Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06285994
Status:
RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-02-12
Brief Title:
Complications of High Frequency Jet Ventilation
Sponsor:
Erasme University Hospital
Organization:
Erasme University Hospital
Study Overview
Official Title:
Complications of High Frequency Jet Ventilation During Bronchoscopy - a Retrospective Cohort Study
Status:
RECRUITING
Status Verified Date:
2024-04
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 9060
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
FEV1VC 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 9060
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
FEV1VC Tiffeneau ratio
CPT total lung capacity
DLCO carbon monoxide diffusion
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None