Acute Respiratory Distress SyndromeNCT01078831
Intrabronchial Airway Pressures in Intubated Patients During Bronchoscopy
An observational study of Acute Respiratory Distress Syndrome and Acute Lung Injury (ALI), run by Oslo University Hospital at 1 site in Norway.
Trial summary
The purpose of this study is to examine changes in ventilation and airway pressures during conventional bronchoscopy of intubated patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Acute Lung Injury (ALI)
- What is being tested?
- Bronchoscopy
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2002to Apr 2010
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ARDS/ALI patients on mechanical ventilation where a therapeutic or diagnostic bronchoscopy has been requested by the staff physician.
Who may be able to join
- ARDS/ALI patients on mechanical ventilation
- endotracheal tube size 7-9mm
- age > 18 years
- therapeutic or diagnostic bronchoscopy requested by staff physician
Who cannot join
- SpO2 < 90%
- unstable BP
- pneumothorax
- acute cardiovascular disease
- cerebrovascular or other condition that requires stable BP and saturation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intrabronchial Airway Pressures in Intubated Patients During Bronchoscopy Under Volume Controlled (VC) and Pressure Controlled (PC) Ventilation
The purpose of this study is to examine changes in ventilation and airway pressures during conventional bronchoscopy of intubated patients.
Read the detailed description
Mechanically ventilated patients often need bronchoscopy as a diagnostic procedure or for visually directed elimination of secretions. Partial endotracheal tube occlusion by the bronchoscope increases airflow resistance. Inhibition of inspiratory flow may be compensated for by augmented inspiratory pressure. Reduced expiratory flow however, cannot be compensated for by most ventilators and could lead to higher airway - and intrathoracic pressures that are not detected by pressure transducers in the ventilator tubing. In this study we compare changes in ventilation, airway pressures, ventilator pressures and blood gases during bronchoscopy of intubated patients in both volume controlled and pressure controlled ventilation. Our hypothesis are that 1) increased resistance in the tube during bronchoscopy leads to high intrabronchial airway pressures when the ventilator is in volume controlled mode, and 2) when the ventilator is in pressure controlled mode, increased resistance in the tube during bronchoscopy leads to reduced Tidal Volume and moderately increased paCO2.
- Being tested
- Bronchoscopy
- Medical subject headings
- Respiratory Distress Syndrome, Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BronchoscopyOther
Airway pressures, ventilation changes and blood gas changes are recorded in a group of intubated patients on mechanical ventilation before and after bronchoscope insertion. The registration is done immediately before a therapeutic/diagnostic bronchoscopy requested by a staff physician not involved n the study.
| Study group | Role | What they receive |
|---|---|---|
| ARDS / ALI patients | Not described Receives: Other: Bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in ventilation, airway pressures and blood gases after bronchoscope insertion.
paO2, paCO2 (kPa), airway and ventilator pressures (cmH2O)
Measured: 2 minutes after bronchoscope insertion/ mode change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2010 (estimated)
- Study startMar 2002
- Primary completionApr 2010
- Study completionApr 2010
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.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Helge Opdahl, MD, PhD, Study director, Oslo University Hospital - Ulleval, NorwayOle H Skjønsberg, MD, PhD, Study director, Ullevaal University HospitalFredrik Borchsenius, MD, Study director, Ullevaal University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01078831
- Sponsor's protocol ID
- REK-HO Ref 191-01055, 03052001
- Status last verified
- Nov 2010
- First submitted
- 1 Mar 2010
- Last updated
- 11 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrabronchial Airway Pressures in Intubated Patients During Bronchoscopy Under Volume Controlled (VC) and Pressure Controlled (PC) Ventilation
- ClinicalTrials.gov ID
- NCT01078831
- Acronym / sponsor ID
- REK-HO Ref 191-01055, 03052001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Mar 2002
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 2 Mar 2010 (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.
The purpose of this study is to examine changes in ventilation and airway pressures during conventional bronchoscopy of intubated patients.
Detailed description
Mechanically ventilated patients often need bronchoscopy as a diagnostic procedure or for visually directed elimination of secretions. Partial endotracheal tube occlusion by the bronchoscope increases airflow resistance. Inhibition of inspiratory flow may be compensated for by augmented inspiratory pressure. Reduced expiratory flow however, cannot be compensated for by most ventilators and could lead to higher airway - and intrathoracic pressures that are not detected by pressure transducers in the ventilator tubing. In this study we compare changes in ventilation, airway pressures, ventilator pressures and blood gases during bronchoscopy of intubated patients in both volume controlled and pressure controlled ventilation. Our hypothesis are that 1) increased resistance in the tube during bronchoscopy leads to high intrabronchial airway pressures when the ventilator is in volume controlled mode, and 2) when the ventilator is in pressure controlled mode, increased resistance in the tube during bronchoscopy leads to reduced Tidal Volume and moderately increased paCO2.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARDS / ALI patients | – | Other: Bronchoscopy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ARDS/ALI patients on mechanical ventilation where a therapeutic or diagnostic bronchoscopy has been requested by the staff physician.
Key inclusion criteria (4 listed)
- ARDS/ALI patients on mechanical ventilation
- endotracheal tube size 7-9mm
- age > 18 years
- therapeutic or diagnostic bronchoscopy requested by staff physician
Key exclusion criteria (5 listed)
- SpO2 < 90%
- unstable BP
- pneumothorax
- acute cardiovascular disease
- cerebrovascular or other condition that requires stable BP and saturation
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 |
|---|---|---|
| BronchoscopyAirway pressures, ventilation changes and blood gas changes are recorded in a group of intubated patients on mechanical ventilation before and after bronchoscope insertion. The registration is done immediately before a therapeutic/diagnostic bronchoscopy requested by a staff physician not involved n the study. | Other | ARDS / ALI patients |
Primary outcome
Changes in ventilation, airway pressures and blood gases after bronchoscope insertion.
Time frame: 2 minutes after bronchoscope insertion/ mode change
paO2, paCO2 (kPa), airway and ventilator pressures (cmH2O)
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 11 Nov 2010.
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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.
Helge Opdahl, MD, PhD study director
Oslo University Hospital - Ulleval, Norway
Ole H Skjønsberg, MD, PhD study director
Ullevaal University Hospital
Fredrik Borchsenius, MD study director
Ullevaal University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome and Acute Lung Injury (ALI), run by Oslo University Hospital at 1 site in Norway.
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 4 inclusion and 5 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 11 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Changes in ventilation, airway pressures and blood gases after bronchoscope insertion. (time frame: 2 minutes after bronchoscope insertion/ mode change). 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 11 Nov 2010.