NCT05023226

Effectiveness of Recruitment Maneuvers and Lung Protective Ventilation Strategy in ARDS

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Asia University · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• ARDS

Interventions

Type	Name	Description
PROCEDURE	RM	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 level was fixed to 40 seconds in each increment. Then, the ventilator was transferred to PEEP-titration phase, the PEEP was adjusted to 25 cm H2O, and it was reduced by increments of 5 cm H2O each time. The each increment was fixed to 5 minutes till the end-maneuver PEEP.
PROCEDURE	LPVS	LPVS was used by the pressure-controlled mode and the PEEP was titrated by the level of FiO2 to keep the saturation of oxygen (SaO2) more than 90%. The level of pressure control was adjusted to maintain low tidal volume (6-8 mL/kg predicted body weight \[PBW\]) strategy. The respiratory rate and tidal volume were setting to avoid unstable hemodynamic data and adjusted by blood gas data and lung mechanics.

Timeline

• Start date: 2021-10-05
• Primary completion: 2023-08-31
• Completion: 2023-08-31
• First posted: 2021-08-26
• Last updated: 2023-02-01

Locations

1 site across 1 country: Taiwan