VentilationFlowjetNCT06063798
Respiratory Effects of Flow-Controlled Ventilation and Jet Ventilation in Patients Undergoing Laryngotracheal Surgery
A study testing General anesthesia for laryngotracheal surgery, Mechanical ventilation by FCV and Mechanical ventilation by HFJV in people with Ventilation and Lung Function, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
Laryngotracheal surgery often requires a small diameter endotracheal tube to oxygenate patients under general anesthesia. Oxygenation is often only possible with high-frequency jet ventilators due to the use of small diameter and high resistance airway cannulas. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Ventilation, Lung Function, Anesthesia, General
- What is being tested?
- General anesthesia for laryngotracheal surgery, Mechanical ventilation by FCV and Mechanical ventilation by HFJV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 Sep 2023to Dec 2025
- Phase
- Interventional
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed Consent signed by the subject
- General anesthesia for laryngotracheal surgery
- Adult patients, female and male, over 18 years of age
- Elective surgery
Who cannot join
- Documented severe heart conditions (New York Heart Association Class 4, severe pulmonary hypertension)
- Documented severe respiratory disease (uncontrolled asthma, severe pulmonary fibrosis, chronic obstructive pulmonary disease GOLD 4)
- Documented severe Neurological diseases (Acute ischemic and hemorrhagic stroke within the preceding 3 months, uncontrolled seizures)
- Surgery that requires tracheotomy
- Obesity (Body Mass Index ≥ 30 kg/m2)
- Inability to follow the procedures of the study (mental condition or language barrier e.g. incomprehension of French language)
- Previous enrolment into the current study or other study that involves unknown medication in the past 12 months
- Allergy or contraindication to Propofol and/or Remifentanil and/or Rocuronium
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Geneva University Hospitals
Geneva, 1211
Gergely Albu, MD, PhD, 0041795532052, gergely.albu@hcuge.ch
About this study
Official title: Comparison of Flow-Controlled Ventilation With EVONE Tritube and High Frequency Jet Ventilation in Patients Undergoing Laryngotracheal Surgery
Laryngotracheal surgery often requires a small diameter endotracheal tube to oxygenate patients under general anesthesia. Oxygenation is often only possible with high-frequency jet ventilators due to the use of small diameter and high resistance airway cannulas.
Flow controlled ventilation is a new ventilation modality capable for ventilation through a small diameter endotracheal tube (Tritube) with an active expiratory phase and the possibility of controlled carbon dioxide elimination during mechanical ventilation.
The aim of the present trial is to characterize perioperative changes in lung volume, ventilation inhomogeneity and respiratory mechanics in patients undergo upper airway surgery under general anesthesia with either flow controlled or high-frequency jet ventilation.
Read the detailed description
This study is a randomized, controlled, assessor blind, monocentric study.
A new ventilation mode, called Flow Controlled Ventilation (FCV), has been suggested to minimize the amount of dissipated energy in the lungs and potentially could be protective during mechanical ventilation. FCV is unique in creating a stable gas flow into and also out of the patient's lungs to generate inspiration and expiration respectively. The FCV ventilation mode by its design allows the use of an ultrathin endotracheal tube with an inflatable cuff to secure the airways for ventilation. Therefore FCV offers several new surgical options for the treatment during laryngeal and tracheal surgery where the standard approach is usually the use of high-frequency jet ventilation (HFJV). The limitations of HFJV are however the lack of airway protection, limited monitoring of the respiratory variables and potential carbon dioxide (CO2) accumulation.
Participants for this study will be recruited at the University Hospitals of Geneva, scheduled for laryngotracheal surgery under general anesthesia. A total of 50 patients will be enrolled and randomly assigned into 2 groups: Group FCV (Flow controlled ventilation) and Group HFJV (high-frequency jet ventilation).
Measurements of functional residual capacity (FRC) and lung clearance index (LCI) will be performed in patients with a nitrogen multiple breath washout method, before and approximately 1 hour after surgery. Similarly, respiratory system resistance (R) and respiratory reactance (X) will be measured at the same time by using the Forced Oscillation Technique.
