Effectiveness of Recruitment Maneuvers and Lung Protective Ventilation Strategy in ARDS (ARDS)

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), extravascular lung water index (EVLWI) 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 Overview

• Status: Not yet recruiting
• Conditions: ARDS
• Intervention / Treatment: Procedure: LPVS; Procedure: RM

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), extravascular lung water index (EVLWI) 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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zi-Tin Kuan, RN; Phone Number: 886-966083885; Email: kuan.zitin@gmail.com

Study Locations

• Taiwan
  • Wufeng
    • Taichung, Wufeng, Taiwan, 41354
      • Asia University
      • Contact: Jiun-Yi Wang, Ph.D.; Phone Number: 1861 886-42332-3456; Email: jjwang@asia.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: LPVS group; The general ventilator setting.	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.; Other Names: Lung protective ventilation strategies
Experimental: LPVS + RM group; Recruitment maneuver.	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.; Other Names: Lung protective ventilation strategies; 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.; Other Names: Recruitment maneuver

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Extravascular lung water index (EVLWI)	Difference in EVLWI between baseline and 72 hrs after enrollment 【EVLWI is the amount of water that is contained in the lungs outside the pulmonary vasculature. In the normal lung, the value of the normal EVLW is <7 mL/kg of body weight】	Baseline - 72 hrs after enrollment
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Asia University
• Investigators: Study Director: Zi-Tin Kuan, RN, Asia University Hospital

Publications and helpful links

General Publications

• 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.

Helpful Links

• doi: 10.1097/MD.0000000000007627

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: August 21, 2021
• First Submitted That Met QC Criteria: August 25, 2021
• First Posted (Actual): August 26, 2021

Study Record Updates

• Last Update Posted (Actual): September 2, 2021
• Last Update Submitted That Met QC Criteria: August 29, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Acute respiratory distress syndrome (ARDS); Recruitment maneuvers (RM); Oxygenation index(OI); Extravascular lung water index (EVLWI); Lung ultrasound score(LUS)
• Other Study ID Numbers: AUH-CT-ZK01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No