Effect of CPAP on Respiratory Load in COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Effect of CPAP on Respiratory Load and Lung Volume in Stable COPD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06390631
• Other study ID #: 2020 No.38
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: July 10, 2024

Study information

• Verified date: May 2024
• Source: State Key Laboratory of Respiratory Disease
• Contact: Yuanming Luo, PHD
• Phone: +8613570033081
• Email: yluo15[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Objective: To assess the effect of CPAP on respiratory load and lung volume in stable COPD. Methods: Patients with COPD were recruited to breath under the atmosphere pressure and different levels of CPAP (4, 6, 8 and 10 cm H2O). Diaphragm EMG, esophageal pressure (Pes) and transdiaphragmatic pressure (Pdi) were recorded using balloon esophageal electrode catheter (Yinghui, Guangzhou, China). End inspiratory lung volume (EILV) was measured directly from a pneumotachograph combined with a three way valve under the different CPAP levels. Sensation of breathing difficulty was also assessed. In an additional study, the effect of airflow on pressure was investigated by a physical mode.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 19
• Est. completion date: July 10, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Willing to participate after informed consent

2. Males and females, any race and aged 40-80 years

3. GOLD II-IV COPD (post-bronchodilator FEV1 < 80 % of the predicted normal, and a post-bronchodilator FEV1/FVC < 0.70)

Exclusion Criteria:

1. Patients recovering from acute exacerbation less than 4 weeks.

2. Patients with concomitant pulmonary disease (e.g. lung fibrosis, interstitial lung disorder).

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Continuous Positive Airway Pressure
Patients with COPD were recruited to breath under the atmosphere pressure and different levels of CPAP (4, 6, 8 and 10 cm H2O).

Locations

Country	Name	City	State
China	Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
State Key Laboratory of Respiratory Disease

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Lung volume	measurement of end inspiratory lung volume (EILV)	1-3 minutes after each CPAP level (0, 4, 6, 8 and 10 cm H2O)
Primary	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.
Primary	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.
Primary	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.
Primary	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	Respiratory rate (RR)	assessment of 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.
Secondary	Tidal volume (Vt)	assessment of tidal volume	Around 5 minutes signals under the atmosphere pressure and different levels of CPAP (4, 6, 8 and 10 cm H2O) were recorded.
Secondary	Minute ventilation (VE)	assessment of minute ventilation	Around 5 minutes signals under the atmosphere pressure and different levels of CPAP (4, 6, 8 and 10 cm H2O) were recorded.
Secondary	Peak inspiratory flow rate	assessment of 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.
Secondary	Expiratory muscle EMG	assessment of the electrical activity of the internal oblique muscle (EMG-obl) and the rectus muscle (EMG-rec)	Around 5 minutes signals under the atmosphere pressure and different levels of CPAP (4, 6, 8 and 10 cm H2O) were recorded.
Secondary	Expiratory pressure	The change in Pga resulting from the contraction of the abdominal muscles during expiration was analyzed	Around 5 minutes signals under the atmosphere pressure and different levels of CPAP (4, 6, 8 and 10 cm H2O) were recorded.