Research of Spiral Exhalation Device Oxygen Therapy to Improve the Treatment Effect of Patients With Severe Pneumonia

NCT05452759 | Unknown

• 1 other identifier: 20223357002
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

Severe pneumonia has a high morbidity and mortality. Humidified oxygen therapy, mechanical ventilation, and removal of airway secretions are the main non-drug treatments. However, mechanical ventilation leads to a high economic burden, and ventilator-associated pneumonia may increase patient mortality. Therefore, it is necessary to conduct in-depth research on early release from the ventilator and oxygen therapy. Studies have shown that high-flow nasal oxygen therapy (HFNC) improves airway humidification and oxygenation in patients. The respiratory humidification therapy device (AIRVOTM2) is mainly used internationally, but clinical studies on artificial airway patients are limited. In the previous study, we improved the "New Artificial Airway High Flow Humidification Oxygen Therapy Device" (NTHF) to improve the accuracy of gas flow rate, and unified the baseline with AIRVOTM2. The status quo of the obvious differences in the airway humidification effect of patients. The pre-experiment again found that the gas flow rate consumption was significantly lower than that of AIRVOTM2 after the NTHF exhalation port was optimized, and the gas flow rate was proportional to the inhaled gas humidity. Based on this, we hypothesized that the flow rate of the optimized expiratory port of NTHF is more stable than that of AIRVOTM2, which can improve the airway humidification effect of patients. We intend to adopt a randomized controlled clinical study design, by comparing the application of two oxygen therapy devices in patients with severe pneumonia artificial airway, to explore whether NTHF can promote the clearance of airway secretions in patients with severe pneumonia and improve the therapeutic effect of severe pneumonia. Oxygen therapy nursing mode in patients with severe pneumonia artificial airway.

Conditions

Pneumonia

Outcome Measures

Primary Outcomes (3)

• level of flow rate proximal to the patient

  The gas flow rate was measured using the MF5612 split display gas mass flowmeter produced by Sixiang Microelectronics in the United States

  On the day of using the high-flow humidified oxygen therapy device

• level of flow rate proximal to the patient

  The gas flow rate was measured using the MF5612 split display gas mass flowmeter produced by Sixiang Microelectronics in the United States

  48 hours after start of high flow oxygen therapy

• level of flow rate proximal to the patient

  The gas flow rate was measured using the MF5612 split display gas mass flowmeter produced by Sixiang Microelectronics in the United States

  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

• Level of oxygenation

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

Other Outcomes (1)

• 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

Using NTHF, adjust the MR850 humidifier to invasive automatic gear, the temperature sensor automatically adjusts and maintains the gas temperature at the entrance of the tracheal tube at 37°C according to the feedback temperature, and monitors and maintains SpO2 between 94% and 100%. The monitored pulse oxygen saturation (SpO2) is used to adjust the concentration of the venturi valve and the corresponding oxygen flow rate. At the preset gas flow rate levels of 40L/min, 50L/min and 60L/min, the test pipeline is connected to optimize the breath. The actual gas flow rate value and the gas flow rate loss difference before and after the gas joint (screw joint), and at the corresponding gas flow rate, measure the gas temperature and humidity at the near-patient end of the pipeline.

Device: high-flow oxygen therapy device for Severe pneumonia patients with artificial airway

Respiratory Humidification Treatment（ AIRVO TM 2）

ACTIVE COMPARATOR

Use AIRVOTM2 (Fisher \& Paykel, Auckland, New Zealand), select the output gas temperature of 37°C, monitor and maintain SpO2 between 94% and 100%, and adjust the output gas flow rate of the therapy device to 40L/min, 50L/min and 60L/min, respectively. min, measure the actual gas flow rate value and the gas flow rate loss difference before and after each flow rate horizontal pipeline is connected to the conventional exhalation joint (matching special exhalation joint), and measure the gas temperature and humidity near the patient end of the pipeline at the corresponding gas flow rate.

Device: AIRVOTM2 device for Severe pneumonia patients with artificial airway

Interventions

high-flow oxygen therapy device for Severe pneumonia patients with artificial airway DEVICE

Using NTHF, adjust the MR850 humidifier to invasive automatic gear, the temperature sensor automatically adjusts and maintains the gas temperature at the entrance of the tracheal tube at 37°C according to the feedback temperature, and monitors and maintains SpO2 between 94% and 100%. The monitored pulse oxygen saturation (SpO2) is used to adjust the concentration of the venturi valve and the corresponding oxygen flow rate. At the preset gas flow rate levels of 40L/min, 50L/min and 60L/min, the test pipeline is connected to optimize the breath. The actual gas flow rate value and the gas flow rate loss difference before and after the gas joint (screw joint), and at the corresponding gas flow rate, measure the gas temperature and humidity at the near-patient end of the pipeline.

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

AIRVOTM2 device for Severe pneumonia patients with artificial airway DEVICE

Use AIRVOTM2 (Fisher \& Paykel, Auckland, New Zealand), select the output gas temperature of 37°C, monitor and maintain SpO2 between 94% and 100%, and adjust the output gas flow rate of the therapy device to 40L/min, 50L/min and 60L/min, respectively. min, measure the actual gas flow rate value and the gas flow rate loss difference before and after each flow rate horizontal pipeline is connected to the conventional exhalation joint (matching special exhalation joint), and measure the gas temperature and humidity near the patient end of the pipeline at the corresponding gas flow rate.

Respiratory Humidification Treatment（ AIRVO TM 2）

Eligibility Criteria

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

You may qualify if:

• The age of the patient is ≥18 years old and meets the diagnostic criteria for severe pneumonia.
• The patient has artificial airway preparation or has been released from the ventilator.
• Needs to receive oxygen therapy for more than 24 hours.
• The expected retention days of the tracheal tube ≥ 7 days ⑤ Sign the informed consent

You may not qualify if:

• Patients with one-lung ventilation
• Patients with pregnancy and end-stage tumors ③Airway hemorrhage
• Medical history of airway injury, pulmonary trauma, lung surgery ⑤ Hypothermia (\<35℃), restrictive body fluid deficiency

Sponsors & Collaborators

• Shenzhen Second People's Hospital: lead

Study Sites (1)

Shenzhen Second People's Hospital

Shenzhen, Guangdong, 518000, China

Location

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; 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
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 11, 2022
• Study Start: August 1, 2022
• Primary Completion: August 30, 2024
• Study Completion: June 30, 2025
• Last Updated: July 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)