Effectiveness of Recruitment Maneuvers and Lung Protective Ventilation Strategy in ARDS

NCT05023226 | Unknown

• 1 other identifier: AUH-CT-ZK01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

ARDS

Keywords

Acute respiratory distress syndrome (ARDS); Recruitment maneuvers (RM); Oxygenation index(OI); Lung ultrasound score(LUS)

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Ventilator days

  Removal of endotracheal tube day - Insertion endotracheal tube day + 1 day

• Length of stay in the ICU (days)

  Transfer out of ICU day - Admission to ICU day + 1 day

• ICU mortality

  During ICU course

Study Arms (2)

LPVS group

PLACEBO COMPARATOR

The general ventilator setting.

Procedure: LPVS

LPVS + RM group

EXPERIMENTAL

Recruitment maneuver.

Procedure: RM; Procedure: LPVS

Interventions

RM PROCEDURE

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.

Also known as: Recruitment maneuver

LPVS + RM group

LPVS PROCEDURE

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.

Also known as: Lung protective ventilation strategies

LPVS + RM group; LPVS group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asia University: lead

Study Sites (1)

Asia University

Taichung, Wufeng, 41354, Taiwan

RECRUITING

Related 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.0000000000007627.

  PMID: 28746224 RESULT

Related Links

• doi: 10.1097/MD.0000000000007627

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Zi-Tin Kuan, RN

  Asia University Hospital

  STUDY DIRECTOR

Central Study Contacts

Zi-Tin Kuan, RN

CONTACT

886-966083885; kuan.zitin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2021
• First Posted: August 26, 2021
• Study Start: October 5, 2021
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: February 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)