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

NCT05435079 | Unknown

• 1 other identifier: A2022088
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Insufficiency

Outcome Measures

Primary Outcomes (3)

• Level of oxygenation

  Oxygenation is assessed by arterial blood gas sample

  24hours after start of high flow oxygen therapy

• Level of oxygenation

  Oxygenation is assessed by arterial blood gas sample

  48 hours after start of high flow oxygen therapy

• Level of oxygenation

  Oxygenation is assessed by arterial blood gas sample

  7th days after start of high flow oxygen therapy

Secondary Outcomes (2)

• level of sputum viscosity

  24th, 48th and 7th days after start of high flow oxygen therapy

• Patient satisfaction scoreg greater than or equal to 90

  the 7th day after start of high flow oxygen therapy

Study Arms (2)

new type of tracheotomy high-flow oxygen therapy (NTHF)

EXPERIMENTAL

NTHF (connect the oxygen suction tube, Venturi, Fisher \& Paykel MR850 heated humidifier, RT308 breathing tube with humidification tank, airtight suction tube and tracheotomy in sequence from the output end of the automatic pressure-adjustable oxygen flow meter Catheter), adjust the MR850 to invasive automatic transmission, the temperature sensor automatically adjusts and maintains the gas temperature at the inlet of the tracheostomy catheter at 37°C according to the feedback temperature, and adjusts according to the gas outflow from the exhalation port of the patient's inspiratory phase. The gas flow rate of the oxygen therapy device is 40-60L/min. According to the monitored pulse oxygen saturation (SpO 2 ), the concentration of the venturi valve and the corresponding oxygen flow rate are adjusted to maintain the SpO 2 between 94% and 100%.

Device: high-flow oxygen therapy device for tracheotomized patients

Respiratory Humidification Treatment（ AIRVO TM 2）

ACTIVE COMPARATOR

AIRVOTM 2 (Fisher \& Paykel, Auckland, New Zealand), connect the special breathing circuit, tracheostomy joint and tracheostomy tube in sequence from the output end of the oxygen flow meter. The gas outflow from the mouth is the standard, adjust the output gas flow rate of the therapy device to 40-60L/min, adjust the oxygen concentration according to the monitored pulse oxygen saturation (SpO 2 ), and maintain the SpO 2 between 94% and 100%. .

Device: high-flow oxygen therapy device for tracheotomized patients

Interventions

high-flow oxygen therapy device for tracheotomized patients DEVICE

From the output end of the automatic pressure-adjustable oxygen flow meter, connect the oxygen suction tube, Venturi, Fisher \& Paykel MR850 heated humidifier, RT308 breathing tube with humidification tank, closed sputum suction tube and tracheostomy tube), Adjust the MR850 to invasive automatic transmission, the temperature sensor automatically adjusts and maintains the gas temperature at the inlet of the tracheostomy tube at 37°C according to the feedback temperature, and adjusts the oxygen therapy device according to the gas outflow from the exhalation port of the patient's inspiratory phase. The gas flow rate is 40-60L/min. According to the monitored pulse oxygen saturation (SpO 2 ), the concentration of the venturi valve and the corresponding oxygen flow rate are adjusted to maintain the SpO 2 between 94% and 100%.

Respiratory Humidification Treatment（ AIRVO TM 2）; new type of tracheotomy high-flow oxygen therapy (NTHF)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient who ≥18 years old and meets the diagnostic criteria for respiratory failure
• Have an artificial airway, ready or have been released from the ventilator
• 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)
• Consciousness and ability to cooperate with clinical treatment

You may not qualify if:

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

Sponsors & Collaborators

• Shenzhen Second People's Hospital: lead

Study Sites (1)

Shenzhen Second People's Hospital

Shenzhen, Guangdong, 518000, China

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• MEI YANGMEI

  Shenzhen Second People's Hospital

  STUDY CHAIR

Central Study Contacts

WENJING QIAN

CONTACT

0755-83464301; hyyoung95@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This study is a single-blind study. The researcher clearly defines the treatment group, but index evaluation, data collection and data statistics are completed by different trained researchers, and they don't know the specific grouping.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 14, 2022
• First Posted: June 28, 2022
• Study Start: July 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: June 30, 2024
• Last Updated: June 28, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)