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Trial record 15 of 645 for:    Russian Federation | Chile

Third International Study on Mechanical Ventilation (ISMV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01093482
Recruitment Status : Completed
First Posted : March 25, 2010
Results First Posted : January 26, 2018
Last Update Posted : March 1, 2018
Sponsor:
Information provided by (Responsible Party):
Andres Esteban, Hospital Universitario Getafe

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Acute Respiratory Failure
Enrollment 8151
Recruitment Details Consecutive patients who required mechanical ventilation for more than 12 hours in the participating intensive care units.
Pre-assignment Details  
Arm/Group Title Mechanically Ventilated Patients
Hide Arm/Group Description
  1. Patients who are admitted to the participating intensive care units and require invasive mechanical ventilation (endotracheal tube or tracheostomy) for more than 12 hours.
  2. Patients who are admitted to the participating intensive care units and require non-invasive mechanical ventilation (Bilevel positive airway pressure (BIPAP) or continuous positive airway pressure (CPAP) with nasal or facial mask) for more than 1 hour.
Period Title: Overall Study
Started 8151
Completed 8151
Not Completed 0
Arm/Group Title Mechanically Ventilated Patients
Hide Arm/Group Description
  1. Patients who are admitted to the participating intensive care units and require invasive mechanical ventilation (endotracheal tube or tracheostomy) for more than 12 hours.
  2. Patients who are admitted to the participating intensive care units and require non-invasive mechanical ventilation (Bilevel positive airway pressure (BIPAP) or continuous positive airway pressure (CPAP) with nasal or facial mask) for more than 1 hour.
Overall Number of Baseline Participants 8151
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8151 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4233
  51.9%
>=65 years
3918
  48.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8151 participants
61  (18)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8151 participants
Female
3105
  38.1%
Male
5046
  61.9%
1.Primary Outcome
Title All-cause Mortality
Hide Description Mortality at discharge from intensive care unit
Time Frame At day 28 after the beginning of mechanical ventilation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mechanically Ventilated Patients
Hide Arm/Group Description:
  1. Patients who are admitted to the participating intensive care units and require invasive mechanical ventilation (endotracheal tube or tracheostomy) for more than 12 hours.
  2. Patients who are admitted to the participating intensive care units and require non-invasive mechanical ventilation (Bilevel positive airway pressure (BIPAP) or continuous positive airway pressure (CPAP) with nasal or facial mask) for more than 1 hour.
Overall Number of Participants Analyzed 8151
Measure Type: Count of Participants
Unit of Measure: Participants
2269
  27.8%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mechanically Ventilated Patients
Hide Arm/Group Description
  1. Patients who are admitted to the participating intensive care units and require invasive mechanical ventilation (endotracheal tube or tracheostomy) for more than 12 hours.
  2. Patients who are admitted to the participating intensive care units and require non-invasive mechanical ventilation (Bilevel positive airway pressure (BIPAP) or continuous positive airway pressure (CPAP) with nasal or facial mask) for more than 1 hour.
All-Cause Mortality
Mechanically Ventilated Patients
Affected / at Risk (%)
Total   2269/8151 (27.84%) 
Show Serious Adverse Events Hide Serious Adverse Events
Mechanically Ventilated Patients
Affected / at Risk (%)
Total   0/8151 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Mechanically Ventilated Patients
Affected / at Risk (%)
Total   0/8151 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Andres Esteban
Organization: VENTILA group
Phone: 34916834982
EMail: aesteban@ucigetafe.com
Layout table for additonal information
Responsible Party: Andres Esteban, Hospital Universitario Getafe
ClinicalTrials.gov Identifier: NCT01093482     History of Changes
Other Study ID Numbers: ISMV-2010
First Submitted: March 23, 2010
First Posted: March 25, 2010
Results First Submitted: February 27, 2017
Results First Posted: January 26, 2018
Last Update Posted: March 1, 2018