Clinical trial NCT05435079: Research on a NTHF to Improve Pulmonary Function in Patients With Respiratory Failure
Official title: Research on a New Nursing Model of New High-flow Oxygen Inhalation Device to Improve Pulmonary Function in Patients With Respiratory Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Insufficiency
Lead sponsor: Shenzhen Second People's Hospital
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Before the start of the study, all enrolled patients were required to sign an informed consent form. Patients who met the inclusion criteria were divided into NTHF (observation group) and AIRVOTM2 (Fisher \& Paykel, Auckland, New Zealand) group (control group) in a 1:1 ratio.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Patient who ≥18 years old and meets the diagnostic criteria for respiratory failure
2. Have an artificial airway, ready or have been released from the ventilator
3. The circulation is basically stable, and there are no shocks of various types that are difficult to correct (mean arterial pressure remains unchanged under the condition of vasoactive drugs).

   \<65mmHg)
4. Consciousness and ability to cooperate with clinical treatment

Exclusion Criteria:

1. Pregnancy and end-stage cancer patients
2. History of airway injury, pulmonary trauma, and lung surgery
3. Central respiratory failure or status asthmaticus caused by neurological diseases
4. Refusing to cooperate with treatment or to participate in the researcher

Primary outcomes:
measure: Level of oxygenation
timeFrame: 24hours after start of high flow oxygen therapy
measure: Level of oxygenation
timeFrame: 48 hours after start of high flow oxygen therapy
measure: Level of oxygenation
timeFrame: 7th days after start of high flow oxygen therapy
Secondary outcomes:
measure: level of sputum viscosity
timeFrame: 24th, 48th and 7th days after start of high flow oxygen therapy
measure: Patient satisfaction scoreg greater than or equal to 90
timeFrame: the 7th day after start of high flow oxygen therapy
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
state: Guangdong
Study officials:
affiliation: Shenzhen Second People's Hospital
name: MEI YANGMEI
role: STUDY_CHAIR
References: