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

NCT06662630 | Recruiting DMC

• 1 other identifier: ZSZZ202410
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atelectasis; Acute Respiratory Distress Syndrome; VAP - Ventilator Associated Pneumonia

Keywords

mechanical ventilation; HFOV; EIT; FRC

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (5)

• Central venous pressure before and after the CHOF treatment

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

• PaO2/FiO2 ratio before and after the CHOF treatment

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

• Plateau pressure

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

• Mean arterial pressure

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

• Adverse events

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

Study Arms (1)

CHFO group

EXPERIMENTAL

After checking the availability of the CHFO machine (MetaNeb® system), the inclusion and non-inclusion criteria, the patient is included. The following procedures are performed: 1. installation of an EIT belt in the 4th or 5th intercostal space (Pulmovista® 500, Dräger) 2. continuous recording of digital and analogic data After collecting initial data from the patient within 30 minutes before CHFO treatment, successive 10-minutes CHFO were performed. At the end of the treatment, all the data is collected.

Device: High-Frequency Oscillatory Ventilation

Interventions

High-Frequency Oscillatory Ventilation DEVICE

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

CHFO group

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Participation in another trial within 30 days prior to meeting eligibility criteria;
• Severe chronic respiratory disease requiring long-term oxygen therapy or home mechanical ventilation;
• Pneumothorax;
• Expected duration of mechanical ventilation \< 48 hours
• Decision to refuse life-sustaining treatment.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Atelectasis; Respiratory Distress Syndrome; Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jian Zhou, PhD

  Fudan University

  STUDY DIRECTOR

Central Study Contacts

Shengyu Hao, Ph.D

CONTACT

02164041990; janet9yu@163.com

Yuxian Wang, B.S

CONTACT

02164041990; Wang.yuxian@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Analysis of data will be conducted by a statistician not involved in interventions at bedside
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional study evaluating the beneficial impact of continuous high-frequency oscillatory ventilation in patients with mechanical ventilation

Study Record Dates

• First Submitted: October 19, 2024
• First Posted: October 29, 2024
• Study Start: November 19, 2024
• Primary Completion: October 14, 2025
• Study Completion (Estimated): October 14, 2026
• Last Updated: November 20, 2024

Record last verified: 2024-10

Locations

CN (1)