (CPAP) to allow mouth pressures to be altered between 0-15cm H20.( 1cm H20 is the pressure produced by a column of water of 1centimetre in depth)

Intervention Arm Group : Patients with COPD;normal subjects without copd;

Intervention Type : PROCEDURE
Intervention Description : Once the other procedures are completed the subject will have his mouth pressure varied via application of positive pressure via a commercial CPAP device as used for treatment of obstructive sleep apnoea. The pressure will be varied randomly between 0-15cm H2O (water)for periods of 5 minutes both sitting and lying. Oesophageal balloon recording of intra-thoracic pressure and laryngeal movement and mouth airflow and volume will be recorded simultaneously and at the end of each 5 minute period the subject will be requested to take as big a breath in as possible to allow measurement of functional residual capacity and inspiratory capacity. This will allow us to observe the effect of changing mouth pressure with CPAP on laryngeal aperture and oesophageal pressures and airflow.

Intervention Arm Group : Patients with COPD;normal subjects without copd;

Intervention Type : OTHER
Intervention Description : The facemask will incorporate a pneumotachograph to allow measurement of airflow and volumes throughout the respiratory cycle. This will allow us to observe the pattern of airflow with varying applied CPAP

Intervention Arm Group : Patients with COPD;normal subjects without copd;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • michael apps MD
    London
    SW3 6NP

michael Apps, MD =447904324578
m.apps@nhs.net


Michael Polkey, PhD ==442073518058
m.polkey@rbht.nhs.uk



The study is sponsored by Royal Brompton & Harefield NHS Foundation Trust



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Read full details for Trial ID: NCT02437630
Last updated 06 June 2017

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