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Intrinsic PEEP and Laryngeal Aperture in COPD

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ClinicalTrials.gov Identifier: NCT02437630
Recruitment Status : Recruiting
First Posted : May 7, 2015
Last Update Posted : June 7, 2017
Sponsor:
Information provided by (Responsible Party):
Royal Brompton & Harefield NHS Foundation Trust

Brief Summary:
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 .

Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease Procedure: Oesophageal balloon to measure intra-thoracic pressure Procedure: Fibre-optic laryngoscopy Other: standard lung function tests Procedure: face mask CPAP Procedure: variation of mouth pressure with CPAP Other: facemask pneumotachograph

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: An Investigation Into the Pressure and Airflow/Volume Changes Which Accompany Partial Closure of the Larynx During Expiration in Patients With COPD and the Effect of Applying a Positive End Expired Pressure by Facemask on These Parameters
Study Start Date : April 2016
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Group/Cohort Intervention/treatment
Patients with COPD
Patients with COPD aged >40 years with Gold stage II as measured by standard lung function testing or worse and at least 10 pack year history of smoking who will have insertion of an oesophageal balloon to measure intra-thoracic pressure, fibre-optic laryngoscopy to observe movement of the larynx during respiration and facemask pneumotachograph measurement of airflow and volumes at the mouth. The facemask which will be used to deliver a positive airway pressure (continuous positive airways pressure(CPAP) This will provide face mask CPAP with variation of mouth pressure with CPAP
Procedure: Oesophageal balloon to measure intra-thoracic pressure
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.

Procedure: Fibre-optic laryngoscopy
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.

Other: standard lung function tests
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

Procedure: face mask CPAP
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)

Procedure: variation of mouth pressure with CPAP
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.

Other: facemask pneumotachograph
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

normal subjects without copd
Subjects without COPD and normal lung function as measured by standard lung function tests who will have insertion of an oesophageal balloon to measure intra-thoracic pressure, fibre-optic laryngoscopy to observe movement of the larynx during respiration and facemask pneumotachograph measurement of airflows and volumes at the mouth which will be used to deliver a positive airway pressure (continuous positive airways pressure CPAP) This will provide face mask CPAP with variation of mouth pressure with CPAP
Procedure: Oesophageal balloon to measure intra-thoracic pressure
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.

Procedure: Fibre-optic laryngoscopy
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.

Other: standard lung function tests
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

Procedure: face mask CPAP
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)

Procedure: variation of mouth pressure with CPAP
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.

Other: facemask pneumotachograph
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




Primary Outcome Measures :
  1. We will measure glottic aperture and compare glottic aperture observed with different levels of applied EPAP (expiratory positive airway pressure)in the erect and supine positions [ Time Frame: 2 years ]
    we will measure glottic aperture and compare glottic aperture observed with different levels of applied EPAP on glottic opening in the erect and supine positions


Secondary Outcome Measures :
  1. We will measure glottic aperture and and functional lung volumes ( inspiratory capacity and functional residual capacity) in the erect and supine positions at different levels of EPAP. [ Time Frame: 2 years ]
    We will measure functional lung volumes , inspiratory capacity and functional residual capacity ,and the glottic aperture in the erect and supine positions at different levels of EPAP

  2. We will determine the effect on PEEPi of applied EPAP in the erect and supine positions [ Time Frame: 2 years ]
    We will determine the effect on PEEPi of applied EPAP in the erect and supine positions



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

20 patients with chronic obstructive pulmonary disease (COPD) Gold stage 11 as severity of disease aged 40+ male and female at least 1 pack/day of cigarettes for >10 years

10 normal subjects no evidence of Chronic obstructive pulmonary disease (COPD) on spirometry < 1 pack of cigarettes /day for 10 years age >40 male and female

Criteria

Inclusion Criteria:

  • patients with COPD
  • Gold stage 11 as severity of disease
  • aged 40+
  • male and female
  • at least 1 pack/day of cigarettes for >10 years
  • normal subjects
  • no evidence of Chronic Obstructive pulmonary disease (COPD) on spirometry
  • < 1 pack of cigarettes/day for 10 years
  • age >40
  • male and female

Exclusion Criteria:

  • an inability to comprehend what is proposed or travel to appointments
  • restrictive lung pathology as assessed by history and lung function testing
  • active infection
  • evidence of cardiac disease
  • inability to tolerate any of the following
  • the fibre-optic laryngoscope
  • the passing and retention of the oesophageal balloon
  • the wearing of a face mask
  • the application of a low level of positive pressure to the face mask and mouth ( CPAP, EPAP)
  • those who are receiving a trial drug as part of another study at the time of study
  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02437630


Contacts
Contact: michael Apps, MD =447904324578 m.apps@nhs.net
Contact: Michael Polkey, PhD ==442073518058 m.polkey@rbht.nhs.uk

Locations
United Kingdom
michael apps MD Recruiting
London, United Kingdom, SW3 6NP
Contact: michael apps, MD    447904324578    m.apps@nhs.net   
Contact: michael polkey, PhD    442073518958    m.polkey@rbht.nhs.uk   
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
Investigators
Principal Investigator: michael Polkey, PhD Royal Brompton & Harefield NHS Foundation Trust

Responsible Party: Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02437630     History of Changes
Other Study ID Numbers: RO2014LF017B
First Posted: May 7, 2015    Key Record Dates
Last Update Posted: June 7, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases