Study of Neural Inspiratory Time and Expiratory Delay in Patient and Health During Spontaneous Breathing and Ventilation

NCT ID: NCT02817035

Last Updated: 2016-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2016-11-30

Brief Summary

To make these definitions of neural inspiratory time (Ti) and expiratory delay clearly.The present study was undertaken to examined the physiological signals of patients and healthy subjects during spontaneous breathing and noninvasive mechanical ventilation.

Detailed Description

In total, 8 chronic obstructive pulmonary disease (COPD) patients, 8 patients with interstitial lung disease (ILD) and 8 healthy subjects were recruited.

The patient was studied at the afternoon in a semirecumbent position. After the application of topical anaesthesia (2% xylocaine), the patient was asked to swallow two balloon-tipped catheters and the multi-pair esophageal electrode catheter through the nose into the their right position.

At the first period, the stable signals of unassisted spontaneous breathing (about 5min) were chosen to be recorded. After this period, the patient was placed on noninvasive pressure support ventilation(PSV). The inspiratory positive airway pressure (IPAP) was initially titrated by patient's tolerance . The noninvasive ventilation lasted at least 20 minutes until the breathing was stable. All the raw signals were recorded. The last 15 minutes of the stable computer-stored data were calculated and analyzed. The leaks were monitored by the display of the ventilator and the computer during the procedure. When the leak was observed, the mask was carefully adjusted to prevent. Esophageal and gastric balloon-catheters were used to detect the intra-thoracic and abdominal pressure. Airway pressure was also measured simultaneously. EMGdi was recorded from a multipair esophageal electrode .During ventilation Airflow and ventilation were measured with pneumotachograph.

Respiratory rate, tidal volume,the time difference between the initial increase and the termination of the diaphragm electromyogram(EMGdi) , time difference between maximal value of EMGdi and the end of inspiratory flow,time difference between the point of zero flow between inspiration and expiration ,and the time difference between the onset of the upward deflection in transdiagramic pressure( Pdi) and the return of Pdi were calculated during the unassisted spontaneous breathing and mechanical ventilation.

Conditions

State Key Laboratory of Respiratory Disease

Keywords

interstitial lung disease; chronic obstructive pulmonary disease; mechanical ventilation; expiratory delay; neural inspiratory time

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

noninvasive mechanical ventilation

To investigate the change of the neural inspiratory time and expiratory delay noninvasive mechanical ventilation ,in comparison to spontaneous breathing

Group Type: EXPERIMENTAL

noninvasive mechanical ventilation

Intervention Type: DEVICE

To examined the physiological signals of patients and healthy subjects during spontaneous breathing and noninvasive mechanical ventilation.

Interventions

noninvasive mechanical ventilation

To examined the physiological signals of patients and healthy subjects during spontaneous breathing and noninvasive mechanical ventilation.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. chronic obstructive pulmonary disease patient meet the diagnose criteria of chronic obstructive pulmonary disease

2. interstitial lung disease patient meet the diagnose criteria of interstitial lung disease

3. healthy subjects No history of the lung and Cardiovascular disease.The lung function is normal.

Exclusion Criteria

1. severe Cardiovascular disease

2. Pneumonia

3. neuromuscular and chest wall deformity

4. Respiratory arrest

5. Cardiovascular instability (hypotension, arrhythmias, myocardial infarction)

6. Change in mental status; uncooperative patient

7. High aspiration risk

8. Viscous or copious secretions

9. Recent facial or gastroesophageal surgery

10. Craniofacial trauma

11. Fixed nasopharyngeal abnormalities

12. Burns

13. Extreme obesity

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Zhang Jianheng

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

rongchang chen, MD

Role: STUDY_DIRECTOR

The First Affiliated Hospital of Guangzhou Medical University

Locations

TheFirst Affiliated Hospital Of Guangzhou Medical Collage

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

yls2016

Identifier Type: -

Identifier Source: org_study_id