Different Effects of Three Recruitment Maneuvers on the Lung Heterogeneity of Acute Respiratory Distress Syndrome

Acute Respiratory Distress Syndrome Clinical Trial

— DEOTRMOARDS  

Official title:

Evaluation of Different Effects of Three Recruitment Maneuvers on the Lung Heterogeneity of Acute Respiratory Distress Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02387437
• Other study ID #: 2014ZDSYLL124.1
• Status: Recruiting
• Phase: N/A
• First received: February 4, 2015
• Last updated: March 12, 2015
• Start date: November 2014
• Est. completion date: January 2016

Study information

• Verified date: December 2014
• Source: Southeast University, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 93
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• SI recruitment
SI continuous positive airway pressure (CPAP) held at 40 cm H2O for 40 secs.
• IP recruitment
Incremental positive end-expiratory pressure (PEEP) with a fixed peak pressure (IP), PEEP increased in 5 cm H2O increments (allowing 30 secs/step) from a baseline PEEP of post-trial to 40 cm H2O while decreasing tidal volume to limit peak inspiratory pressure to 40 cm H2O. After CPAP of 40 cm H2O was held for 30 secs, PEEP was decremented in 5-cm H2O steps to the post-RM PEEP setting, while increasing tidal volume toward the baseline value of 10 mL/kg (as the 40 cm H2O peak pressure limit allowed).
• PCV recruitment
PCV peak pressure = 40 cm H2O, inspiratory to expiratory ratio = 1:2, and PEEP level = 15cm H2O for 2 min

Locations

Country	Name	City	State
China	Zhongda hospital, Southeast University	Nanjing	Jiangsu
China	Zhongda hospital, Southeast University	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Southeast University, China	Zhongda Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oxygenation (improvement of oxygenation)	detection of index 3 minutes after lung recruiment (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%	improvement of oxygenation 3 minutes after lung recruiment	Yes