Brief Description of Focus of Study InsteadNCT05000814
Study of Cost-effectiveness of the Airway Management in Thoracic Surgery
An observational study of Brief Description of Focus of Study Instead, run by Hospital General Valencia at 1 site in Spain.
Trial summary
The investigators want to carry out a study to determine the role of Doble Lumen Tubes with built-in camera Viva Sight-DL (VDLT) in thoracic surgery. With this study the investigators want to study and enlarge the information in the different surgical approaches, including robotic surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brief Description of Focus of Study Instead
- What is being tested?
- DLT
- Type of treatment
- Medical device
- How many people
- 110 participants
- Where
- 1 siteSpain
- Study dates
- 30 Nov 2023to 1 Feb 2026
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients undergoing lung resection by thoracotomy, VATS or robotic thoracic surgery.
Who may be able to join
- Patients of legal age (≥18 years).
- Patients who require one-lung collapse in Thoracic Surgery procedures.
Who cannot join
- Patients with predicted difficult airway.
- Left main bronchus anomalies.
- Previous thoracic surgery.
- BMI> 40.
- Patients with tracheostomy.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Ruth Martinez Plumed
Valencia, 46007
RUTH MARTINEZ PLUMED, 652678215, RUTH.MARTINEZ.PLUMED@GMAIL.COM
About this study
Official title: Study of Cost-effectiveness of the Airway Management and Pulmonary Isolation in Thoracic Surgery Using Standard Double Lumen Tubes vs VivaSight-DL
The investigators want to carry out a study to determine the role of Doble Lumen Tubes with built-in camera Viva Sight-DL (VDLT) in thoracic surgery. With this study the investigators want to study and enlarge the information in the different surgical approaches, including robotic surgery.
The objective of this study is report a single-center experience using individual data costs to compare the cost effectiveness of VDLT Viva Sight versus the use of conventional Doble Lumen Tubes (cDLT) together with fiberoptic bronchoscope in patients undergoing thoracic surgery, in order to generate information for future decision making related to both devices.
Read the detailed description
The investigators want to carry out a comparative clinical study on the use of conventional double-lumen endobronchial tubes (cDLT) or video double-lumen endobronquial tubes Vivasight DL (VDLT) during intubation in thoracic lung resection surgery, to study their possible advantages and disadvantages.
This will be a prospective, single-center cohort study of Thoracic Surgery in which the VivaSight-DL (n = 55 patients) or conventional DLT (n = 55 patients) is used for lung isolation in elderly patients (≥ 18 years), thoracic surgery procedures of the "lung resection" type: wedge resection, transegmental resection, lobectomy, bilobectomy or pneumectomy by the different surgical approaches: VATS, robotic surgery and thoracotomy.
The objective of this study is to find out if the use of VDLT reduces the need for fiberoptic bronchoscope (FBS) to verify the positioning of the endobronchial tube during intubation and intraoperatively. Reducing the need for FBS could improve the quality of care provided to the patient and reduce costs to the hospital.
- Being tested
- DLT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DLTDevice
VDLT versus the use of DLT with fiberoptic bronchoscope
| Study group | Role | What they receive |
|---|---|---|
| cDLT | patients using conventional double lumen tube for thoracic surgery Receives: Device: DLT | |
| VDLT | patients using Vivasight DLT for thoracic surgery Receives: Device: DLT |
What is being measured
The primary outcome is the main question the study is designed to answer.
VDLT reduces the use of fiberoptic bronchoscope
Determine if the use of VivaSight-DL® for lung isolation during lung resections is associated with less need for the use of fiberoptic bronchoscope to check the patient's airway during Thoracic Surgery compared to a conventional double-lumen tube.The cases where VDLT is used and the fiberoptic bronchoscope is necessary will be quantified.
Measured: 4 years
Costs associated with the use of VDLT
- Cost of airway material: includes the use of cDLT as well as the use or not of fiberoptic bronchoscope. The costs of maintenance and cleaning of the same will be included.
- Cost of the surgical intervention taking the cost / minute of thoracic surgery. Surgeon and surgical assistant, an anesthesiologist, three nurses, a clinic assistant and a caretaker work in these operating rooms. These last two professionals are shared with other operating rooms in the surgical area.
- Cost of stays in hospitalization room / ICU.
Measured: 4 years
Costs associated with the use of cDLT and fiberoptic bronchoscope
- Cost of airway material: includes the use of cDLT as well as the use or not of fiberoptic bronchoscope. The costs of maintenance and cleaning of the same will be included.
- Cost of the surgical intervention taking the cost / minute of thoracic surgery. Surgeon and surgical assistant, an anesthesiologist, three nurses, a clinic assistant and a caretaker work in these operating rooms. These last two professionals are shared with other operating rooms in the surgical area.
