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

State Key Laboratory of Respiratory Disease Clinical Trial

Official title:

Study of Neural Inspiratory Time and Expiratory Delay in Patients and Healthy Subjects During Unassisted Spontaneous Breathing and Mechanical Ventilation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02817035
• Other study ID #: yls2016
• Status: Completed
• Phase: N/A
• First received: June 16, 2016
• Last updated: November 13, 2016
• Start date: June 2016
• Est. completion date: November 2016

Study information

• Verified date: November 2016
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Respiration Disorders
• Respiratory Aspiration
• Respiratory Tract Diseases
• State Key Laboratory of Respiratory Disease

Intervention

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

Locations

Country	Name	City	State
China	TheFirst Affiliated Hospital Of Guangzhou Medical Collage	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neural inspiratory time	Compare the neural inspiratory time during spontaneous breathing and noninvasive mechanical ventilation.	20-30 minutes	No
Secondary	expiratory delay	to assess the expiratory delay during noninvasive mechanical ventilation	20-30 minutes	No