Anesthesia, Cost-effectiveness, Single Lung Ventilation, Thoracic Surgery
Conditions
Brief summary
The aim of this study is to make a health economic evaluation comparing novice physicians use of VivaSight double-lumen tube and a conventional double-lumen tube for single-lung ventilation during thoracic surgery at a teaching hospital. The hypothesis is, that both double-lumen tubes are equally cost-effective and the the incidence of fiberoptic bronchoscope use it the same for both tubes.
Detailed description
A randomized, controlled single-centre investigation comparing the VivaSight double-lumen tube and the conventional double-lumen tube at a teaching hospital. A pilot study including up to 10 subjects will be performed prior to the investigation is initiated. The investigation will include a total of 50 adult subjects (25 subjects in each group) admitted to the investigational site with established indication of single lung ventilation. The objective of the investigation is to compare the number of times the tube position needs to be verified with a scope and relevant costs between VivaSight double lumen tube and conventional double lument tube in a cost-effectiveness analysis.
Interventions
PROCEDUREVivaSight double-lumen tube for single-lung ventilation
Procedure using a tube with a camera
PROCEDUREConventional double-lument tube for single-lung ventilation
Procedure using a tube without a camera
Sponsors
Ambu A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Oral explanation of the investigation and Patient Information has been given to the subject or legal representative * The subject or legal representative has signed the Informed Consent * The subject is admitted at Odense University Hospital (OUH), department V * Subjects evaluated as eligible for single-lung ventilation with the use of a left sided DLT * Subjects \> 18 years of age
Exclusion criteria
* Subjects with known tracheobronchial anatomic anomalies * Subjects going for emergency procedures * Subjects with anticipated difficult airways * Subjects with known tracheal pathology * Subjects requiring rapid sequence induction * Surgeries in which other lung isolation devices or techniques may be warranted (e.g. tracheostomy, nasal intubation, bronchial blockers) * Subjects who cannot be intubated with a double-lumen tube (VivaSight-DL or conventional DLT) * Subjects requiring a right-sided DLT * Subjects who had participated in the study before
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Times Bronchoscope is Used | During procedure, up to 4 hours |
Secondary
| Measure | Time frame |
|---|---|
| Intubation Time | During procedure, up to 4 hours |
| Number of Intubation Attempts | During procedure, up to 4 hours |
| Number of Time the Tube Was Repositioned | During procedure, up to 4 hours |
| Number of Times Repositioning of the Tube Was Prevented | During procedure, up to 4 hours |
| Cost Per Procedure | An average of 1 year |
Other
| Measure | Time frame | Description |
|---|---|---|
| Obtain User Perspective of the Device (VivaSight Double Lumen Tube or Conventional Double Lumen Tube) Used During Procedure. | During procedure, up to 4 hours | Qualitative assessment (face-validated and testet during pilot test) using a five-point scale (1: very easy/very good, 3: acceptable, 5: very difficult/very poor) |
| Patient Reported Post Operative Outcomes | Within 48 hours after the procedure | Qualitative assessment (face-validated and testet during pilot test) using a questionnaire registrering postoperative outcomes (Yes/No) and degree of postoperative outcomes (mild/moderate/severe) |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VivaSight Double-lumen Tube VivaSight double-lumen tube for single-lung ventilation: Procedure using a tube with a camera | 30 |
| Conventional Double-lumen Tube Conventional double-lument tube for single-lung ventilation: Procedure using a tube without a camera | 22 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Drop out | 5 | 12 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | VivaSight Double-lumen Tube | Conventional Double-lumen Tube | Total |
|---|---|---|---|
| Age, Continuous | 65.80 years STANDARD_DEVIATION 10.02 | 68.50 years STANDARD_DEVIATION 7.16 | 66.94 years STANDARD_DEVIATION 8.94 |
| Height | 172.47 cm STANDARD_DEVIATION 9.32 | 172.77 cm STANDARD_DEVIATION 9.56 | 172.60 cm STANDARD_DEVIATION 9.33 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 13 Participants | 12 Participants | 25 Participants |
| Sex: Female, Male Male | 17 Participants | 10 Participants | 27 Participants |
| Surgical lung Left | 9 Participants | 4 Participants | 13 Participants |
| Surgical lung Right | 21 Participants | 18 Participants | 39 Participants |
| Weight | 74.73 kg STANDARD_DEVIATION 19.14 | 76.23 kg STANDARD_DEVIATION 17.12 | 75.37 kg STANDARD_DEVIATION 18.15 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 22 |
| other Total, other adverse events | 0 / 30 | 0 / 22 |
| serious Total, serious adverse events | 0 / 30 | 0 / 22 |
Outcome results
Primary
Number of Times Bronchoscope is Used
Time frame: During procedure, up to 4 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VivaSight Double-lumen Tube | Number of Times Bronchoscope is Used | 0.07 Reported uses of bronchoscopes | Standard Deviation 0.25 |
| Conventional Double-lumen Tube | Number of Times Bronchoscope is Used | 3.14 Reported uses of bronchoscopes | Standard Deviation 1.58 |
Secondary
Cost Per Procedure
Time frame: An average of 1 year
Secondary
Intubation Time
Time frame: During procedure, up to 4 hours
Secondary
Number of Intubation Attempts
Time frame: During procedure, up to 4 hours
Secondary
Number of Times Repositioning of the Tube Was Prevented
Time frame: During procedure, up to 4 hours
Secondary
Number of Time the Tube Was Repositioned
Time frame: During procedure, up to 4 hours
Other Pre-specified
Obtain User Perspective of the Device (VivaSight Double Lumen Tube or Conventional Double Lumen Tube) Used During Procedure.
Qualitative assessment (face-validated and testet during pilot test) using a five-point scale (1: very easy/very good, 3: acceptable, 5: very difficult/very poor)
Time frame: During procedure, up to 4 hours
Other Pre-specified
Patient Reported Post Operative Outcomes
Qualitative assessment (face-validated and testet during pilot test) using a questionnaire registrering postoperative outcomes (Yes/No) and degree of postoperative outcomes (mild/moderate/severe)
Time frame: Within 48 hours after the procedure