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

NCT06702813 | Recruiting DMC

• 1 other identifier: ZSZZ202411
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Atelectasis, hypoxemia, and ineffective sputum clearance are common problems in ICU patients. 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), thereby improving lung function by achieving and maintaining lung recruitment. However, the physiological effects and safety of CHFO in awake critically ill patients are still lacking relevant research. The objective of this study is to evaluate the comfort, safety, and efficacy of CHFO in awake critically ill patients.

Conditions

Atelectasis, Postoperative; Hypoxia; Critical Illness

Keywords

HFOV; EIT; atelectasis

Outcome Measures

Primary Outcomes (1)

• EIT

  In EIT monitoring, a 16-electrode belt was placed around the chest to record signals. Measurements will be taken at three time points: (1) within 10 minutes before the start of CHFO, (2) during the treatment, and (3) within 10 minutes after its completion.

  Baseline, during the treatment, and at the end of the intervention (10th minute).

Secondary Outcomes (3)

• SpO2 before, during and after the CHOF treatment

  Baseline, during the treatment, and at the end of the intervention (10th minute).

• Mean arterial pressure

  Baseline, during the treatment, and at the end of the intervention (10th minute).

• Comfort Rating

  Within 10 minutes after the treatment

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 10 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 awake ICU patients.

CHFO group

Eligibility Criteria

• Age: 18 Months - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 18 and younger than 90 years;
• Admitted to the ICU after December 1, 2024, who are alert, with a GCS of 15, normal comprehension, and able to communicate clearly through speech or writing.
• Patients with atelectasis, who are receiving oxygen therapy, high-flow oxygen, or are on a ventilator via tracheostomy.
• Signed informed consent for MetaNeb treatment.

You may not qualify if:

• Refusal to participate in the proposed study.
• Age \< 10 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. With a clear tracheoesophageal fistula

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Atelectasis; Hypoxia; Critical Illness

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Central Study Contacts

Shengyu Hao, PhD

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
• 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 ICU patients.

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: November 25, 2024
• Study Start: November 19, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 25, 2024

Record last verified: 2024-11

Locations

CN (1)