Complications of High Frequency Jet Ventilation

Bronchoscopy Clinical Trial

Official title:

Complications of High Frequency Jet Ventilation During Bronchoscopy - a Retrospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06285994
• Other study ID #: SRB2024016
• Status: Recruiting
• Start date: April 20, 2024
• Est. completion date: October 31, 2024

Study information

• Verified date: April 2024
• Source: Erasme University Hospital
• Contact: Denis Schmartz, MD
• Phone: +3225553919
• Email: denis.schmartz[@]hubruxelles.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: October 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bronchoscopy
• High-Frequency Jet Ventilation

Intervention

Procedure:
• High frequency jet ventilation
Use of high frequency jet ventilation during bronchoscopy

Locations

Country	Name	City	State
Belgium	Hôpital Universitaire de Bruxelles - Hôpital erasme	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

References & Publications (8)

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. — View Citation

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. Erratum In: J Clin Anesth. 2006 Sep;18(6):481. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurence of complications	The occurence (%) of complications of HFJV will be analyzed. Definition of complications is one or more of the following events: 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 (%); 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	Prediction model of complications	A model predicting the risk for developing any complication will be developped using 2 mathematical methods: a multivariate analysis; a data mining approach	6 hours