Mechanical Ventilation ComplicationAIRTHORNCT02361983
Airway Management in Thoracic Anesthesia in Italy
An observational study of Mechanical Ventilation Complication, run by Azienda Ospedaliera S. Maria della Misericordia at 1 site in Italy.
Trial summary
The aim of this study is to evaluate the positioning time and the malpositioning rate of DLTs and BBs, the degree of difficulty perceived in device positioning, the use of bronchoscopy (BRO), and the quality of lung collapse achieved during ONE LUNG VENTILATION. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Mechanical Ventilation Complication
- What is being tested?
- Double lumen tube and Bronchial blocker
- Type of treatment
- Medical device
- How many people
- 2,225 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2012to Dec 2014
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing thoracic surgery
Who may be able to join
- patients who need one lung ventilation undergoing thoracic surgery
Who cannot join
- age < 18 years old
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Anesthesia and Intensive Care
Udine, Udine/Italy, 33100
About this study
Official title: Airway Management in Thoracic Surgery and Incidence Rate of Dislocation and Related Intraoperative Hypoxemia: State of the Art in Italy
The aim of this study is to evaluate the positioning time and the malpositioning rate of DLTs and BBs, the degree of difficulty perceived in device positioning, the use of bronchoscopy (BRO), and the quality of lung collapse achieved during ONE LUNG VENTILATION.
Read the detailed description
Safety and efficacy of the double-lumen tubes (DLT) and bronchial blockers (BB) for lung isolation in patients undergoing thoracic surgery have been extensively studied and most of the results show similar rates of successful placement and lung collapse. DLT and BB are more frequently inserted by anesthetists who are expert in thoracic anesthesia, with dedicated but different training.
The first objective of this study was to evaluate the positioning time and the malpositioning rate of DLTs and BBs, the degree of difficulty perceived in device positioning, the use of bronchoscopy (BRO), and the quality of lung collapse achieved during OLV.
A prospective observational study was designed. To check the optimal DLT (Broncho-Cath Covidien, Ireland, Dublin, Teleflex Medical, Athlone, Irelanad) and/or BB (Uniblocker, Phycon, Fuji, Japan Arndt Cohen Cook, Australia), placement a fiberoptic bronchoscope (FOB) was used. The lung collapse was assessed by surgeons.
Time from laringoscopy to the correct placement of the device, confirmed with FOB, was checked.
Data were analyzed with Student't Test and Chi-square test; p value < 0.05 was considered to be significant.
- Conditions
- Mechanical Ventilation Complication
- Being tested
- Double lumen tube, Bronchial blocker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double lumen tubeDevice
Also called DLT
Patients managed with a double lumen tube for one lung ventilation
Bronchial blockerDevice
Also called BB
Patients managed with a bronchial blocker for one lung ventilation
| Study group | Role | What they receive |
|---|---|---|
| DLT | Patients managed with a Double lumen tube (DLT) Receives: Device: Double lumen tube | |
| Bronchial blockers | Patients managed with a Bronchial blocker (BB) Receives: Device: Bronchial blocker |
What is being measured
The primary outcome is the main question the study is designed to answer.
DOUBLE LUMEN TUBE AND BRONCHIAL BLOCKER POSITIONING SUCCESS RATE: RESIDENTS vs. ATTENDING ANESTHETISTS.
A prospective randomized trial was designed. To check the optimal DLT (Broncho-Cath Covidien, Ireland, Dublin, Teleflex Medical, Athlone, Irelanad) and/or BB (Uniblocker, Phycon, Fuji, Japan Arndt Cohen Cook, Australia), placement a fiberoptic bronchoscope (FOB) was used. The lung collapse was assessed by surgeons.
Time from laringoscopy to the correct placement of the device, confirmed with FOB, was checked.
Data were analyzed with Student't Test and Chi-square test; p value < 0.05 was considered to be significant.
Measured: 11/19/2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2015 (estimated)
- Study startJul 2012
- Primary completionNov 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mechanical Ventilation ComplicationStudies 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
- 2,225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera S. Maria della Misericordia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giorgio Della Rocca, Azienda Ospedaliera S. Maria della Misericordia
- Investigators
- Giorgio Della Rocca, prof, Principal investigator, AOU Santa maria della Misericordia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361983
- Sponsor's protocol ID
- AirwaysThor
- Other IDs
- Local ethics committee ALI01
- Acronym
- AIRTHOR
- Status last verified
- Sep 2025
- First submitted
- 3 Dec 2012
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Narayanaswamy M, McRae K, Slinger P, Dugas G, Kanellakos GW, Roscoe A, Lacroix M. Choosing a lung isolation device for thoracic surgery: a randomized trial of three bronchial blockers versus double-lumen tubes. Anesth Analg. 2009 Apr;108(4):1097-101. doi: 10.1213/ane.0b013e3181999339.
