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| ID | Type | Description | Link |
|---|---|---|---|
| SNCTP000005183 | Registry Identifier | KOFAM |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| General anesthesia for laryngotracheal surgery | Other | Patients undergoing general anesthesia and mechanical ventilation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Right before general anesthesia and approximately 1 hour after general anesthesia or before discharge from post anesthesia care unit |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in mean blood pressure | mean blood pressure (mmHg) | Intraoperative period with specific time points: before anesthesia induction, at the beginning of the surgery, at the end of surgery, right after extubation |
| Changes in heart rate |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gergely Albu, MD, PhD | Contact | 0041795532052 | gergely.albu@hcuge.ch |
| Name | Affiliation | Role |
|---|---|---|
| Gergely Albu, MD, PhD | University Hospital, Geneva | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geneva University Hospitals | Recruiting | Geneva | 1211 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10412549 | Background | 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. | |
| 20833503 | Background | Bourgain 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. |
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| Mechanical ventilation by FCV | Other | Mechanical ventilation is assured by Flow-controlled ventilation mode. |
|
| Mechanical ventilation by HFJV | Other | Mechanical ventilation is assured by High frequency jet ventilation mode. |
|
Respiratory mechanics will be measured by the forced oscillation technique (FOT) to evaluate respiratory resistance (R). |
| 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). | Right before general anesthesia and approximately 1 hour after general anesthesia or before discharge from post anesthesia care unit |
heart rate (beat per minute)
| Intraoperative period with specific time points: before anesthesia induction, at the beginning of the surgery, at the end of surgery, right after extubation |
| Changes in oxygen saturation | Oxygen saturation will be measured by pulse oximetry (%) | Intraoperative period with specific time points: before anesthesia induction, at the beginning of the surgery, at the end of surgery, right after extubation |
| Changes in transcutaneous carbon dioxide | Transcutaneous carbon dioxide will be measured | Intraoperative period with specific time points: before anesthesia induction, at the beginning of the surgery, at the end of surgery, right after extubation |
| 10648340 | Background | Bacher 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. |
| 30396474 | Background | Barnes 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. |
| 28828361 | Background | Tonetti 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. |
| 26872367 | Background | Cressoni 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. |
| 29734208 | Background | Schmidt 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. |
| 32185179 | Background | Meulemans 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. |
| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000768 | Anesthesia, General |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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