A Multicenter, Random Control Study :Early Use of Airway Pressure Release Ventilation (APRVplus) Protocol in ARDS

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

A Multicenter, Random Control Study: Early Use of Airway Pressure Release Ventilation Updated (APRVplus) Protocol in Acute Respiratory Disease Syndrome (ARDS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03549910
• Other study ID #: Huaxi ICU-APRV
• Status: Recruiting
• Phase: N/A
• Start date: December 10, 2020
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2024
• Source: West China Hospital
• Contact: Yongfang Zhou
• Phone: 86 18140212276
• Email: zyfmg[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Animal experimentals have shown that the more physiology-driven airway pressure release ventilation (APRV) methodologies in ARDS may significantly improve alveolar recruitment and gas exchange, increased homogeneity, and attenuate lung injury, without circulatory depression, as compared with conventional low tial volume lung protective ventilation. our previous single centre,random control study showed that clinical benefit for early use of APRV in ARDS. Nonetheless, clinical data on ARDS are still limited, most of them derived from small clinical trials in which variable outdated APRV settings were used, consequently, the findings of these studies were controversial.

Additionally, the previous single-centre,random control study showed that clinical benefit for APRV.Therefore,the investigators are ready to design a multiple centres,random control study to further verify the effect of APRV plus protocol in ARDS.

Description:

All the patients included will be randomly assigned to receiving APRV plus protocol or low tidal volume ventilation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 840
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Moderate and severe acute respiratory distress syndrome,according to the Berlin definition of ARDS

• receiving tracheal intubation and mechanical ventilation was no longer than 48 hours

Exclusion Criteria:

• Pregnancy

• The expected duration of mechanical ventilation was less than 48 hours

• Intracranial hypertension (suspected or confirmed)

• Neuromuscular disorders that are known to prolong the need for mechanical ventilation

• Known or suspected chronic obstructive pulmonary disease(COPD)

• Terminal stage of disease

• Pneumothorax (drained or not)at enrollment

• Treatment with extracorporeal support (ECMO) at enrollment

• There was a lack of commitment to life support.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• APRVplus protocol
Physiology-driven APRVplus protocol
• Low tidal volume ventilation
Low tidal volume lung protective ventilation

Locations

Country	Name	City	State
China	West China Hospital,Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	adverse events related to mechanical ventilation	including pneumothorax,VAP,and so on	during the mechanical ventilation procedure
Primary	mortality	mortality at Day28	Day 28
Secondary	Mechanical ventilation free days	Mechanical ventilation free days at Day28	Day 28
Secondary	oxygenation	oxygenation index:PaO2:fiO2	from enrollment to Day7
Secondary	repiratory system compliance	static repiratory system compliance (ml/cmH2O)	from enrollment to Day7
Secondary	MAP	mean arterial pressure	during the mechanical ventilation procedure
Secondary	sedation depth	RASS scores	during the mechanical ventilation procedure
Secondary	Sedative drug	the total dose of Sedative drug	during the mechanical ventilation procedure
Secondary	successful extubation rate	the rate of successful extubation	during the mechanical ventilation procedure