Effectiveness of Recruitment Maneuvers and Lung Protective Ventilation Strategy in ARDS

Not Applicable

Recruiting

• Conditions: ARDS
• Interventions: Procedure: RM; Procedure: LPVS

• Registration Number: NCT05023226
• Lead Sponsor: Asia University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-08-21
• Study First Submitted QC: 2021-08-25
• Study First Posted: 2021-08-26
• Study Start: 2021-10-05
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-30
• Last Update Posted: 2023-02-01
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LPVS + RM group	RM	Recruitment maneuver.
LPVS + RM group	LPVS	Recruitment maneuver.
LPVS group	LPVS	The general ventilator setting.

Primary Outcome Measures

Name	Time	Method
Oxygenation index(OI)	Baseline - 72 hrs after enrollment	Difference in OI between baseline and 72 hrs after enrollment 【The oxygenation index assesses the intensity of ventilatory support that is needed to maintain adequate oxygenation. The formula is: Oxygenation index = (FiO2 x PAW) / PaO2. The lower the OI(\<25) the better the outcome】
Lung ultrasound score(LUS)	Baseline - 72 hrs after enrollment	Difference in LUS between baseline and 72 hrs after enrollment 【LUS is a score that measures lung aeration, score ranging from 0 to 36 points, the higher the score is mean the worse the ventilation of the lungs】

Secondary Outcome Measures

Name	Time	Method
Ventilator days	Removal of endotracheal tube day - Insertion endotracheal tube day + 1 day	Removal of endotracheal tube without ventilator support days
ICU mortality	During ICU course	In ICU death after admission to the ICU
Length of stay in the ICU (days)	Transfer out of ICU day - Admission to ICU day + 1 day	Total days of admission ICU

Trial Locations

Locations (1)

Asia University; 🇨🇳 Taichung, Wufeng, Taiwan