Effectiveness of Recruitment Maneuvers and Lung Protective Ventilation Strategy in ARDS

ARDS Clinical Trial

— ARDS  

Official title:

Effectiveness of Recruitment Maneuvers and Lung Protective Ventilation Strategy in ARDS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05023226
• Other study ID #: AUH-CT-ZK01
• Status: Recruiting
• Phase: N/A
• Start date: October 5, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: January 2023
• Source: Asia University
• Contact: Zi-Tin Kuan, RN
• Phone: 886-966083885
• Email: kuan.zitin[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• ARDS

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	Asia University	Taichung	Wufeng

Sponsors (1)

Lead Sponsor	Collaborator
Asia University

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Chung FT, Lee CS, Lin SM, Kuo CH, Wang TY, Fang YF, Hsieh MH, Chen HC, Lin HC. Alveolar recruitment maneuver attenuates extravascular lung water in acute respiratory distress syndrome. Medicine (Baltimore). 2017 Jul;96(30):e7627. doi: 10.1097/MD.000000000 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygenation index(OI)	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?	Baseline - 72 hrs after enrollment
Primary	Lung ultrasound score(LUS)	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?	Baseline - 72 hrs after enrollment
Secondary	Ventilator days	Removal of endotracheal tube without ventilator support days	Removal of endotracheal tube day - Insertion endotracheal tube day + 1 day
Secondary	Length of stay in the ICU (days)	Total days of admission ICU	Transfer out of ICU day - Admission to ICU day + 1 day
Secondary	ICU mortality	In ICU death after admission to the ICU	During ICU course

External Links

•   doi: 10.1097/MD.0000000000007627