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

NCT ID: NCT02387437

Last Updated: 2015-03-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-01-31

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.

Conditions

Acute Respiratory Distress Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SI recruitment

Compare the effect of three recruitment maneuvers before and after recruitment maneuvers is implemented,SI continuous positive airway pressure (CPAP) held at 40 cm H2O for 40 secs.

Group Type: EXPERIMENTAL

SI recruitment

Intervention Type: BEHAVIORAL

SI continuous positive airway pressure (CPAP) held at 40 cm H2O for 40 secs.

IP recruitment

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

PCV peak pressure = 40 cm H2O, inspiratory to expiratory ratio = 1:2, and PEEP level = 15cm H2O for 2 min

IP recruitment

Compare the effect of three recruitment maneuvers before and after recruitment maneuvers is implemented,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).

Group Type: EXPERIMENTAL

SI recruitment

Intervention Type: BEHAVIORAL

SI continuous positive airway pressure (CPAP) held at 40 cm H2O for 40 secs.

IP recruitment

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

PCV peak pressure = 40 cm H2O, inspiratory to expiratory ratio = 1:2, and PEEP level = 15cm H2O for 2 min

PCV recruitment

Compare the effect of three recruitment maneuvers before and after recruitment maneuvers is implemented,PCV peak pressure = 40 cm H2O, inspiratory to expiratory ratio = 1:2, and PEEP level = 15cm H2O for 2 min

Group Type: EXPERIMENTAL

SI recruitment

Intervention Type: BEHAVIORAL

SI continuous positive airway pressure (CPAP) held at 40 cm H2O for 40 secs.

IP recruitment

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

PCV peak pressure = 40 cm H2O, inspiratory to expiratory ratio = 1:2, and PEEP level = 15cm H2O for 2 min

Interventions

SI recruitment

SI continuous positive airway pressure (CPAP) held at 40 cm H2O for 40 secs.

Intervention Type: BEHAVIORAL

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).

Intervention Type: BEHAVIORAL

PCV recruitment

PCV peak pressure = 40 cm H2O, inspiratory to expiratory ratio = 1:2, and PEEP level = 15cm H2O for 2 min

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhongda Hospital

OTHER

Sponsor Role: collaborator

Southeast University, China

OTHER

Sponsor Role: lead

Responsible Party

Jianfeng Xie

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yingzi Huang

Role: STUDY_DIRECTOR

southeast univerity, China

Locations

Zhongda hospital, Southeast University

Nanjing, Jiangsu, China

Site Status: RECRUITING

Zhongda hospital, Southeast University

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Chun Pan, Dr

Role: primary

panchun1982@gmail.com

+862583262550

Lihui Wang, Dr

Role: primary

Lihui_Wang0622@126.com

+861580516055

Other Identifiers

2014ZDSYLL124.1

Identifier Type: -

Identifier Source: org_study_id