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

Primary Purpose

Acute Respiratory Distress Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
SI recruitment
IP recruitment
PCV recruitment
Sponsored by
Southeast University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome focused on measuring ARDS, EIT, recruitment maneuvers

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zhongda hospital, Southeast UniversityRecruiting
  • Zhongda hospital, Southeast UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

SI recruitment

IP recruitment

PCV recruitment

Arm Description

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.

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).

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

Outcomes

Primary Outcome Measures

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%

Secondary Outcome Measures

Full Information

First Posted
February 4, 2015
Last Updated
March 12, 2015
Sponsor
Southeast University, China
Collaborators
Zhongda Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02387437
Brief Title
Different Effects of Three Recruitment Maneuvers on the Lung Heterogeneity of Acute Respiratory Distress Syndrome
Acronym
DEOTRMOARDS
Official Title
Evaluation of Different Effects of Three Recruitment Maneuvers on the Lung Heterogeneity of Acute Respiratory Distress Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southeast University, China
Collaborators
Zhongda Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome
Keywords
ARDS, EIT, recruitment maneuvers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
93 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SI recruitment
Arm Type
Experimental
Arm Description
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.
Arm Title
IP recruitment
Arm Type
Experimental
Arm Description
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).
Arm Title
PCV recruitment
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
SI recruitment
Intervention Description
SI continuous positive airway pressure (CPAP) held at 40 cm H2O for 40 secs.
Intervention Type
Behavioral
Intervention Name(s)
IP recruitment
Intervention Description
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
Intervention Name(s)
PCV recruitment
Intervention Description
PCV peak pressure = 40 cm H2O, inspiratory to expiratory ratio = 1:2, and PEEP level = 15cm H2O for 2 min
Primary Outcome Measure Information:
Title
oxygenation (improvement of oxygenation)
Description
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%
Time Frame
improvement of oxygenation 3 minutes after lung recruiment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yingzi Huang
Organizational Affiliation
southeast univerity, China
Official's Role
Study Director
Facility Information:
Facility Name
Zhongda hospital, Southeast University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chun Pan, Dr
Phone
+862583262550
Email
panchun1982@gmail.com
Facility Name
Zhongda hospital, Southeast University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lihui Wang, Dr
Phone
+861580516055
Email
Lihui_Wang0622@126.com

12. IPD Sharing Statement

Learn more about this trial

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

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