Relevance: There are no studies that addressed the value of flow controlled ventilation in terms of lung function parameters (FRC and LCI) and lung mechanics (R, X) in comparison to high-frequency jet ventilation in patients undergoing upper airway surgery.
- Conditions
- Ventilation, Lung Function, Anesthesia, General
- Being tested
- General anesthesia for laryngotracheal surgery, Mechanical ventilation by FCV, Mechanical ventilation by HFJV
- Keywords
- Flow-controlled ventilation, High frequency jet ventilation, Lung protection, Laryngotracheal surgery
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General anesthesia for laryngotracheal surgeryOther
Patients undergoing general anesthesia and mechanical ventilation.
Mechanical ventilation by FCVOther
Mechanical ventilation is assured by Flow-controlled ventilation mode.
Mechanical ventilation by HFJVOther
Mechanical ventilation is assured by High frequency jet ventilation mode.
| Study group | Role | What they receive |
|---|---|---|
| Flow Controlled Ventilation Group | Experimental | Ventilation by Flow Controlled Ventilation mode Patient is scheduled for elective laryngotracheal surgery under general anesthesia. The ventilation mode for this group is Flow Controlled Ventilation mode. Receives: Other: General anesthesia for laryngotracheal surgery; Other: Mechanical ventilation by FCV |
| High Frequency Jet ventilation Group | Active comparator | Ventilation by High Frequency Jet ventilation mode Patient is scheduled for elective laryngotracheal surgery under general anesthesia. The ventilation mode for this group is High Frequency Jet ventilation mode. Receives: Other: General anesthesia for laryngotracheal surgery; Other: Mechanical ventilation by HFJV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alterations in the functional residual capacity (FRC)
FRC measured by the nitrogen multiple breath washout technique that will be applied before and after general anesthesia
Measured: Right before general anesthesia and approximately 1 hour after general anesthesia or before discharge from post anesthesia care unit
Secondary outcomes (3)
Alterations in the Lung clearance index (LCI)
LCI measured by the nitrogen multiple breath washout technique that will be applied before and after general anesthesia
Measured: Right before general anesthesia and approximately 1 hour after general anesthesia or before discharge from post anesthesia care unit
Alterations in the respiratory resistance assessed by the forced oscillation technique (FOT)
Respiratory mechanics will be measured by the forced oscillation technique (FOT) to evaluate respiratory resistance (R).
Measured: Right before general anesthesia and approximately 1 hour after general anesthesia or before discharge from post anesthesia care unit
Alterations in the respiratory reactance assessed by the forced oscillation technique (FOT)
Respiratory mechanics will be measured by the forced oscillation technique (FOT) to evaluate respiratory reactance (X).
Measured: Right before general anesthesia and approximately 1 hour after general anesthesia or before discharge from post anesthesia care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start5 Sep 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for VentilationStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Gergely Albu, University Hospital, Geneva
- Investigators
- Gergely Albu, MD, PhD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06063798
- Sponsor's protocol ID
- BASEC2022-D0078
- Other IDs
- SNCTP000005183
- Acronym
- Flowjet
- Status last verified
- Sep 2023
- First submitted
- 18 Sep 2023
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Neder JA, Andreoni S, Castelo-Filho A, Nery LE. Reference values for lung function tests. I. Static volumes. Braz J Med Biol Res. 1999 Jun;32(6):703-17. doi: 10.1590/s0100-879x1999000600006.
PubMed 10412549Bourgain JL, Chollet M, Fischler M, Gueret G, Mayne A; membres du conseil du club en anesthesie en ORL. [Guide for the use of jet-ventilation during ENT and oral surgery]. Ann Fr Anesth Reanim. 2010 Oct;29(10):720-7. doi: 10.1016/j.annfar.2010.06.020. Epub 2010 Sep 15. French.
