Clinical trial NCT02817035: Study of Neural Inspiratory Time and Expiratory Delay in Patient and Health During Spontaneous Breathing and Ventilation
Official title: Study of Neural Inspiratory Time and Expiratory Delay in Patients and Healthy Subjects During Unassisted Spontaneous Breathing and Mechanical Ventilation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: State Key Laboratory of Respiratory Disease
Keywords: interstitial lung disease
chronic obstructive pulmonary disease
mechanical ventilation
expiratory delay
neural inspiratory time
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

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.

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

Primary outcomes:
measure: neural inspiratory time
timeFrame: 20-30 minutes
Secondary outcomes:
measure: expiratory delay
timeFrame: 20-30 minutes
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: TheFirst Affiliated Hospital Of Guangzhou Medical Collage
state: Guangdong
Study officials:
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: rongchang chen, MD
role: STUDY_DIRECTOR
References: