- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06285994
Complications of High Frequency Jet Ventilation
Complications of High Frequency Jet Ventilation During Bronchoscopy - a Retrospective Cohort Study
High frequency jet ventilation (HFJV) has been introduced in 1967 as technique allowing ventilation with simultaneous access to the airway for bronchoscopy. Continuous improvement in the technique has led to a large use during interventional bronchoscopy, especially in large centers. However, complications occuring during the use of HFJV are poorly known. In this retrospective cohort study, the charts of all patients who had a bronchoscopy with the use of HFJV between 2019 and 2023 in our hospital will be analyzed. Primary outcome will the description of all complications during HFJV. Complications are defined as:
- Hypoxia: SpO2 < 90% for 1 min
- Severe hypoxia: SpO2 < 85% for 1 min
- Hemodynamic instability, defined as Arterial pressure < 90/60
- Cardiac arrhythmia
- Laryngospasm or bronchospasm
- Barotrauma or volutrauma
- Need for ICU admission
A model predicting the risk for developing any complication will be developped using 2 mathematical methods:
- a multivariate analysis
- a data mining approach
For both approaches, the following variables will be included in the model:
- Age
- Gender
- Weight
- Height
- BMI
- Smoking
- Alcohol consumption
- Consumption of Other drugs
- ASA class
- Obstructive pulmonary disease
- Restrictive lung disease
- COPD status (1, 2, 3, 4)
- Interstitial lung disease
Lung tumor
- Trachea location
- Carina location
- Bronchial location
- Pulmonary or tracheal stenosis
- Presence of stridor
- Severe stenosis (< 6 mm)
- Baseline SpO2 (pre-intervention)
- Pre-intervention oxygen requirement Procedure
- Duration (min)
- Stent placement
- Dilation
- Laser treatment
- Length of hospital stay Lung function tests
- FEV1 (forced expiratory volume)
- VC (Vital Capacity)
- FEV1/VC (Tiffeneau ratio)
- CPT (total lung capacity)
- DLCO (carbon monoxide diffusion)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Brussels, Belgium, 1070
- Hopital Universitaire de Bruxelles - Hopital Erasme
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients who underwent a bronchoscopy with the use of high frequency jet ventilation between January 1st, 2019 and December 31st, 2023 at Erasme University Hospital, Brussels
Exclusion Criteria:
- Incomplete medical chart
- Patient who expressed their opposition to the use of their medical data
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
HFJV
All patients who underwent bronchoscopy with the use of high frequency jet ventilation between January 1st 2019 and december 31st 2023.
|
Use of high frequency jet ventilation during bronchoscopy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Occurence of complications
Time Frame: 6 hours
|
The occurence (%) of complications of HFJV will be analyzed. Definition of complications is one or more of the following events:
Complications will be reported as overall complications (%) defined as the occurence of one or more of the listed events. Frequency of single events will be reported separately (%). Descriptive statistics ( %, mean, standard deviation, median, interquartile range) will be used as appropriate. |
6 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prediction model of complications
Time Frame: 6 hours
|
A model predicting the risk for developing any complication will be developped using 2 mathematical methods:
|
6 hours
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Aravena C, Mehta AC, Almeida FA, Lamb C, Maldonado F, Gildea TR. Innovation in rigid bronchoscopy-past, present, and future. J Thorac Dis. 2023 May 30;15(5):2836-2847. doi: 10.21037/jtd-22-779. Epub 2023 Apr 25.
- Putz L, Mayne A, Dincq AS. Jet Ventilation during Rigid Bronchoscopy in Adults: A Focused Review. Biomed Res Int. 2016;2016:4234861. doi: 10.1155/2016/4234861. Epub 2016 Oct 26.
- Poling HE, Wolfson B, Siker ES. A technique of ventilation during laryngoscopy and bronchoscopy. Br J Anaesth. 1975 Mar;47(3):382-4. doi: 10.1093/bja/47.3.382.
- Klain M, Smith RB. High frequency percutaneous transtracheal jet ventilation. Crit Care Med. 1977 Nov-Dec;5(6):280-7. doi: 10.1097/00003246-197711000-00007. No abstract available.
- Hautmann H, Gamarra F, Henke M, Diehm S, Huber RM. High frequency jet ventilation in interventional fiberoptic bronchoscopy. Anesth Analg. 2000 Jun;90(6):1436-40. doi: 10.1097/00000539-200006000-00034.
- Ost DE, Ernst A, Grosu HB, Lei X, Diaz-Mendoza J, Slade M, Gildea TR, Machuzak M, Jimenez CA, Toth J, Kovitz KL, Ray C, Greenhill S, Casal RF, Almeida FA, Wahidi M, Eapen GA, Yarmus LB, Morice RC, Benzaquen S, Tremblay A, Simoff M; AQuIRE Bronchoscopy Registry. Complications Following Therapeutic Bronchoscopy for Malignant Central Airway Obstruction: Results of the AQuIRE Registry. Chest. 2015 Aug;148(2):450-471. doi: 10.1378/chest.14-1530.
- Goudra BG, Singh PM, Borle A, Farid N, Harris K. Anesthesia for Advanced Bronchoscopic Procedures: State-of-the-Art Review. Lung. 2015 Aug;193(4):453-65. doi: 10.1007/s00408-015-9733-7. Epub 2015 Apr 29.
- Fernandez-Bustamante A, Ibanez V, Alfaro JJ, de Miguel E, German MJ, Mayo A, Jimeno A, Perez-Cerda F, Escribano PM. High-frequency jet ventilation in interventional bronchoscopy: factors with predictive value on high-frequency jet ventilation complications. J Clin Anesth. 2006 Aug;18(5):349-56. doi: 10.1016/j.jclinane.2005.12.011.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SRB2024016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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