PubMed 20833503Bacher A, Pichler K, Aloy A. Supraglottic combined frequency jet ventilation versus subglottic monofrequent jet ventilation in patients undergoing microlaryngeal surgery. Anesth Analg. 2000 Feb;90(2):460-5. doi: 10.1097/00000539-200002000-00041.
PubMed 10648340Barnes T, van Asseldonk D, Enk D. Minimisation of dissipated energy in the airways during mechanical ventilation by using constant inspiratory and expiratory flows - Flow-controlled ventilation (FCV). Med Hypotheses. 2018 Dec;121:167-176. doi: 10.1016/j.mehy.2018.09.038. Epub 2018 Sep 24.
PubMed 30396474Tonetti T, Vasques F, Rapetti F, Maiolo G, Collino F, Romitti F, Camporota L, Cressoni M, Cadringher P, Quintel M, Gattinoni L. Driving pressure and mechanical power: new targets for VILI prevention. Ann Transl Med. 2017 Jul;5(14):286. doi: 10.21037/atm.2017.07.08.
PubMed 28828361Cressoni M, Gotti M, Chiurazzi C, Massari D, Algieri I, Amini M, Cammaroto A, Brioni M, Montaruli C, Nikolla K, Guanziroli M, Dondossola D, Gatti S, Valerio V, Vergani GL, Pugni P, Cadringher P, Gagliano N, Gattinoni L. Mechanical Power and Development of Ventilator-induced Lung Injury. Anesthesiology. 2016 May;124(5):1100-8. doi: 10.1097/ALN.0000000000001056.
PubMed 26872367Schmidt J, Wenzel C, Mahn M, Spassov S, Cristina Schmitz H, Borgmann S, Lin Z, Haberstroh J, Meckel S, Eiden S, Wirth S, Buerkle H, Schumann S. Improved lung recruitment and oxygenation during mandatory ventilation with a new expiratory ventilation assistance device: A controlled interventional trial in healthy pigs. Eur J Anaesthesiol. 2018 Oct;35(10):736-744. doi: 10.1097/EJA.0000000000000819.
PubMed 29734208Meulemans J, Jans A, Vermeulen K, Vandommele J, Delaere P, Vander Poorten V. Evone(R) Flow-Controlled Ventilation During Upper Airway Surgery: A Clinical Feasibility Study and Safety Assessment. Front Surg. 2020 Feb 28;7:6. doi: 10.3389/fsurg.2020.00006. eCollection 2020.
PubMed 32185179
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Flow-Controlled Ventilation With EVONE Tritube and High Frequency Jet Ventilation in Patients Undergoing Laryngotracheal Surgery
- ClinicalTrials.gov ID
- NCT06063798
- Acronym / sponsor ID
- Flowjet / BASEC2022-D0078
- Conditions
- Ventilation, Lung Function, Anesthesia, General
- Keywords
- Flow-controlled ventilation, High frequency jet ventilation, Lung protection, Laryngotracheal surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 3 Oct 2023 (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.
Laryngotracheal surgery often requires a small diameter endotracheal tube to oxygenate patients under general anesthesia. Oxygenation is often only possible with high-frequency jet ventilators due to the use of small diameter and high resistance airway cannulas.
Flow controlled ventilation is a new ventilation modality capable for ventilation through a small diameter endotracheal tube (Tritube) with an active expiratory phase and the possibility of controlled carbon dioxide elimination during mechanical ventilation.
The aim of the present trial is to characterize perioperative changes in lung volume, ventilation inhomogeneity and respiratory mechanics in patients undergo upper airway surgery under general anesthesia with either flow controlled or high-frequency jet ventilation.
Detailed description
This study is a randomized, controlled, assessor blind, monocentric study.
