Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05875662 |
Other study ID # |
PekingUPH-2023z038 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
May 5, 2023 |
Est. completion date |
March 31, 2024 |
Study information
Verified date |
April 2024 |
Source |
Peking University People's Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
Background: Fiber bronchoscopy is a routine operation in intensive care unit (ICU), but it
may cause local collapse of the lung. Recruitment maneuver (RM) after fiber bronchoscopy may
have the potential to restore functional residual air volume and increase lung volume.
However, there is still a lack of quantitative indicators to evaluate the effect of
recruitment maneuver. With electrical impedance tomography (EIT), we can monitor lung
ventilation in real time to understand the situation of lung ventilation.
Objective: To evaluate whether recruitment maneuver after fiber bronchoscopy can improve lung
volume and improve lung ventilation, and which people are most likely to benefit from it, by
monitoring the end expiratory pulmonary impedance of critically ill patients undergoing
bedside fiber bronchoscopy to monitor the lung ventilation before and after the operation and
before and after recruitment maneuver.
Study Design: A prospective observational study was conducted to monitor the end expiratory
lung impedance (EELI), tidal impedance variable (TIV), global inhomogeneity (GI) index and
Center of Ventilation (CoV) before and after bronchoscopy and recruitment maneuver, and then
to understand the changes of lung volume and ventilation.
Description:
At present, people pay more and more attention to the atelectasis caused by the sputum
suction operation of fiberoptic bronchoscope. A recent observational study confirmed that
more than 80% of patients will have atelectasis in at least one lung segment after the
completion of the bronchoscope operation using the imaging method of cluster computed
tomography (CT). The production of atelectasis will affect the patient's subsequent
ventilation function, causing hypoxemia. Pulmonary atelectasis is a commonly used procedure
for patients with acute respiratory distress syndrome (ARDS) to restore lung volume and
improve atelectasis. Therefore, it is worth exploring whether adopting recruitment maneuver
after bronchoscopy can avoid or reduce the problems of subsequent lung collapse and
atelectasis in patients, and how to quantify it.
electrical impedance tomography, referred to as EIT, is a new imaging technology that can be
implemented at the bedside in real-time, non-invasive and radiation free. The basic principle
is to apply a weak current through local electrodes to sense the changes in the chest
bioelectrical impedance during breathing, and then use the corresponding imaging algorithm to
monitor the status of ventilation function in different areas of the lung, which is presented
in real-time dynamic lung tomography ventilation images. Previous studies have found that
through EIT, the end expiratory lung impedance (EELI) of the lungs can be monitored,
indirectly reflecting the end expiratory volume of the lungs, thereby achieving the goal of
monitoring local lung collapse caused by fiberoptic bronchoscope.
After being included in the patient, the EIT chest strap was worn to measure the end
expiratory lung impedance and tidal impedance variable before bronchoscopy, and recorded as
EELI before and TIV before, global inhomogeneity (GI) index ,Center of Ventilation (CoV), the
vital signs of patients, including heart rate, blood pressure, respiratory rate, SpO2,
ventilator parameters, including mode, PC/Vt, FiO2, PEEP, and lung compliance before
bronchoscopy were recorded. Prepare fiber bronchoscopy and perform fiber bronchoscopy
according to routine procedures in ICU. Record the duration of fiberoptic bronchoscopy
examination and the condition of secretions.
After the fiber bronchoscopy examination, the end expiratory lung impedance and tidal
impedance variables were recorded as EELI after operation and TIV after operation. The GI
index, CoV, vital signs of patients, including heart rate, blood pressure, respiratory rate,
SpO2, ventilator parameters, including mode, PC/Vt, FiO2, PEEP, and compliance were recorded.
Perform recruitment maneuver using PCV mode, PEEP 20 cmH2O, PC 20 cmH2O, for 1 minute, then
gradually reduce the ventilator pressure and restore the mode and parameters before
bronchoscopy. If complications occur during the process of recruitment maneuver, timely
record them. End expiratory lung impedance and tidal impedance variables were recorded as
EELI after recruitment and TIV after recruitment. The GI index, CoV, vital signs of patients,
including heart rate, blood pressure, respiratory rate, SpO2, ventilator parameters,
including mode, PC/Vt, FiO2, PEEP, and compliance were recorded.