PubMed 19299767Campos JH, Hallam EA, Ueda K. Training in placement of the left-sided double-lumen tube among non-thoracic anaesthesiologists: intubation model simulator versus computer-based digital video disc, a randomised controlled trial. Eur J Anaesthesiol. 2011 Mar;28(3):169-74. doi: 10.1097/EJA.0b013e328340c332.
PubMed 21088594
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Management in Thoracic Surgery and Incidence Rate of Dislocation and Related Intraoperative Hypoxemia: State of the Art in Italy
- ClinicalTrials.gov ID
- NCT02361983
- Acronym / sponsor ID
- AIRTHOR / AirwaysThor
- Conditions
- Mechanical Ventilation Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,225 participants (actual)
- Lead sponsor
- Azienda Ospedaliera S. Maria della MisericordiaUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 12 Feb 2015 (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 aim of this study is to evaluate the positioning time and the malpositioning rate of DLTs and BBs, the degree of difficulty perceived in device positioning, the use of bronchoscopy (BRO), and the quality of lung collapse achieved during ONE LUNG VENTILATION.
Detailed description
Safety and efficacy of the double-lumen tubes (DLT) and bronchial blockers (BB) for lung isolation in patients undergoing thoracic surgery have been extensively studied and most of the results show similar rates of successful placement and lung collapse. DLT and BB are more frequently inserted by anesthetists who are expert in thoracic anesthesia, with dedicated but different training.
The first objective of this study was to evaluate the positioning time and the malpositioning rate of DLTs and BBs, the degree of difficulty perceived in device positioning, the use of bronchoscopy (BRO), and the quality of lung collapse achieved during OLV.
A prospective observational study was designed. To check the optimal DLT (Broncho-Cath Covidien, Ireland, Dublin, Teleflex Medical, Athlone, Irelanad) and/or BB (Uniblocker, Phycon, Fuji, Japan Arndt Cohen Cook, Australia), placement a fiberoptic bronchoscope (FOB) was used. The lung collapse was assessed by surgeons.
Time from laringoscopy to the correct placement of the device, confirmed with FOB, was checked.
Data were analyzed with Student't Test and Chi-square test; p value < 0.05 was considered to be significant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DLT | – | Device: Double lumen tubePatients managed with a Double lumen tube (DLT) |
| Bronchial blockers | – | Device: Bronchial blockerPatients managed with a Bronchial blocker (BB) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing thoracic surgery
Key inclusion criteria (1 listed)
- patients who need one lung ventilation undergoing thoracic surgery
Key exclusion criteria (1 listed)
- age < 18 years old
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 tubeAlso: DLTPatients managed with a double lumen tube for one lung ventilation | Device | DLT |
| Bronchial blockerAlso: BBPatients managed with a bronchial blocker for one lung ventilation | Device | Bronchial blockers |
Primary outcome
DOUBLE LUMEN TUBE AND BRONCHIAL BLOCKER POSITIONING SUCCESS RATE: RESIDENTS vs. ATTENDING ANESTHETISTS.
Time frame: 11/19/2012
A prospective randomized trial was designed. To check the optimal DLT (Broncho-Cath Covidien, Ireland, Dublin, Teleflex Medical, Athlone, Irelanad) and/or BB (Uniblocker, Phycon, Fuji, Japan Arndt Cohen Cook, Australia), placement a fiberoptic bronchoscope (FOB) was used. The lung collapse was assessed by surgeons. Time from laringoscopy to the correct placement of the device, confirmed with FOB, was checked. Data were analyzed with Student't Test and Chi-square test; p value < 0.05 was considered to be significant.
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 1 Oct 2025.
- Results publication: PubMed 19299767Narayanaswamy M, McRae K, Slinger P, Dugas G, Kanellakos GW, Roscoe A, Lacroix M. Choosing a lung isolation device for thoracic surgery: a randomized trial of three bronchial blockers versus double-lumen tubes. Anesth Analg. 2009 Apr;108(4):1097-101. doi: 10.1213/ane.0b013e3181999339.
- Results publication: PubMed 21088594Campos JH, Hallam EA, Ueda K. Training in placement of the left-sided double-lumen tube among non-thoracic anaesthesiologists: intubation model simulator versus computer-based digital video disc, a randomised controlled trial. Eur J Anaesthesiol. 2011 Mar;28(3):169-74. doi: 10.1097/EJA.0b013e328340c332.
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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.
Giorgio Della Rocca, prof principal investigator
AOU Santa maria della Misericordia
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 Mechanical Ventilation Complication, run by Azienda Ospedaliera S. Maria della Misericordia at 1 site in Italy.
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 1 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 1 Oct 2025. 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 Italy. 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?
DOUBLE LUMEN TUBE AND BRONCHIAL BLOCKER POSITIONING SUCCESS RATE: RESIDENTS vs. ATTENDING ANESTHETISTS. (time frame: 11/19/2012). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02361983, which also lists 2 linked publications.
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 1 Oct 2025.