ObesityNCT00813176
One-Lung Ventilation in the Morbidly Obese Patient: Comparison of Double Lumen Versus Bronchial Blockers
A study testing Double Lumen Endotracheal Tube and Arndt Bronchial Blocker in people with Obesity, run by Javier H Campos at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the double-lumen endotracheal tube or the standard single-lumen tracheal tube, with an Arndt® blocker, is superior in providing one lung ventilation during thoracic surgery. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Obesity
- What is being tested?
- Double Lumen Endotracheal Tube and Arndt Bronchial Blocker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Dec 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject undergoing thoracic or esophageal surgery requiring one-lung ventilation.
- Subject is >18 years of age.
- Subject's BMI > 35.
Who cannot join
- Subject < 18 years of age.
- Subject's BMI < 35.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: One-Lung Ventilation in Morbidly Obese Patients:
The purpose of this study is to determine whether the double-lumen endotracheal tube or the standard single-lumen tracheal tube, with an Arndt® blocker, is superior in providing one lung ventilation during thoracic surgery.
Read the detailed description
The purpose of the study is to compare a double lumen tube versus the standard single-lumen tracheal tube, with an Arndt® blocker, in the morbidly obese patient who requires one-lung ventilation during surgery. The objects is to determine which device is best for intubation and is most effective in terms of optimal positioning of the device, of lung collapse, and quality of lung isolation.
- Conditions
- Obesity
- Being tested
- Double Lumen Endotracheal Tube, Arndt Bronchial Blocker
- Keywords
- Obesity, One-Lung Ventilation, Anesthesia, Thoracic, One-lung ventilation in the morbidly obese patient
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double Lumen Endotracheal TubeDevice
Arndt Bronchial BlockerDevice
| Study group | Role | What they receive |
|---|---|---|
| Double Lumen Endotracheal Tube | Active comparator | We used a device called a double lumen tube ( DLT Broncho-Cath®). It is a bifurcated endotracheal tube designed to independently collapse the operated lung. Receives: Device: Double Lumen Endotracheal Tube |
| Arndt Bronchial Blocker | Active comparator | We used a device called a bronchial blocker (9 Fr Arndt® blocker) along with a standard single-lumen tracheal tube (8.0-9.0 mm ID). The Arndt bronchial blocker is a single device, with a distal balloon that is passed thru the single lumen endotracheal once the patient is intubated. The Arndt bronchial blocker is designed to collapse the operated lung. Receives: Device: Arndt Bronchial Blocker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Taken for Endotracheal Tube Placement Procedure.
For each group, the time in minutes required for the anesthesiologist to successfully place the endotracheal tube.
Intubation time was recorded as the time from when the tracheal tube passed the vocal cords until the anesthetist concluded that the DLT (Arm 1) or the single-lumen tube with the Arndt blocker (Arm 2) was correctly placed and optimal position was confirmed with the fiberoptic bronchoscope.
Measured: This measurement occurred after the patient was in the operating room and the randomization group was determined. This measurement began and ended during the intubation procedure.
Number of Participants in Which the Tube Was Successfully Positioned at First Attempt
Number of participants in each group in which the tube was successfully positioned at first attempt
Measured: This data measure was occurred during surgery.
Secondary outcomes (4)
Effectiveness of Lung Collapse
For each group, the number of participants in which lung collapse was evaluated as: (i) good-complete collapse without surgical interference, (ii) fair-total collapse, but with residual air, and (iii) poor-no or partial collapse, lung inflated and interfering with the surgical exposure.
Measured: This measure occured during surgery just after intubation.
Time Required to Collapse the Lung
For each group, the mean time for lung isolation/collapse was measured from the institution of one-lung ventilation to the time of total lung collapse.
Measured: This measurement occurred during surgery.
Number of Participants With Successful Reinflation
In each group, the number of Participants in which successful lung reinflation occurred.
Measured: This occurred during surgery.
Mean Intraoperative Oxygenation During One-lung Ventilation
For each group, the mean intraoperative oxygenation (arterial partial pressure of oxygen measured by arterial blood gases) were taken during two-lung ventilation (baseline) and after 30 min of one-lung ventilation.
