Electrical Impedance Tomography in Guiding Early and Precise Rehabilitation of Patients with Difficult Ventilator Weaning

NCT ID: NCT06677099

Last Updated: 2024-11-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-07
• Study Completion Date: 2025-12-30

Brief Summary

Diaphragm dysfunction, ineffective chest wall and respiratory muscle function are frequently observed in critically ill patients with difficult weaning from mechanical ventilation(MV).It is the leading cause of retention of airway secretions and insufficient airway clearance.Thechest physiotherapy (CPT) of critically ill patients can reduce secretion retention. We designed a protocol to investigate the feasibility and efficacy of CPT guided by electrical impedance tomography (EIT) in Difficult-to-Wean patients.

Conditions

Difficult-to-Wean Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Control group

Two sessions of CPT (morning and afternoon, 20 minutes each) were conducted. The CPT session consisted of modified postural drainage, assisted cough technique, positive expiratory pressure and chest percussion, vibration. The appointed therapist performed pulmonary auscultation and thoracic palpation to assess the status of pulmonary ventilation and secretion retention, and whether the patient's cough ability can complete effective airway clearance. Individualized program was formed according to the assessment, internal guidelines, the patient's tolerance, education level, and patient's preference prior to the randomization. All CPT sessions were performed by the same physiotherapist to avoid potential bias.

Group Type: EXPERIMENTAL

chest physiotherapy

Intervention Type: PROCEDURE

Two sessions of CPT (morning and afternoon, 20 minutes each) were conducted. The CPT session consisted of modified postural drainage, assisted cough technique , positive expiratory pressure and chest percussion, vibration. The appointed therapist performed pulmonary auscultation and thoracic palpation to assess the status of pulmonary ventilation and secretion retention, and whether the patient's cough ability can complete effective airway clearance. Individualized program was formed according to the assessment, internal guidelines, the patient's tolerance, education level, and patient's preference prior to the randomization. All CPT sessions were performed by the same physiotherapist to avoid potential bias.

EIT-guided group

EIT-guided group: Similar to the patients in the Control group, the CPT techniques were predefined for the patients according to the assessment prior to the randomization. For each CPT session, EIT measurement was conducted and the images were used to guide the CPT treatments. The uses of EIT to guide individual treatments are briefly described as follows.

Group Type: EXPERIMENTAL

EIT-guided chest physiotherapy

Intervention Type: PROCEDURE

EIT-guided modified postural drainage combined with vibrations and chest percussion: tidal variation images in EIT reveals heterogeneously ventilated regions. Physiotherapist identified such regions at the bedside and instructed the patient to take the appropriate drainage position, so that the poorly ventilated regions became gravity non-dependent regions. Subsequently, the physiotherapist put her hands on the poorly ventilated area with a vibratory force. A compressive pressure was produced by the therapist's arms.

Interventions

chest physiotherapy

Two sessions of CPT (morning and afternoon, 20 minutes each) were conducted. The CPT session consisted of modified postural drainage, assisted cough technique , positive expiratory pressure and chest percussion, vibration. The appointed therapist performed pulmonary auscultation and thoracic palpation to assess the status of pulmonary ventilation and secretion retention, and whether the patient's cough ability can complete effective airway clearance. Individualized program was formed according to the assessment, internal guidelines, the patient's tolerance, education level, and patient's preference prior to the randomization. All CPT sessions were performed by the same physiotherapist to avoid potential bias.

Intervention Type: PROCEDURE

EIT-guided chest physiotherapy

EIT-guided modified postural drainage combined with vibrations and chest percussion: tidal variation images in EIT reveals heterogeneously ventilated regions. Physiotherapist identified such regions at the bedside and instructed the patient to take the appropriate drainage position, so that the poorly ventilated regions became gravity non-dependent regions. Subsequently, the physiotherapist put her hands on the poorly ventilated area with a vibratory force. A compressive pressure was produced by the therapist's arms.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• mechanical ventilation patients who are ≥18 years old, are received to invasive mechanical ventilation more than 96 hours before randomization, are meted the preconditions for the machine to be withdrawn, and at least have one failed attempt to withdraw the ventilator (re-need ventilator support within 48 hours after extubation),
• willing to participate in the study and sign the informed consentsent.

Exclusion Criteria

• Malignant arrhythmia or acute myocardial ischemia
• Pneumothorax, pulmonary bulla and barotrauma and other lung diseases
• Hemorrhagic disease or abnormal coagulation mechanism with bleeding tendency
• Chest skin trauma
• Pulmonary hypertension and pulmonary embolism
• With a permanent or temporary pacemaker
• There is malignant tumor
• Present and previous history of neuromuscular diseases affecting respiratory muscle
• Participated in another clinical study related to mechanical ventilation withdrawal
• Can not cooperate with the study for any reason or the researcher thinks that it is not suitable to be included in this experiment.

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

Sponsors

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Jingyi Ge

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jingyi Ge

Role: PRINCIPAL_INVESTIGATOR

Beijing Rehabilitation Hospital of Capital Medical University

Central Contacts

Jingyi Ge

Role: CONTACT

ge_jingyi2020@163.com

References

Wang H, Xi J, Jiang H. Randomized clinical study of electrical impedance tomography-guided chest physiotherapy in difficult-to-wean patients: study protocol. PeerJ. 2025 Aug 4;13:e19727. doi: 10.7717/peerj.19727. eCollection 2025.

Reference Type: DERIVED

PMID: 40777077 (View on PubMed)

Other Identifiers

2022-030

Identifier Type: -

Identifier Source: org_study_id