Physiological Effects and Safety of Continuous High-frequency Oscillatory Ventilation in Mechanical Ventilation Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-90
SponsorShanghai Zhongshan Hospital

About this trial

Mechanical ventilation is an important treatment modality for intensive care unit (ICU) patients, but it also brings a series of problems such as ventilator-associated pneumonia, ventilator-induced lung injury, and atelectasis. Continuous High-Frequency Oscillation (CHFO )is often considered to have a protective effect on the lungs. CHFO provides effective gas exchange at supraphysiological frequencies while minimizing pressure fluctuations, producing tidal volumes smaller than dead space and adjusting around a continuously expanding pressure to optimize end-expiratory lung volume (EELV) by achieving and maintaining lung recruitment. However, the physiological effects and safety of CHFO in critically ill patients on mechanical ventilation lack relevant research. The objective of this research is to assess the feasibility, safety, and efficacy of CHFO in a population of mechanically ventilated critically ill patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients older than 18 and younger than 90 years;

Admitted to the ICU after October 15, 2024, who are intubated and expected to be unable to be extubated within 48 hours due to ARDS, or have atelectasis, or have VAP.

Signed informed consent for MetaNeb treatment.

Disqualifiers

Refusal to participate in the proposed study.

Age < 20 years;

Pregnancy;

Significant hemodynamic instability defined as an increase of more than 20% in catecholamine doses in the last hour, despite optimization of blood volume, for a target mean blood pressure between 65 and 75 mmHg.

Trial design

Design model

Single group

Treatments tested in this trial

  • High-Frequency Oscillatory Ventilation

    Device

    Administer 10 minutes of high-frequency oscillatory ventilation in mechanically ventilated patients.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: CHFO groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

EELV

EELV was measured utilizing the nitrogen washout-washin technique (E-sCOVX module sensor, GE Healthcare, Madison, WI, USA). The infusion of intravenous anesthetic agents and rocuronium bromide was administered to establish controlled mechanical ventilation during EELV measurement. Consistency in ventilator parameters was maintained throughout the EELV monitoring including follow-up measurements. Measurements will be taken at two time points: (1) Within 30 minutes before the start of CHFO and (2) within 30 minutes after its completion.

Time frame
Baseline, and at the end of intervention (30th minute)
2

EIT

In EIT monitoring, a 16-electrode belt was placed around the chest to record signals. Measurements will be taken at two time points: (1) Within 30 minutes before the start of CHFO and (2) within 30 minutes after its completion.

Time frame
Baseline, and at the end of intervention (30th minute)

Secondary outcomes

1

Central venous pressure before and after the CHOF treatment

The CVC is inserted via the internal jugular vein, subclavian vein, or femoral vein, depending on the patient and their condition. CVP is measured using a pressure measurement system, according to the measurement requirements. Measurements will be taken at two time points: (1) Within 30 minutes before the start of CHFO and (2) within 30 minutes after its completion.

Time frame
Baseline, and at the end of the intervention (30 minutes post-intervention)
2

PaO2/FiO2 ratio before and after the CHOF treatment

The PaO2/FiO2 ratio will be calculated by dividing the partial pressure of arterial oxygen (PaO2) by the fraction of inspired oxygen (FiO2). Measurements will be taken at two time points: (1) Within 30 minutes before the start of CHFO and (2) within 30 minutes after its completion.

Time frame
Baseline, and at the end of the intervention (30 minutes post-intervention)
3

Plateau pressure

Measured during an end-inspiratory pause of 3 seconds.

Time frame
Baseline, and at the end of the intervention (30 minutes post-intervention)
4

Mean arterial pressure

Mean arterial pressure measured continuously from the radial artery within 30 minutes before and after the treatment of CHOF and during the CHOF treatments.

Time frame
Baseline, during intervention, and at the end of intervention (30th minute)

Other outcomes

Sponsors and contacts

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