ClinicalTrials.gov
ClinicalTrials.gov Menu

Dead Space Monitoring With Volumetric Capnography in ARDS Patients

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: NCT02889770
Recruitment Status : Completed
First Posted : September 7, 2016
Last Update Posted : September 7, 2016
Sponsor:
Information provided by (Responsible Party):
Emiliano Gogniat, Hospital Italiano de Buenos Aires

Brief Summary:
This studies´ objective is to describe how different PEEP levels affect dead space measured by Bohr´s formula.

Condition or disease Intervention/treatment
Acute Respiratory Distress Syndrome Capnography Other: PEEP titration

Detailed Description:

In ARDS patients PEEP has contradictory effects on ∆P (driving pressure of the airway) hat depends on the balance between lung recruitment and overdistension. Some authors showed that incremental levels of PEEP did not much affect dead space in ARDS patients. These studies used different methods for the assessment of dead space.

Such technique also overestimates the dead space. We believe that the right way to measure dead space is applying the original Bohr's equation using the mean PACO2 value. Therefore, the aim of this observational study was to describe the effect that PEEP has on Bohr's dead space and its sub-components in mechanically ventilated patients with ARDS.

This observational study was performed in the Intensive Care Unit of a University Hospital.

Protocol design The protocol started recording the data during baseline protective ventilation. After 15 minutes of data recording, we studied four levels of PEEP - 0, 6, 10 and 16 cmH2O - which were randomly assigned by a randomization table.

Respiratory, hemodynamic, arterial blood gas analysis and volumetric capnographic parameters were recorded. We analyzed the last 2 minutes of each protocol steps consisting in more than 30 breaths or data-points.


Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dead Space Monitoring During PEEP Titration in Patients With Hypoxemia Secondary to Acute Respiratory Distress Syndrome
Study Start Date : September 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : June 2016



Intervention Details:
  • Other: PEEP titration
    Exposure to different PEEP levels


Primary Outcome Measures :
  1. Dead space variation [ Time Frame: 60 min ]
    How dead space, measured by Bohr´s formula, varies with different PEEP levels during a recruitment manouver



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ARDS patients
Criteria

Inclusion Criteria:

  • age older than 18 years
  • requirement of invasive mechanical ventilation for more than 4 hours and less than 12 hours
  • severe hypoxemia (PAFI < 200) secondary to ARDS or post-operatory atelectasis

Exclusion Criteria:

-requirement of invasive mechanical ventilation prior to enrollment in this study


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02889770


Sponsors and Collaborators
Hospital Italiano de Buenos Aires
Investigators
Principal Investigator: Emiliano Gogniat, PT Hospital Italiano de Buenos Aires

Responsible Party: Emiliano Gogniat, Physical therapist, Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier: NCT02889770     History of Changes
Other Study ID Numbers: 1968
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury