Research on a NTHF to Improve Pulmonary Function in Patients With Respiratory Failure

Respiratory Insufficiency Clinical Trial

Official title: Research on a New Nursing Model of New High-flow Oxygen Inhalation Device to Improve Pulmonary Function in Patients With Respiratory Failure

Status Not yet recruiting

Clinical Trial Summary

Patients with respiratory failure have high morbidity and mortality. Long-term mechanical ventilation causes a high medical burden and cannot cure respiratory failure. Therefore, in-depth research on early weaning and oxygen therapy nursing mode is needed. Currently, studies on artificial airway high-flow oxygen therapy are limited. Studies have reported that oxygen inhalation devices that increase expiratory resistance produce flow-dependent positive airway pressure and lung volume effects that improve oxygenation and ventilation. It means that the innovation of oxygen therapy device may be a change The key to improving lung function and reducing mechanical ventilation in patients with respiratory failure.

The project team is committed to the innovation of high-flow oxygen therapy devices and the research on oxygen therapy care. In the early stage, the "New Artificial Airway High Flow Oxygen Therapy Device" was designed (NTHF), in 2018, the new technology and new projects were declared and approved to solve the problem of the flow rate of oxygen therapy devices. In the pre-test, 78 tracheotomy patients were observed using NTHF and respiratory humidification therapy device (AIRVOTM2 ) with high-flow oxygen therapy. As a result, NTHF was superior to AIRVOTM2 in improving airway humidification, oxygenation effect and cost, and published an article, which was approved in 2019 "Non-inferiority of humidification performance of a novel high-flow oxygen therapy device in oxygen therapy for tracheostomy-off-weaned patients. In 2021, it will be approved for the promotion of appropriate technologies for health and health in Guangdong Province. Relying on the high-level clinical key specialties of Guangdong Province, support with scientific research technology and financial support conditions.

Research hypothesis: NTHF has the physiological effects of increasing the positive expiratory pressure of artificial airway, alveolar ventilation, and humidification, and can improve the lung function of patients with respiratory failure after tracheotomy.

Clinical Trial Description

1.1 Patients with respiratory failure have high morbidity and mortality. Long-term mechanical ventilation causes a high medical burden and cannot cure respiratory failure. Therefore, it is necessary to In-depth study of daily off-line and oxygen therapy nursing mode. Currently, studies on artificial airway high-flow oxygen therapy are limited. Studies have reported that increased expiratory resistance Oxygen inhalation devices produce flow-dependent positive airway pressure and lung volume effects that improve oxygenation and ventilation. It means that the innovation of oxygen therapy device may be a change.The key to improving lung function and reducing mechanical ventilation in patients with respiratory failure.

1.2 The project team is committed to the innovation of high-flow oxygen therapy devices and research on oxygen therapy care. In the early stage, the "New Artificial Airway High Flow Oxygen Therapy Device" was designed (NTHF), in 2018, the new technology and new projects were declared and approved to solve the flow rate problem of oxygen therapy devices ,observing 78 tracheotomized patients using NTHF and respiratory humidification therapy device (AIRVOTM2) Perform high-flow oxygen therapy. As a result, NTHF was superior to AIRVOTM2 in improving airway humidification, oxygenation, and cost, and published an article. Approved in 2019 "New high-flow oxygen therapy device in tracheotomy Non-inferiority study of humidification performance in oxygen therapy for weaned patients" (funded 150,000 yuan, China Clinical Research Registry, ChiCTR1900023421). 2021 , it was approved to promote the "Artificial Airway High Flow Oxygen Therapy Airtight Suction Technology" in Guangdong Province for Health and Health Appropriate Technology . Relying on Guangdong Province High-level clinical key specialties,support with scientific research technology and financial support condition.

1.3 Scientific assumption: NTHF has the physiological effects of increasing positive expiratory pressure of artificial airway, alveolar ventilation, and humidification, and can improve respiratory failure trachea,The patient's lung function was incised.

2 goals 2.1 To evaluate the effect of NTHF on improving pulmonary ventilation, ventilation and defense function in patients with respiratory failure artificial airway.

2.2 Obtain evidence that NTHF improves pulmonary function in patients with respiratory failure, and establish a new model of oxygen therapy nursing for patients with artificial airway in respiratory failure.

3 Research content 3.1 In a randomized parallel control method, NTHF and AIRVOTM2 were used in two groups of patients with respiratory failure artificial airway, and the two groups of patients were observed for 7 days.

The oxygenation index, respiratory rate, and mechanical ventilation time were analyzed, and the improvement of oxygenation in patients with respiratory failure by two oxygen therapy devices was analyzed.

3.2 Comparing the results of pulmonary function tests and microbial metagenomic testing of the two groups of patients before treatment and after 7 days of treatment, to explore the effect of NTHF on improving pulmonary function and patient comfort in patients with mild and moderate respiratory failure, and to explore the effect of NTHF in patients with respiratory failure caused by different diseases. A new model of oxygen therapy care.

4 Key issues to be addressed 4.1 To verify the effect of the new high-flow oxygen therapy device in improving oxygenation, ventilation and humidification of patients with respiratory failure artificial airway.

4.2 To explore whether the new high-flow oxygen therapy device can improve the lung function of patients with respiratory failure artificial airway, and establish a new model of oxygen therapy nursing.

5 Expected results 5.1 Academic indicators: Establish a personalized weaning scheme for patients with respiratory failure and a new nursing model for tracheotomy and high-flow humidified oxygen therapy. Published papers 1-2Participate in academic exchange conferences.

5.2 Talent training: train 1-2 respiratory therapists and graduate students. 5.3 Social and economic benefits: reduce the time of mechanical ventilation in patients with respiratory failure,Shorten the days of hospitalization, reduce costs, and reduce the burden on families and society. ;

Related Conditions & MeSH terms

• Respiratory Insufficiency

• NCT number: NCT05435079
• Study type: Interventional
• Source: Shenzhen Second People's Hospital
• Contact: WENJING QIAN
• Phone: 0755-83464301
• Email: hyyoung95@163.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2022
• Completion date: June 30, 2024