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

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

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.

Study Overview

• Status: Completed
• Conditions: State Key Laboratory of Respiratory Disease
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • TheFirst Affiliated Hospital Of Guangzhou Medical Collage

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: noninvasive mechanical ventilation; To investigate the change of the neural inspiratory time and expiratory delay noninvasive mechanical ventilation ,in comparison to spontaneous breathing	Device: noninvasive mechanical ventilation; To examined the physiological signals of patients and healthy subjects during spontaneous breathing and noninvasive mechanical ventilation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
neural inspiratory time	Compare the neural inspiratory time during spontaneous breathing and noninvasive mechanical ventilation.	20-30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
expiratory delay	to assess the expiratory delay during noninvasive mechanical ventilation	20-30 minutes

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Guangzhou Medical University
• Investigators: Study Director: rongchang chen, MD, The First Affiliated Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: June 16, 2016
• First Submitted That Met QC Criteria: June 25, 2016
• First Posted (Estimate): June 29, 2016

Study Record Updates

• Last Update Posted (Estimate): November 15, 2016
• Last Update Submitted That Met QC Criteria: November 13, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: mechanical ventilation; interstitial lung disease; chronic obstructive pulmonary disease; expiratory delay; neural inspiratory time
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Aspiration; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: yls2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED