Acute Respiratory Distress SyndromeNCT02889770
Dead Space Monitoring With Volumetric Capnography in ARDS Patients
An observational study of Acute Respiratory Distress Syndrome and Capnography, run by Hospital Italiano de Buenos Aires.
Trial summary
This studies´ objective is to describe how different PEEP levels affect dead space measured by Bohr´s formula. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Capnography
- What is being tested?
- PEEP titration
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ARDS patients
Who may be able to join
- 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
Who cannot join
- -requirement of invasive mechanical ventilation prior to enrollment in this study
About this study
Official title: Dead Space Monitoring During PEEP Titration in Patients With Hypoxemia Secondary to Acute Respiratory Distress Syndrome
This studies´ objective is to describe how different PEEP levels affect dead space measured by Bohr´s formula.
Read the 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.
- Conditions
- Acute Respiratory Distress Syndrome, Capnography
- Being tested
- PEEP titration
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEP titrationOther
Exposure to different PEEP levels
What is being measured
The primary outcome is the main question the study is designed to answer.
Dead space variation
How dead space, measured by Bohr´s formula, varies with different PEEP levels during a recruitment manouver
Measured: 60 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startSep 2013
- Primary completionOct 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emiliano Gogniat, Hospital Italiano de Buenos Aires
- Investigators
- Emiliano Gogniat, PT, Principal investigator, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02889770
- Sponsor's protocol ID
- 1968
- Status last verified
- Sep 2016
- First submitted
- 31 Aug 2016
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dead Space Monitoring During PEEP Titration in Patients With Hypoxemia Secondary to Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT02889770
- Acronym / sponsor ID
- 1968
- Conditions
- Acute Respiratory Distress Syndrome, Capnography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 7 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This studies´ objective is to describe how different PEEP levels affect dead space measured by Bohr´s formula.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ARDS patients
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- -requirement of invasive mechanical ventilation prior to enrollment in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEEP titrationExposure to different PEEP levels | Other | – |
Primary outcome
Dead space variation
Time frame: 60 min
How dead space, measured by Bohr´s formula, varies with different PEEP levels during a recruitment manouver
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emiliano Gogniat, PT principal investigator
Hospital Italiano de Buenos Aires
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome and Capnography, run by Hospital Italiano de Buenos Aires.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dead space variation (time frame: 60 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2016.