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

NCT06063798 | Unknown DMC

• 2 other identifiers: BASEC2022-D0078SNCTP000005183
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ventilation; Lung Function; Anesthesia, General

Keywords

Flow-controlled ventilation; High frequency jet ventilation; Lung protection; Laryngotracheal surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Alterations in the Lung clearance index (LCI)

  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)

  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)

  Right before general anesthesia and approximately 1 hour after general anesthesia or before discharge from post anesthesia care unit

Other Outcomes (4)

• Changes in mean blood pressure

  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

  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

  Intraoperative period with specific time points: before anesthesia induction, at the beginning of the surgery, at the end of surgery, right after extubation

Study Arms (2)

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.

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.

Other: General anesthesia for laryngotracheal surgery; Other: Mechanical ventilation by HFJV

Interventions

General anesthesia for laryngotracheal surgery OTHER

Patients undergoing general anesthesia and mechanical ventilation.

Flow Controlled Ventilation Group; High Frequency Jet ventilation Group

Mechanical ventilation by FCV OTHER

Mechanical ventilation is assured by Flow-controlled ventilation mode.

Flow Controlled Ventilation Group

Mechanical ventilation by HFJV OTHER

Mechanical ventilation is assured by High frequency jet ventilation mode.

High Frequency Jet ventilation Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed Consent signed by the subject
• General anesthesia for laryngotracheal surgery
• Adult patients, female and male, over 18 years of age
• Elective surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Geneva University Hospitals

Geneva, 1211, Switzerland

RECRUITING

Related Publications (8)

• 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.

  PMID: 10412549 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.

  PMID: 20833503 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.

  PMID: 10648340 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.

  PMID: 30396474 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.

  PMID: 28828361 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.

  PMID: 26872367 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.

  PMID: 29734208 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.

  PMID: 32185179 BACKGROUND

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Gergely Albu, MD, PhD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gergely Albu, MD, PhD

CONTACT

0041795532052; gergely.albu@hcuge.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: October 3, 2023
• Study Start: September 5, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 3, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)