A new ventilation mode, called Flow Controlled Ventilation (FCV), has been suggested to minimize the amount of dissipated energy in the lungs and potentially could be protective during mechanical ventilation. FCV is unique in creating a stable gas flow into and also out of the patient's lungs to generate inspiration and expiration respectively. The FCV ventilation mode by its design allows the use of an ultrathin endotracheal tube with an inflatable cuff to secure the airways for ventilation. Therefore FCV offers several new surgical options for the treatment during laryngeal and tracheal surgery where the standard approach is usually the use of high-frequency jet ventilation (HFJV). The limitations of HFJV are however the lack of airway protection, limited monitoring of the respiratory variables and potential carbon dioxide (CO2) accumulation.
Participants for this study will be recruited at the University Hospitals of Geneva, scheduled for laryngotracheal surgery under general anesthesia. A total of 50 patients will be enrolled and randomly assigned into 2 groups: Group FCV (Flow controlled ventilation) and Group HFJV (high-frequency jet ventilation).
Measurements of functional residual capacity (FRC) and lung clearance index (LCI) will be performed in patients with a nitrogen multiple breath washout method, before and approximately 1 hour after surgery. Similarly, respiratory system resistance (R) and respiratory reactance (X) will be measured at the same time by using the Forced Oscillation Technique.
Relevance: There are no studies that addressed the value of flow controlled ventilation in terms of lung function parameters (FRC and LCI) and lung mechanics (R, X) in comparison to high-frequency jet ventilation in patients undergoing upper airway surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flow Controlled Ventilation Group | Experimental | Other: General anesthesia for laryngotracheal surgery, Other: Mechanical ventilation by FCVVentilation by Flow Controlled Ventilation mode Patient is scheduled for elective laryngotracheal surgery under general anesthesia. The ventilation mode for this group is Flow Controlled Ventilation mode. |
| High Frequency Jet ventilation Group | Active comparator | Other: General anesthesia for laryngotracheal surgery, Other: Mechanical ventilation by HFJVVentilation by High Frequency Jet ventilation mode Patient is scheduled for elective laryngotracheal surgery under general anesthesia. The ventilation mode for this group is High Frequency Jet ventilation mode. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed Consent signed by the subject
- General anesthesia for laryngotracheal surgery
- Adult patients, female and male, over 18 years of age
- Elective surgery
Key exclusion criteria (8 listed)
- Documented severe heart conditions (New York Heart Association Class 4, severe pulmonary hypertension)
- Documented severe respiratory disease (uncontrolled asthma, severe pulmonary fibrosis, chronic obstructive pulmonary disease GOLD 4)
- Documented severe Neurological diseases (Acute ischemic and hemorrhagic stroke within the preceding 3 months, uncontrolled seizures)
- Surgery that requires tracheotomy
- Obesity (Body Mass Index ≥ 30 kg/m2)
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 |
|---|---|---|
| General anesthesia for laryngotracheal surgeryPatients undergoing general anesthesia and mechanical ventilation. | Other | Flow Controlled Ventilation Group, High Frequency Jet ventilation Group |
| Mechanical ventilation by FCVMechanical ventilation is assured by Flow-controlled ventilation mode. | Other | Flow Controlled Ventilation Group |
| Mechanical ventilation by HFJVMechanical ventilation is assured by High frequency jet ventilation mode. | Other | High Frequency Jet ventilation Group |
Primary outcome
Alterations in the functional residual capacity (FRC)
Time frame: Right before general anesthesia and approximately 1 hour after general anesthesia or before discharge from post anesthesia care unit
FRC measured by the nitrogen multiple breath washout technique that will be applied before and after general anesthesia
3 secondary outcomes
Alterations in the Lung clearance index (LCI)
Time frame: Right before general anesthesia and approximately 1 hour after general anesthesia or before discharge from post anesthesia care unit
Alterations in the respiratory resistance assessed by the forced oscillation technique (FOT)
Time frame: Right before general anesthesia and approximately 1 hour after general anesthesia or before discharge from post anesthesia care unit
Alterations in the respiratory reactance assessed by the forced oscillation technique (FOT)
Time frame: Right before general anesthesia and approximately 1 hour after general anesthesia or before discharge from post anesthesia care unit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Background: PubMed 10412549Neder JA, Andreoni S, Castelo-Filho A, Nery LE. Reference values for lung function tests. I. Static volumes. Braz J Med Biol Res. 1999 Jun;32(6):703-17. doi: 10.1590/s0100-879x1999000600006.
