Effectiveness of Recruitment Maneuvers and Lung Protective Ventilation Strategy in ARDS

Asia University

Status: Enrolling

Conditions: ARDS

Treatments: Procedure: RM; Procedure: LPVS

Study type: Interventional

Funder types: Other

Identifiers

NCT05023226

AUH-CT-ZK01

Details and patient eligibility

About

The study was designed to comparison the effectiveness of recruitment maneuvers(RM) and lung protective ventilation strategy(LPVS) for patients with moderate to severe ARDS.

ARDS patients were randomly divided into two groups, the experimental group (LPVS+RM group) and the control group (LPVS group). The method of RM refers to that under FiO2=100% oxygen concentration and fixed inspiratory pressure (15cmH2O), the PEEP starts from 10 cmH2O and increases at a pressure of 5 cmH2O every minute until the Peak inspiratory Pressure(PIP) reaches 55cmH2O, and the arterial blood oxygen is monitored at the same time. The pressure point when the partial pressure of arterial oxygen PaO2+PaCO2≧400mmHg is the best PEEP. The primary endpoint indicators were oxygenation index(OI) and lung ultrasound score(LUS) from day 1 to day 7. The secondary outcome indicators were the ventilator days, length of stay in the ICU (days), and ICU mortality.

Full description

ARDS patients were randomly divided into two groups, the experimental group (LPVS+RM group) and the control group (LPVS group). The method of RM refers to that under FiO2=100% oxygen concentration and fixed inspiratory pressure (15cmH2O), the PEEP starts from 10 cmH2O and increases at a pressure of 5 cmH2O every minute until the Peak inspiratory Pressure(PIP) reaches 55cmH2O, and the arterial blood oxygen is monitored at the same time. The pressure point when the partial pressure of arterial oxygen PaO2+PaCO2≧400mmHg is the best PEEP. The primary endpoint indicators were oxygenation index(OI) and lung ultrasound score(LUS) from day 1 to day 7. The secondary outcome indicators were the ventilator days, length of stay in the ICU (days), and ICU mortality.

Enrollment: 30 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 20 to 70 years old.
• Patients with hypoxemia receiving endotracheal mechanical ventilation therapy.
• The ARDS diagnostic criteria of Berlin Definition, arterial oxygen tension [PaO2]/fractional inspired oxygen [FiO2] ratio (PaO2/FiO2) <200 mm Hg, recent appearance of bilateral pulmonary infiltrates consistent with edema and no clinical evidence of left atrial hypertension.
• Within 72 hours after ARDS diagnosis.

Exclusion criteria

• Pregnancy.
• Participate in other interventional trials at the same time during the acceptance period.
• Severe trauma combined with rib fracture or pneumothorax, subcutaneous emphysema, and mediastinal air accumulation within three months.
• Severe chronic respiratory diseases that require long-term use of oxygen therapy or home mechanical ventilation.
• Have a history of cachexia or terminal cancer.
• Use immunosuppressants, chemotherapy or radiation therapy.
• Contraindications for hypercapnia, such as patients with acute brain injury due to intracranial hypertension or craniotomy.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

LPVS group

Placebo Comparator group

Description:

The general ventilator setting.

Treatment:

Procedure: LPVS

LPVS + RM group

Experimental group

Description:

Recruitment maneuver.

Treatment:

Procedure: LPVS

Procedure: RM