Effect of CPAP on Respiratory Load in COPD

NCT06390631 | Completed

• 1 other identifier: 2020 No.38
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Both intrinsic positive end expiratory pressure (PEEPi) and dynamic hyperinflation are considered as inspiratory loads which increase work of breathing in patients with COPD. The application of extrinsic positive end expiratory pressure (PEEPe) supplied by CPAP has been claimed to reduce inspiratory load based on change in esophageal pressure which could be significantly affected by change in lung volume and airflow. The investigator hypothesized that CPAP could increase respiratory load because it increases lung volume.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; CPAP; Diaphragm EMG

Outcome Measures

Primary Outcomes (6)

• Diaphragm EMG

  assessment of the electrical activity of the diaphragm (EMG-di)

  Around 5 minutes signals under the atmosphere pressure and different levels of CPAP (4, 6, 8 and 10 cm H2O) were recorded.

• Lung volume

  measurement of end inspiratory lung volume (EILV)

  1-3 minutes after each CPAP level (0, 4, 6, 8 and 10 cm H2O)

• Intrinsic positive end expiratory pressure (PEEPi)

  PEEPi was calculated from the negative deflection in Pes from the onset of inspiratory effort to the point of zero flow during spontaneous breathing.

  Around 5 minutes signals under the atmosphere pressure and different levels of CPAP (4, 6, 8 and 10 cm H2O) were recorded.

• Inspiratory pressure

  assessment of esophageal pressure and transdiaphragmatic pressure by caculating tidal variations in Pes (∆Pes) and Pdi (∆Pdi) relatived to initiation of effort.

  Around 5 minutes signals under the atmosphere pressure and different levels of CPAP (4, 6, 8 and 10 cm H2O) were recorded.

• Inspiratory work

  the pressure-time product of the respiratory muscles (PTPes/min) and of the diaphragm (PTPdi/min) were calculated under the Pes and Pdi versus time curve and expressed per minute.

  Around 5 minutes signals under the atmosphere pressure and different levels of CPAP (4, 6, 8 and 10 cm H2O) were recorded.

• Sensation of breathing effort

  Using questionnaire to assess the sensation of breathing effort. Sensation of breath effort of CPAP use was divided into three types corresponding to -1, 0, 1 score respectively, 0 refers to the same sensation as the feeling of breathing at the atmosphere without CPAP; 1 refers to the more difficult sensation to breath at the CPAP condition than at the atmosphere.; -1 refers to the easier sensation to breath at the CPAP condition than at the atmosphere.

  5 minutes after each CPAP level (0, 4, 6, 8 and 10 cm H2O)

Secondary Outcomes (6)

• Respiratory rate (RR)

  Around 5 minutes signals under the atmosphere pressure and different levels of CPAP (4, 6, 8 and 10 cm H2O) were recorded.

• Tidal volume (Vt)

  Around 5 minutes signals under the atmosphere pressure and different levels of CPAP (4, 6, 8 and 10 cm H2O) were recorded.

• Minute ventilation (VE)

  Around 5 minutes signals under the atmosphere pressure and different levels of CPAP (4, 6, 8 and 10 cm H2O) were recorded.

• Peak inspiratory flow rate

  Around 5 minutes signals under the atmosphere pressure and different levels of CPAP (4, 6, 8 and 10 cm H2O) were recorded.

• Expiratory muscle EMG

  Around 5 minutes signals under the atmosphere pressure and different levels of CPAP (4, 6, 8 and 10 cm H2O) were recorded.

Study Arms (1)

CPAP treatment

EXPERIMENTAL

CPAP treatment in COPD patients

Device: Continuous Positive Airway Pressure

Interventions

Continuous Positive Airway Pressure DEVICE

Patients with COPD were recruited to breath under the atmosphere pressure and different levels of CPAP (4, 6, 8 and 10 cm H2O).

CPAP treatment

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to participate after informed consent
• Males and females, any race and aged 40-80 years
• GOLD II-IV COPD (post-bronchodilator FEV1 \< 80 % of the predicted normal, and a post-bronchodilator FEV1/FVC \< 0.70)

You may not qualify if:

• Patients recovering from acute exacerbation less than 4 weeks.
• Patients with concomitant pulmonary disease (e.g. lung fibrosis, interstitial lung disorder).

Sponsors & Collaborators

• State Key Laboratory of Respiratory Disease: lead

Study Sites (1)

Guangzhou Medical University

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Yuanming Luo, PHD

  Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: CPAP treatment

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: April 30, 2024
• Study Start: May 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: July 9, 2024
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will be shared after the paper of this study publishing.
• Access Criteria: After the paper of this study publishing

Locations

CN (1)