NCT02387437

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 13, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 13, 2015

Status Verified

December 1, 2014

Enrollment Period

1.2 years

First QC Date

February 4, 2015

Last Update Submit

March 12, 2015

Conditions

Acute Respiratory Distress Syndrome

Keywords

ARDSEITrecruitment maneuvers

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

SI recruitment

EXPERIMENTAL

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.

Behavioral: SI recruitmentBehavioral: IP recruitmentBehavioral: PCV recruitment

IP recruitment

EXPERIMENTAL

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).

Behavioral: SI recruitmentBehavioral: IP recruitmentBehavioral: PCV recruitment

PCV recruitment

EXPERIMENTAL

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

Behavioral: SI recruitmentBehavioral: IP recruitmentBehavioral: PCV recruitment

Interventions

SI recruitmentBEHAVIORAL

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

IP recruitmentPCV recruitmentSI recruitment
IP recruitmentBEHAVIORAL

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).

IP recruitmentPCV recruitmentSI recruitment
PCV recruitmentBEHAVIORAL

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

IP recruitmentPCV recruitmentSI recruitment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Zhongda hospital, Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

Zhongda hospital, Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Yingzi Huang

    southeast univerity, China

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

February 4, 2015

First Posted

March 13, 2015

Study Start

November 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

March 13, 2015

Record last verified: 2014-12

Locations

CN(2)