Respiratory Effects of Flow-Controlled Ventilation and Jet Ventilation in Patients Undergoing Laryngotracheal Surgery

Anesthesia, General Clinical Trial

— Flowjet  

Official title:

Comparison of Flow-Controlled Ventilation With EVONE Tritube and High Frequency Jet Ventilation in Patients Undergoing Laryngotracheal Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06063798
• Other study ID #: BASEC2022-D0078
• Secondary ID: SNCTP000005183
• Status: Recruiting
• Phase: N/A
• Start date: September 5, 2023
• Est. completion date: December 2025

Study information

• Verified date: September 2023
• Source: University Hospital, Geneva
• Contact: Gergely Albu, MD, PhD
• Phone: 0041795532052
• Email: gergely.albu[@]hcuge.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Informed Consent signed by the subject

• General anesthesia for laryngotracheal surgery

• Adult patients, female and male, over 18 years of age

• Elective surgery

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Anesthesia, General
• Lung Function
• Ventilation

Intervention

Other:
• General anesthesia for laryngotracheal surgery
Patients undergoing general anesthesia and mechanical ventilation.
• Mechanical ventilation by FCV
Mechanical ventilation is assured by Flow-controlled ventilation mode.
• Mechanical ventilation by HFJV
Mechanical ventilation is assured by High frequency jet ventilation mode.

Locations

Country	Name	City	State
Switzerland	Geneva University Hospitals	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Changes in heart rate	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
Other	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
Other	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
Primary	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
Secondary	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
Secondary	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).	Right before general anesthesia and approximately 1 hour after general anesthesia or before discharge from post anesthesia care unit
Secondary	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