Effect of APRV and LTV on Lung Ventilation and Perfusion in Patients With Moderate-to-severe ARDS

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

Effect of APRV and LTV on Lung Ventilation and Perfusion in Patients With Moderate-to-severe ARDS: a Single-center, Pilot Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05767125
• Other study ID #: WUHICU202302
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: Wuhan Union Hospital, China
• Contact: Xiaojing Zou, prof.
• Phone: +862785351606
• Email: 249126734[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Low tidal volume ventilation (LTV) has been proposed and widely used in patients with acute respiratory distress syndrome (ARDS) to prevent ventilator-induced lung injury (VILI) and mitigate its effects. The LTV strategy is intended to protect the "baby lung" from overdistension while simultaneously allowing acutely injured tissue to continually collapse. Airway pressure release ventilation (APRV) is a highly effective strategy improving lung recruitment and oxygenation in clinical studies, but its effects on lung injury and mortality is debatable. Animal studies revealed that APRV could normalize post-injury heterogeneity and reduce the risk of VILI. Our objective was to investigate the impact of APRV and LTV on regional ventilation and perfusion distribution in ARDS patients by electrical impedance tomography (EIT).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patients aged =18 and =80 years;

2. Moderate-to-severe ARDS patients according to the Berlin definition;

3. Endotracheal mechanical ventilation =48 h before enrollment;

4. Expected to require continuous invasive mechanical ventilation =72 h.

Exclusion Criteria:

1. Severe chronic obstructive pulmonary disease, severe asthma, pulmonary bulla, subcutaneous emphysema, mediastinal emphysema, etc;

2. Contraindications to the use of electrical impedance tomography (e.g., chest surgical wounds dressing or presence of pacemaker);

3. Pulmonary interstitial lesions;

4. End-stage of chronic disease, with an expected survival period of <6 months;

5. Body mass index >35 kg/m2;

6. Refractory shock;

7. Intracranial hypertension;

8. Pregnant and parturient woman;

9. Intra-abdominal pressure persisted > 20 mmHg and could not be relieved within 24 hours;

10. Severe thoracic deformity;

11. Severe cardiac dysfunction;

12. Atrial fibrillation and other malignant arrhythmias that seriously affect cardiac output;

13. Pulmonary embolism;

14. Extracorporeal membrane oxygenation is needed;

15. Prone positioning was performed before randomization;

16. Patients who have participated in other clinical trials within 30 days;

17. Patients who have not signed informed consent.

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• APRV
Patients with moderate-to-severe ARDS were supported with APRV.
• LTV
Patients with moderate-to-severe ARDS were supported with LTV.

Locations

Country	Name	City	State
China	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung ventilation/perfusion matching	Lung ventilation/perfusion matching assessed by EIT	24hour
Secondary	Lung ventilation distrubution	Lung ventilation distrubution assessed by EIT	up to 72hour
Secondary	Lung perfusion distrubution	Lung perfusion distrubution assessed by EIT	up to 72hour
Secondary	Dead-space% and shunting%	Lung Dead-space% and shunting% assessed by EIT	up to 72hour
Secondary	Oxygenation index	Oxygenation index=Arterial partial pressure of oxygen /fraction of inspired oxygen	up to 72hour
Secondary	Arterial partial pressure of carbon dioxide (PaCO2)	PaCO2 is one of the key indicators of pulmonary ventilation which can be obtained from arterial blood gas analysis.	up to 72hour
Secondary	Static respiratory compliance (Crs)	Crs=tidal volume/driving pressure	up to 72hour
Secondary	Cardiac output	Cardiac output assessed by echocardiography	up to 72hour
Secondary	Right ventricular function	Right ventricular function assessed by echocardiography	up to 72hour
Secondary	Ventilator free days	28d-ventilator free days after randomization	up to 28days
Secondary	Duration of Intensive care units stay	28d-duration of Intensive care units stay after randomization	up to 28days
Secondary	Mortality after randomization	28d-all-cause mortality	up to 28days