- Background: PubMed 20833503Bourgain JL, Chollet M, Fischler M, Gueret G, Mayne A; membres du conseil du club en anesthesie en ORL. [Guide for the use of jet-ventilation during ENT and oral surgery]. Ann Fr Anesth Reanim. 2010 Oct;29(10):720-7. doi: 10.1016/j.annfar.2010.06.020. Epub 2010 Sep 15. French.
- Background: PubMed 10648340Bacher A, Pichler K, Aloy A. Supraglottic combined frequency jet ventilation versus subglottic monofrequent jet ventilation in patients undergoing microlaryngeal surgery. Anesth Analg. 2000 Feb;90(2):460-5. doi: 10.1097/00000539-200002000-00041.
- Background: PubMed 30396474Barnes T, van Asseldonk D, Enk D. Minimisation of dissipated energy in the airways during mechanical ventilation by using constant inspiratory and expiratory flows - Flow-controlled ventilation (FCV). Med Hypotheses. 2018 Dec;121:167-176. doi: 10.1016/j.mehy.2018.09.038. Epub 2018 Sep 24.
- Background: PubMed 28828361Tonetti T, Vasques F, Rapetti F, Maiolo G, Collino F, Romitti F, Camporota L, Cressoni M, Cadringher P, Quintel M, Gattinoni L. Driving pressure and mechanical power: new targets for VILI prevention. Ann Transl Med. 2017 Jul;5(14):286. doi: 10.21037/atm.2017.07.08.
- Background: PubMed 26872367Cressoni M, Gotti M, Chiurazzi C, Massari D, Algieri I, Amini M, Cammaroto A, Brioni M, Montaruli C, Nikolla K, Guanziroli M, Dondossola D, Gatti S, Valerio V, Vergani GL, Pugni P, Cadringher P, Gagliano N, Gattinoni L. Mechanical Power and Development of Ventilator-induced Lung Injury. Anesthesiology. 2016 May;124(5):1100-8. doi: 10.1097/ALN.0000000000001056.
- Background: PubMed 29734208Schmidt J, Wenzel C, Mahn M, Spassov S, Cristina Schmitz H, Borgmann S, Lin Z, Haberstroh J, Meckel S, Eiden S, Wirth S, Buerkle H, Schumann S. Improved lung recruitment and oxygenation during mandatory ventilation with a new expiratory ventilation assistance device: A controlled interventional trial in healthy pigs. Eur J Anaesthesiol. 2018 Oct;35(10):736-744. doi: 10.1097/EJA.0000000000000819.
- Background: PubMed 32185179Meulemans J, Jans A, Vermeulen K, Vandommele J, Delaere P, Vander Poorten V. Evone(R) Flow-Controlled Ventilation During Upper Airway Surgery: A Clinical Feasibility Study and Safety Assessment. Front Surg. 2020 Feb 28;7:6. doi: 10.3389/fsurg.2020.00006. eCollection 2020.
- Individual participant dataSharing planned: No
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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.
Gergely Albu, MD, PhD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General anesthesia for laryngotracheal surgery, Mechanical ventilation by FCV and Mechanical ventilation by HFJV in people with Ventilation and Lung Function, run by University Hospital, Geneva at 1 site in Switzerland.
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 8 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 3 Oct 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 Switzerland. 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 Gergely Albu, MD, PhD (0041795532052, gergely.albu@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alterations in the functional residual capacity (FRC) (time frame: Right before general anesthesia and approximately 1 hour after general anesthesia or before discharge from post anesthesia care unit). 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 NCT06063798, which also lists 8 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 3 Oct 2023.