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

September 25, 2023 updated by: Dr. Gergely Albu, University Hospital, Geneva

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1211
        • Recruiting
        • Geneva University Hospitals
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Flow Controlled Ventilation Group
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
Patients undergoing general anesthesia and mechanical ventilation.
Other: Mechanical ventilation by FCV
Mechanical ventilation is assured by Flow-controlled ventilation mode.
Active Comparator: High Frequency Jet ventilation Group
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
Patients undergoing general anesthesia and mechanical ventilation.
Other: Mechanical ventilation by HFJV
Mechanical ventilation is assured by High frequency jet ventilation mode.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Right before general anesthesia and approximately 1 hour after general anesthesia or before discharge from post anesthesia care unit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
Time Frame: Right before general anesthesia and approximately 1 hour after general anesthesia or before discharge from post anesthesia care unit
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)
Time Frame: Right before general anesthesia and approximately 1 hour after general anesthesia or before discharge from post anesthesia care unit
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in mean blood pressure
Time Frame: Intraoperative period with specific time points: before anesthesia induction, at the beginning of the surgery, at the end of surgery, right after extubation
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
Time Frame: Intraoperative period with specific time points: before anesthesia induction, at the beginning of the surgery, at the end of surgery, right after extubation
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
Time Frame: Intraoperative period with specific time points: before anesthesia induction, at the beginning of the surgery, at the end of surgery, right after extubation
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
Time Frame: Intraoperative period with specific time points: before anesthesia induction, at the beginning of the surgery, at the end of surgery, right after extubation
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Investigators

  • Principal Investigator: Gergely Albu, MD, PhD, University Hospital, Geneva

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

September 18, 2023

First Submitted That Met QC Criteria

September 25, 2023

First Posted (Actual)

October 3, 2023

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

September 25, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BASEC2022-D0078
  • SNCTP000005183 (Registry Identifier: KOFAM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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