Chartis Collateral Ventilation Measurement: Conscious Sedation Versus General Anesthesia

NCT03205826 | Completed

• 1 other identifier: CHARTIS sedation
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: The Chartis® ( Pulmonx, CA, USA) measurement system is a tool to assess interlobar collateral ventilation during bronchoscopy. Assessing collateral ventilation is important when you intend to treat a patient with endobronchial valves. Chartis measurement of collateral ventilation can be performed under both conscious sedation as well as general anesthesia. There is no consensus on what is the preferred method of anesthesia for Chartis measurements in the literature. Objective: In this project we want to investigate whether there is a difference in Chartis measurement outcomes between these two methods of anesthesia: conscious sedation and general anesthesia. Study design: This study will be a single center observational study Study population: The study population exists of patients with severe emphysema who undergo collateral ventilation assessment before bronchoscopic lung volume reduction treatment with one-way endobronchial valves. Intervention: All patients will undergo two subsequent Chartis measurements. The first measurement will be performed with the patient undergoing conscious sedation and the second measurement with the patient under general anesthesia. Main study parameters/endpoints: Our primary outcome measure is the failure rate of the Chartis collateral ventilation measurement under general anesthesia versus conscious sedation.

Conditions

Emphysema or COPD

Keywords

Emphysema; Bronchoscopic intervention; CHARTIS measurement

Outcome Measures

Primary Outcomes (1)

• Failure rate

  The failure rate of the Chartis collateral ventilation measurement under general anesthesia versus conscious sedation.

  Baseline

Secondary Outcomes (4)

• Chartis measurement duration

  Baseline

• Physician feasibility

  Baseline

• Influence severity on outcome

  Baseline

• Influence collateral ventilation status on outcome

  Baseline

Study Arms (1)

Type of sedation used

OTHER

All patients will undergo two subsequent Chartis measurements. The first measurement will be performed with the patient undergoing conscious sedation and the second measurement with the patient under general anesthesia.

Other: Type of sedation used

Interventions

Type of sedation used OTHER

All patients will undergo two subsequent Chartis measurements. The first measurement will be performed with the patient undergoing conscious sedation and the second measurement with the patient under general anesthesia.

Type of sedation used

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is scheduled for a bronchoscopic lung volume treatment using one-way valves
• Patient has provided signed informed consent.

You may not qualify if:

• For safety reasons patients that meet the following criteria will not be included in this study:
• FEV1 \<20%
• RV/TLC\>70%
• pCO2 \>6.5
• RVSP\>40mmHg
• MWT\<200m
• Known intolerance to Lidocaine
• Any other medical reason/condition that warrants a short procedure (physician judgement )

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, Netherlands

Location

Related Publications (1)

• Welling JBA, Klooster K, Hartman JE, Kerstjens HAM, Franz I, Struys MMRF, Absalom AR, Slebos DJ, Barends CRM. Collateral Ventilation Measurement Using Chartis: Procedural Sedation vs General Anesthesia. Chest. 2019 Nov;156(5):984-990. doi: 10.1016/j.chest.2019.07.025. Epub 2019 Aug 15.

  PMID: 31421111 DERIVED

MeSH Terms

Conditions

Emphysema; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes

Study Officials

• Dirk-Jan Slebos, MD PhD

  d.j.slebos@umcg.nl

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: July 2, 2017
• Study Start: March 1, 2018
• Primary Completion: January 22, 2019
• Study Completion: January 22, 2019
• Last Updated: April 17, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)