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

NCT ID: NCT06702813

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-19
• Study Completion Date: 2025-12-01

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.

Detailed Description

This is an interventional study evaluating the beneficial impact of CHFO (Continuous High Frequency Oscillatory Ventilation) in awake ICU patients with atelectasis on ventilatory function.

This therapeutic study aims to treat patients using the CHFO machine (MetaNeb system). The study involves comparing pulmonary pathophysiological parameters before and after CHFO treatment in awake patients with atelectasis.

The primary outcome is the difference in chest electrical impedance tomography (EIT) measurements taken at the end of CHFO treatment (10 minutes) compared to the baseline value measured at the beginning of the protocol.

The minimum number of subjects to enroll in this study is 45 patients. Intermediate analyses are planned after every 5 patients to reassess the required number of patients.

Baseline data collected at the beginning of the protocol include pulse oximetry and measurements of heart rate and blood pressure. During the treatment, pulse oximetry and measurements of heart rate and blood pressure will be collected. At the end of the treatment, arterial blood gas analysis, heart rate, and blood pressure will be measured. EIT data will be collected at 10 minutes before the start of CHFO, during treatment, and 10 minutes after the treatment. At the end of the treatment, collect patients' subjective ratings of treatment comfort.

Conditions

Atelectasis, Postoperative; Hypoxia; Critical Illness

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CHFO group

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.

Group Type: EXPERIMENTAL

High-Frequency Oscillatory Ventilation

Intervention Type: DEVICE

Administer 10 minutes of high-frequency oscillatory ventilation in awake ICU patients.

Interventions

High-Frequency Oscillatory Ventilation

Administer 10 minutes of high-frequency oscillatory ventilation in awake ICU patients.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shengyu Hao, PhD

Role: CONTACT

janet9yu@163.com

02164041990 ext. 13671

Yuxian Wang, B.S.

Role: CONTACT

Wang.yuxian@zs-hospital.sh.cn

02164041990

Facility Contacts

Ming Zhong, PhD

Role: primary

zhong.ming@zs-hospital.sh.cn

02164001990 ext. 114

Other Identifiers

ZSZZ202411

Identifier Type: -

Identifier Source: org_study_id