Measured: This measure occured during surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2008 (estimated)
- Study startMar 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective randomized study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Javier H Campos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Javier H Campos, University of Iowa
- Investigators
- Javier H Campos, MD, Principal investigator, Iowa Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00813176
- Sponsor's protocol ID
- 200701755
- Status last verified
- May 2018
- First submitted
- 18 Dec 2008
- Last updated
- 4 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-Lung Ventilation in Morbidly Obese Patients:
- ClinicalTrials.gov ID
- NCT00813176
- Acronym / sponsor ID
- 200701755
- Conditions
- Obesity
- Keywords
- Obesity, One-Lung Ventilation, Anesthesia, Thoracic, One-lung ventilation in the morbidly obese patient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Javier H CamposUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 22 Dec 2008 (estimated)
- Results
- Posted 4 Jun 2018
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 determine whether the double-lumen endotracheal tube or the standard single-lumen tracheal tube, with an Arndt® blocker, is superior in providing one lung ventilation during thoracic surgery.
Detailed description
The purpose of the study is to compare a double lumen tube versus the standard single-lumen tracheal tube, with an Arndt® blocker, in the morbidly obese patient who requires one-lung ventilation during surgery. The objects is to determine which device is best for intubation and is most effective in terms of optimal positioning of the device, of lung collapse, and quality of lung isolation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- prospective randomized study
| Arm | Type | Receives |
|---|---|---|
| Double Lumen Endotracheal Tube | Active comparator | Device: Double Lumen Endotracheal TubeWe used a device called a double lumen tube ( DLT Broncho-Cath®). It is a bifurcated endotracheal tube designed to independently collapse the operated lung. |
| Arndt Bronchial Blocker | Active comparator | Device: Arndt Bronchial BlockerWe used a device called a bronchial blocker (9 Fr Arndt® blocker) along with a standard single-lumen tracheal tube (8.0-9.0 mm ID). The Arndt bronchial blocker is a single device, with a distal balloon that is passed thru the single lumen endotracheal once the patient is intubated. The Arndt bronchial blocker is designed to collapse the operated lung. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject undergoing thoracic or esophageal surgery requiring one-lung ventilation.
- Subject is >18 years of age.
- Subject's BMI > 35.
Key exclusion criteria (2 listed)
- Subject < 18 years of age.
- Subject's BMI < 35.
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 |
|---|---|---|
| Double Lumen Endotracheal Tube | Device | Double Lumen Endotracheal Tube |
| Arndt Bronchial Blocker | Device | Arndt Bronchial Blocker |
Primary outcome
Time Taken for Endotracheal Tube Placement Procedure.
Time frame: This measurement occurred after the patient was in the operating room and the randomization group was determined. This measurement began and ended during the intubation procedure.
For each group, the time in minutes required for the anesthesiologist to successfully place the endotracheal tube. Intubation time was recorded as the time from when the tracheal tube passed the vocal cords until the anesthetist concluded that the DLT (Arm 1) or the single-lumen tube with the Arndt blocker (Arm 2) was correctly placed and optimal position was confirmed with the fiberoptic bronchoscope.
Number of Participants in Which the Tube Was Successfully Positioned at First Attempt
Time frame: This data measure was occurred during surgery.
Number of participants in each group in which the tube was successfully positioned at first attempt
4 secondary outcomes
Effectiveness of Lung Collapse
Time frame: This measure occured during surgery just after intubation.
Time Required to Collapse the Lung
Time frame: This measurement occurred during surgery.
Number of Participants With Successful Reinflation
Time frame: This occurred during surgery.
Mean Intraoperative Oxygenation During One-lung Ventilation
Time frame: This measure occured during surgery.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Javier H Campos, MD principal investigator
Iowa Health Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Double Lumen Endotracheal Tube and Arndt Bronchial Blocker in people with Obesity, run by Javier H Campos at 1 site in United States.
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 2 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 4 Jun 2018. 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 United States. 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?
Yes. Results are posted in the registry (first posted 4 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time Taken for Endotracheal Tube Placement Procedure. (time frame: This measurement occurred after the patient was in the operating room and the randomization group was determined. This measurement began and ended during the intubation procedure.). The study lists 2 primary outcomes in all. 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 4 Jun 2018.