Clinical trial NCT02387437: Different Effects of Three Recruitment Maneuvers on the Lung Heterogeneity of Acute Respiratory Distress Syndrome
Official title: Evaluation of Different Effects of Three Recruitment Maneuvers on the Lung Heterogeneity of Acute Respiratory Distress Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Keywords: ARDS
EIT
recruitment maneuvers
Lead sponsor: Southeast University, China
Sponsor class: OTHER
Collaborators: name: Zhongda Hospital
First posted: 2015-03-13
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Acute respiratory distress syndrome (ARDS) is the common disease in clinical, which pathophysiology is a lot of alveolar collapse and heterogeneity. Recruitment maneuver is one of the important therapy for improvement of this phenomenon. The previous research focuses on the hemodynamic and oxygenation effect of recruitment maneuver on the lung of ARDS. Seldom investigators try to find the intuitive change of heterogeneity when recruitment maneuver is implemented. In this study, the investigators compare three recruitment maneuvers on the lung heterogeneity of ARDS.

Detailed description: Acute respiratory distress syndrome (ARDS) is the common disease in clinical,which pathophysiology is a lot of alveolar collapse and heterogeneity. Recruitment maneuver is one of the important therapy for improvement of this phenomenon. The previous research focuses on the hemodynamic and oxygenation effect of recruitment maneuver on the lung of ARDS. Seldom investigators try to find the intuitive change of heterogeneity when recruitment maneuver is implemented. In this study, the investigators compare three recruitment maneuvers on the lung heterogeneity of ARDS.

Electrical impedance tomography (EIT) has been introduced as a true bedside and radiation-free technique which provides information on heterogeneity. The investigators compare effects of three recruitment maneuvers on lung heterogeneity before recruitment maneuver and do the same thing after three recruitment maneuvers.

Ninety-three patients with ARDS will be enrolled . These patients are treated routinly.They need to recept a time of ZEEP (PEEP is zero cmH2O)for ten respiratory cycles before RM(recruitment maneuvers).Implemente a kind of RM at random immediately after ZEEP,Then make the ventilator same as before ZEEP.The EIT images ,blood gases and hemodynamic variables will be examined as beseline between ZEEP and RM.Completion of this kind of RM lies that the P/F of blood gases 3 minutes after RM achieves (1) PO2/FiO2\>400mmHg or (2)PO2/FiO2+PCO2 ≥ 400mmHg(FiO2=1)，(3)the difference between this index before lung recriument and after lung recriument PO2/FiO2\<5%.In addition,3 minutes after RM,compare the indexs above between three methods.

Eligibility criteria: Inclusion Criteria:

* Patients who are severe or moderate ARDS
* Patients who have signed ICF

Exclusion Criteria:

* Patients who are younger than 18 years old or older than 75 years old
* Patients whose vital signs are unstable
* Patients who are in other clinical trails
* Patients who are pregnant

Primary outcomes:
measure: oxygenation (improvement of oxygenation)
timeFrame: improvement of oxygenation 3 minutes after lung recruiment
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda hospital, Southeast University
state: Jiangsu
city: Nanjing
country: China
facility: Zhongda hospital, Southeast University
state: Jiangsu
Study officials:
affiliation: southeast univerity, China
name: Yingzi Huang
role: STUDY_DIRECTOR
References: