Clinical trial NCT05023226: Effectiveness of Recruitment Maneuvers and Lung Protective Ventilation Strategy in ARDS
Official title: Effectiveness of Recruitment Maneuvers and Lung Protective Ventilation Strategy in ARDS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ARDS
Keywords: Acute respiratory distress syndrome (ARDS)
Recruitment maneuvers (RM)
Oxygenation index(OI)
Lung ultrasound score(LUS)
Lead sponsor: Asia University
Sponsor class: OTHER
First posted: 2021-08-26
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Oxygenation index(OI)
timeFrame: Baseline - 72 hrs after enrollment
measure: Lung ultrasound score(LUS)
timeFrame: Baseline - 72 hrs after enrollment
Secondary outcomes:
measure: Ventilator days
timeFrame: Removal of endotracheal tube day - Insertion endotracheal tube day + 1 day
measure: Length of stay in the ICU (days)
timeFrame: Transfer out of ICU day - Admission to ICU day + 1 day
measure: ICU mortality
timeFrame: During ICU course
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Asia University
state: Wufeng
Study officials:
affiliation: Asia University Hospital
name: Zi-Tin Kuan, RN
role: STUDY_DIRECTOR
References:
citation: 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.0000000000007627.