The objective is to investigate if there is a flow-dependent effect of HFNC on ventilation during an EBUS procedure under procedural sedation in patients with COPD gold class 3-4.
ID
Source
Brief title
Condition
- Other condition
- Bronchial disorders (excl neoplasms)
- Respiratory tract therapeutic procedures
Synonym
Health condition
Sedatie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The CO2-washout will be measured by:
- insp CO2
- exp CO2
- CO2-waveform analysis
Secondary outcome
Secundary outcomes will be:
- a difference in CO2-washout in different levels of the trachea (carina en
left main bronchus).
- a flow-dependency
There will be controlled for capillary CO2.
Background summary
HFNC is commonly used during sedation to avoid deoxygenation. However, HFNC
also reduces dead space, which facilitates ventilation, as Intensive
Care-related research points out.
It is unclear if HNFC also facilitates ventilation when the airway is partially
obstructed by a bronchoscope. It is required to investigate this, in order to
avoid false expectations of the use of HFNC during an EBUS-procedure.
Study objective
The objective is to investigate if there is a flow-dependent effect of HFNC on
ventilation during an EBUS procedure under procedural sedation in patients with
COPD gold class 3-4.
Study design
A randomized controlled trial
Intervention
The patients will start with 3L O2/min through a nasal cannula. This will be
replaced by HFNC after 10 minutes, which will be set with a flow of 30 or 70
L/min, depending on the randomisation. After 15 minutes, the flow of the HFNC
will be set at the other flow (30 of 70 L/min) during 15 minutes.
Study burden and risks
The additional burden for a patient consists of 4 times a capillary bloodsample
during sedation. All other measurements take place during the EBUS, with
equipment already being used in the patient.
There is no additional risk, since the intervention (HFNC) is already being
used in regular Dutch practice.
korenschoofstraat 173
Utrecht 3513 DE
NL
korenschoofstraat 173
Utrecht 3513 DE
NL
Listed location countries
Age
Inclusion criteria
Adult patients scheduled for EBUS with sedation
COPD gold class 3-4
Exclusion criteria
- Neuromusculaire diseases, such as Guillan Barre, MS, ALS
- allergy to propofol or esketamine
- Systolic pulmonary pressure > 60 mmHg
- Pregnancy
- Children (age <18)
- Upper airway obstruction, such as stenosis or tumour
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL80926.091.22 |