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Efficacy and Safety of a Lung Recruitment Protocol in Children With Acute Lung Injury (Recruitment)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Brian Walsh, Boston Children's Hospital
ClinicalTrials.gov Identifier:
NCT00830284
First received: December 24, 2008
Last updated: December 23, 2016
Last verified: December 2016
Results First Received: December 23, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Acute Respiratory Distress Syndrome
Acute Lung Injury
Intervention: Procedure: Recruitment maneuver

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Recruitment

Patients with hypoxic respiratory failure

Recruitment maneuver: Three types of maneuvers will be performed.

  1. 6cc/kg tidal volumes at an appropiate rate on current prescribed PEEP level.
  2. 6cc/Kg tidal volumes at an appropiate rate following a 40 cmH2O for 40 seconds maneuver returning to a pflex plus 2 cmH2O PEEP level.
  3. PEEP titration starting a 15 cmH2O and increasing in 5 cmH2O increases until the PaO2+PaCO2 is 400 or higher.

Participant Flow:   Overall Study
    Recruitment
STARTED   12 [1] 
COMPLETED   10 
NOT COMPLETED   2 
[1] The study was started in our Medical Surgical ICU October of 2008.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Recruitment

Patients with hypoxic respiratory failure

Recruitment maneuver: Three types of maneuvers will be performed.

  1. 6cc/kg tidal volumes at an appropiate rate on current prescribed PEEP level.
  2. 6cc/Kg tidal volumes at an appropiate rate following a 40 cmH2O for 40 seconds maneuver returning to a pflex plus 2 cmH2O PEEP level.
  3. PEEP titration starting a 15 cmH2O and increasing in 5 cmH2O increases until the PaO2+PaCO2 is 400 or higher.

Baseline Measures
   Recruitment 
Overall Participants Analyzed 
[Units: Participants]
 10 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      10 100.0% 
Between 18 and 65 years      0   0.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 9.35  (2.3) 
Gender 
[Units: Participants]
Count of Participants
 
Female      8  80.0% 
Male      2  20.0% 
Patients had to meet the ALI criteria 
[Units: Participants]
Count of Participants
 10 


  Outcome Measures
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1.  Primary:   PaO2 + PaCO2 of 400 or Higher.   [ Time Frame: 2 hours ]

2.  Secondary:   Safety - Airleak, Cardiac Compromise, Respiratory Acidosis.   [ Time Frame: 4 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Brian Kendall Walsh
Organization: Boston Children's Hospital
phone: 6179193692
e-mail: brian.walsh@childrens.harvard.edu



Responsible Party: Brian Walsh, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT00830284     History of Changes
Other Study ID Numbers: 08-07-0328
Recruitment
Study First Received: December 24, 2008
Results First Received: December 23, 2016
Last Updated: December 23, 2016