- Cost of stays in hospitalization room / ICU.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start30 Nov 2023 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brief Description of Focus of Study InsteadStudies 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
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruth Martinez Plumed, Hospital General Valencia
- Investigators
- Ruth Martinez Plumed, Principal investigatorManuel Granell Gil, Principal investigator, Professor, Spanish Society of Anesthesia and Critical Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000814
- Sponsor's protocol ID
- 2021
- Status last verified
- Nov 2023
- First submitted
- 13 Apr 2021
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Cost-effectiveness of the Airway Management and Pulmonary Isolation in Thoracic Surgery Using Standard Double Lumen Tubes vs VivaSight-DL
- ClinicalTrials.gov ID
- NCT05000814
- Acronym / sponsor ID
- 2021
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Hospital General ValenciaUniversity, hospital or other
- Study start
- 30 Nov 2023 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 11 Aug 2021 (actual)
- 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 investigators want to carry out a study to determine the role of Doble Lumen Tubes with built-in camera Viva Sight-DL (VDLT) in thoracic surgery. With this study the investigators want to study and enlarge the information in the different surgical approaches, including robotic surgery.
The objective of this study is report a single-center experience using individual data costs to compare the cost effectiveness of VDLT Viva Sight versus the use of conventional Doble Lumen Tubes (cDLT) together with fiberoptic bronchoscope in patients undergoing thoracic surgery, in order to generate information for future decision making related to both devices.
Detailed description
The investigators want to carry out a comparative clinical study on the use of conventional double-lumen endobronchial tubes (cDLT) or video double-lumen endobronquial tubes Vivasight DL (VDLT) during intubation in thoracic lung resection surgery, to study their possible advantages and disadvantages.
This will be a prospective, single-center cohort study of Thoracic Surgery in which the VivaSight-DL (n = 55 patients) or conventional DLT (n = 55 patients) is used for lung isolation in elderly patients (≥ 18 years), thoracic surgery procedures of the "lung resection" type: wedge resection, transegmental resection, lobectomy, bilobectomy or pneumectomy by the different surgical approaches: VATS, robotic surgery and thoracotomy.
The objective of this study is to find out if the use of VDLT reduces the need for fiberoptic bronchoscope (FBS) to verify the positioning of the endobronchial tube during intubation and intraoperatively. Reducing the need for FBS could improve the quality of care provided to the patient and reduce costs to the hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cDLT | – | Device: DLTpatients using conventional double lumen tube for thoracic surgery |
| VDLT | – | Device: DLTpatients using Vivasight DLT for thoracic surgery |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing lung resection by thoracotomy, VATS or robotic thoracic surgery.
Key inclusion criteria (2 listed)
- Patients of legal age (≥18 years).
- Patients who require one-lung collapse in Thoracic Surgery procedures.
Key exclusion criteria (5 listed)
- Patients with predicted difficult airway.
- Left main bronchus anomalies.
- Previous thoracic surgery.
- BMI> 40.
- Patients with tracheostomy.
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 |
|---|---|---|
| DLTVDLT versus the use of DLT with fiberoptic bronchoscope | Device | VDLT, cDLT |
Primary outcome
VDLT reduces the use of fiberoptic bronchoscope
Time frame: 4 years
Determine if the use of VivaSight-DL® for lung isolation during lung resections is associated with less need for the use of fiberoptic bronchoscope to check the patient's airway during Thoracic Surgery compared to a conventional double-lumen tube.The cases where VDLT is used and the fiberoptic bronchoscope is necessary will be quantified.
Costs associated with the use of VDLT
Time frame: 4 years
* Cost of airway material: includes the use of cDLT as well as the use or not of fiberoptic bronchoscope. The costs of maintenance and cleaning of the same will be included. * Cost of the surgical intervention taking the cost / minute of thoracic surgery. Surgeon and surgical assistant, an anesthesiologist, three nurses, a clinic assistant and a caretaker work in these operating rooms. These last two professionals are shared with other operating rooms in the surgical area. * Cost of stays in hospitalization room / ICU.
Costs associated with the use of cDLT and fiberoptic bronchoscope
Time frame: 4 years
* Cost of airway material: includes the use of cDLT as well as the use or not of fiberoptic bronchoscope. The costs of maintenance and cleaning of the same will be included. * Cost of the surgical intervention taking the cost / minute of thoracic surgery. Surgeon and surgical assistant, an anesthesiologist, three nurses, a clinic assistant and a caretaker work in these operating rooms. These last two professionals are shared with other operating rooms in the surgical area. * Cost of stays in hospitalization room / ICU.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available.
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.
Ruth Martinez Plumed principal investigator
Manuel Granell Gil principal investigator
Professor, Spanish Society of Anesthesia and Critical Care
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 Brief Description of Focus of Study Instead, run by Hospital General Valencia at 1 site in Spain.
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 2 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: status not confirmed, as of the sponsor's last update on 18 Nov 2023. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruth Martinez Plumed, Medicine (34652678215, ruth.martinez.plumed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VDLT reduces the use of fiberoptic bronchoscope (time frame: 4 years). The study lists 3 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 18 Nov 2023.