Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-27 @ 6:23 AM
Study NCT ID:
NCT06285994
Status:
COMPLETED
Last Update Posted:
2025-05-21
First Post:
2024-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Complications of High Frequency Jet Ventilation
Sponsor:
Erasme University Hospital
Organization:
Study Overview
Official Title:
Complications of High Frequency Jet Ventilation During Bronchoscopy - a Retrospective Cohort Study
Status:
COMPLETED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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)
* 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)
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: