Respiratory System Compliance Guided VT in Moderate to Severe ARDS Patients

NCT02814994 | Completed

• 1 other identifier: ARDS protocol treatment
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

Brief Summary

The Acute Respiratory Distress Syndrome (ARDS) is one of common clinical critically diseases. In the United States, the incidence of ARDS reaches 31%, which is one of the main causes of death in patients. There is no unified treatment process for ARDS currently and the treatment measures are not yet standardized, so the standardization of ARDS treatment processes is needed to reduce mortality in patients. Following the evidence-based medicine principles and six-step treatment standards of ARDS, this study uses the method of multi-center randomized controlled clinical trials to evaluate the standardized treatment process of ARDS, which provides the basis for the standardized treatment of ARDS.

Conditions

Respiratory Failure; Acute Respiratory Distress Syndrome

Keywords

Mechanical Ventilation; ARDS; Ventilator Strategy; Outcome

Outcome Measures

Primary Outcomes (1)

• the effects of tidal volume guided by respiratory system compliance on mortality in patients suffering from ARDS

  28-days

Study Arms (2)

tidal volume guided by respiratory system compliance

EXPERIMENTAL

effects of tidal volume guided by respiratory system compliance on mortality in patients suffering from ARDS

Behavioral: tidal volume guided by respiratory system compliance

low tidal volume

EXPERIMENTAL

Ventilated patients with low tidal volume

Behavioral: low tidal volume

Interventions

tidal volume guided by respiratory system compliance BEHAVIORAL

ventilated with tidal volume guided by respiratory system compliance

tidal volume guided by respiratory system compliance

low tidal volume BEHAVIORAL

ventilation ventilated with low tidal volume

low tidal volume

Eligibility Criteria

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

You may qualify if:

• aged ≥ 18 years
• admitted to the ICU
• according to the diagnostic criteria of ARDS Berlin definition，admit patients with severe ARDS

You may not qualify if:

• age \<18 years old
• be expected to die within 24 hours
• end-stage malignancies
• be participating in other studies, which may affect the results of this study
• DNI (do not intubation) and DNR (do not recovery) patients
• family members do not agree to sign an informed consent

Sponsors & Collaborators

• Southeast University, China: lead

Study Sites (1)

Zhongda Hospital

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Lung Diseases

Study Officials

• Haibo Qiu, Prof.

  southeast university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physician, Zhongda Hospital

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: June 28, 2016
• Study Start: September 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 28, 2016

Record last verified: 2016-06

Locations

CN (1)