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NCT05435079
Research on a NTHF to Improve Pulmonary Function in Patients With Respiratory Failure
NA trial testing high-flow oxygen therapy device for tracheotomized patients in Respiratory Insufficiency in 138 participants. Status unknown.
1 August 2022
Quick facts
| Lead sponsor | Shenzhen Second People's Hospital |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | supportive care |
| Enrollment | 138 |
| Start date | 1 July 2022 |
| Primary completion | 1 August 2022 |
| Estimated completion | 30 June 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- high-flow oxygen therapy device for tracheotomized patients
Conditions studied
- Respiratory Insufficiency — all drugs for Respiratory Insufficiency →
Sponsor
Shenzhen Second People's Hospital
Who can join
18 and older, any sex, with Respiratory Insufficiency. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05435079
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05435079 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shenzhen Second People's Hospital
- Last refreshed: 28 June 2022
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