BronchoscopyNCT05875662
Pulmonary Ventilation After Fiberoptic Bronchoscopy Using EIT
An observational study of Bronchoscopy and Atelectasis, run by Peking University People's Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Bronchoscopy, Atelectasis, Mechanical Ventilation
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 5 May 2023to 31 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Invasive mechanical ventilation patients admitted to the ICU who plan to undergo bedside fiberoptic bronchoscopy
Who may be able to join
- Patients with invasive mechanical ventilation undergoing fiberoptic bronchoscopy in ICU
Who cannot join
- Age<18 years old or>85 years old
- Pregnant women
- Patients undergoing emergency bronchoscopy examination
- Patients who undergo bronchoscopy only to confirm the position of the artificial airway
- Patients who are unable to wear EIT chest straps due to surgical incisions or closed drainage tubes in the chest
- Patients who refuse to participate in this trial
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Critical Care Medicine, Peking University People's Hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: Evaluation of Pulmonary Ventilation After Fiberoptic Bronchoscopy in Critically Ill Patients Using Electrical Impedance Tomography
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.
Read the detailed 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.
- Conditions
- Bronchoscopy, Atelectasis, Mechanical Ventilation
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mechanical ventilation patients undergoing fiberoptic bronchoscopy | After being included in the patient, the EIT chest strap was worn to measure the end expiratory lung impedance and tidal impedance variable, assess the distribution of lung ventilation in patients and record GI index and CoV. EELI,TIV, GI index, CoV, vital signs of patients, including heart rate, blood pressure, respiratory rate, SpO2, ventilator parameters, including mode, driving pressure, FiO2, PEEP, and lung compliance was recorded before and after bronchoscopy. Patients underwent a recruitment maneuver 5 minutes after bronchoscopy maintaining breaths at a PC of 40 cm H2O with PEEP of 20 cm H2O in pressure control mode for 1 minute, then, PEEP was decreased from 20 to preceding PEEP value in steps of 2 cm H2O with a duration of at least 10 breaths or 30 seconds at each step. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in end-expiratory lung impedance (ΔEELI)
EIT was performed with a PulmoVista 500(Drager Medical, Lübeck, Germany).The signals were recorded and later reviewed offline using a dedicated software program (Dräger Medical GmbH EIT data analysis version 6.3).ΔEELI refers to differences in end-expiration lung impedance between 5 minutes before and 5 minutes after lung recruitment maneuver.
Measured: Changes in EELI within 5 minutes before and 5 minutes after lung recruitment maneuver
The change in tidal impedance variable (ΔTIV)
TIV, which correlates with gas volume changes in the lung, was calculated by selecting 10 subsequent breathing cycles from the recorded EIT sequences. Thereafter, differences in global impedance between end-inspiration and end-expiration were calculated, then averaged.ΔTIV is the change in TIV within 5 minutes before and 5 minutes after lung recruitment maneuver
Measured: Changes in TIV within 5 minutes before and 5 minutes after lung recruitment maneuver
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start5 May 2023
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shan Lv, Peking University People's Hospital
- Investigators
- Shan Lyu, Master, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05875662
- Sponsor's protocol ID
- PekingUPH-2023z038
- Status last verified
- Apr 2024
- First submitted
- 7 May 2023
- Last updated
- 26 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pulmonary Ventilation After Fiberoptic Bronchoscopy in Critically Ill Patients Using Electrical Impedance Tomography
- ClinicalTrials.gov ID
- NCT05875662
- Acronym / sponsor ID
- PekingUPH-2023z038
- Conditions
- Bronchoscopy, Atelectasis, Mechanical Ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 5 May 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 25 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mechanical ventilation patients undergoing fiberoptic bronchoscopy | – | –After being included in the patient, the EIT chest strap was worn to measure the end expiratory lung impedance and tidal impedance variable, assess the distribution of lung ventilation in patients and record GI index and CoV. EELI,TIV, GI index, CoV, vital signs of patients, including heart rate, blood pressure, respiratory rate, SpO2, ventilator parameters, including mode, driving pressure, FiO2, PEEP, and lung compliance was recorded before and after bronchoscopy. Patients underwent a recruitment maneuver 5 minutes after bronchoscopy maintaining breaths at a PC of 40 cm H2O with PEEP of 20 cm H2O in pressure control mode for 1 minute, then, PEEP was decreased from 20 to preceding PEEP value in steps of 2 cm H2O with a duration of at least 10 breaths or 30 seconds at each step. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Invasive mechanical ventilation patients admitted to the ICU who plan to undergo bedside fiberoptic bronchoscopy
Key inclusion criteria (1 listed)
- Patients with invasive mechanical ventilation undergoing fiberoptic bronchoscopy in ICU
Key exclusion criteria (6 listed)
- Age<18 years old or>85 years old
- Pregnant women
- Patients undergoing emergency bronchoscopy examination
- Patients who undergo bronchoscopy only to confirm the position of the artificial airway
- Patients who are unable to wear EIT chest straps due to surgical incisions or closed drainage tubes in the chest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The change in end-expiratory lung impedance (ΔEELI)
Time frame: Changes in EELI within 5 minutes before and 5 minutes after lung recruitment maneuver
EIT was performed with a PulmoVista 500(Drager Medical, Lübeck, Germany).The signals were recorded and later reviewed offline using a dedicated software program (Dräger Medical GmbH EIT data analysis version 6.3).ΔEELI refers to differences in end-expiration lung impedance between 5 minutes before and 5 minutes after lung recruitment maneuver.
The change in tidal impedance variable (ΔTIV)
Time frame: Changes in TIV within 5 minutes before and 5 minutes after lung recruitment maneuver
TIV, which correlates with gas volume changes in the lung, was calculated by selecting 10 subsequent breathing cycles from the recorded EIT sequences. Thereafter, differences in global impedance between end-inspiration and end-expiration were calculated, then averaged.ΔTIV is the change in TIV within 5 minutes before and 5 minutes after lung recruitment maneuver
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shan Lyu, Master principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchoscopy and Atelectasis, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in end-expiratory lung impedance (ΔEELI) (time frame: Changes in EELI within 5 minutes before and 5 minutes after lung recruitment maneuver). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.