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NCT Number: NCT02817035

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

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

TheFirst Affiliated Hospital Of Guangzhou Medical Collage

Guangzhou, Guangdong, 510000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • chronic obstructive pulmonary disease patient meet the diagnose criteria of chronic obstructive pulmonary disease
  • interstitial lung disease patient meet the diagnose criteria of interstitial lung disease
  • healthy subjects No history of the lung and Cardiovascular disease.The lung function is normal.

Exclusion criteria

  • severe Cardiovascular disease
  • Pneumonia
  • neuromuscular and chest wall deformity
  • Respiratory arrest
  • Cardiovascular instability (hypotension, arrhythmias, myocardial infarction)
  • Change in mental status; uncooperative patient
  • High aspiration risk
  • Viscous or copious secretions
  • Recent facial or gastroesophageal surgery
  • Craniofacial trauma
  • Fixed nasopharyngeal abnormalities
  • Burns
  • Extreme obesity

Treatment and study plan

noninvasive mechanical ventilation

Device

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

Primary outcomes

  1. neural inspiratory time

    Time frame: 20-30 minutes

    Compare the neural inspiratory time during spontaneous breathing and noninvasive mechanical ventilation.

Secondary outcomes

  1. expiratory delay

    Time frame: 20-30 minutes

    to assess the expiratory delay during noninvasive mechanical ventilation

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Guangzhou Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 29, 2016
Registry last updated
Nov 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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