Acute Respiratory FailureNCT05200494
Lung Aeration After Flexible Bronchoscopy in Intubated Critically Ill Patients
A study testing Recruiting Maneuver in people with Acute Respiratory Failure, run by University Magna Graecia at 1 site in Italy.
Trial summary
In patients suffering from acute respiratory failure, ineffective cough and the consequent retention of secretions are common clinical problems, which often lead to the need for tracheostomy for the sole purpose of aspiration of secretions from the airways. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- Recruiting Maneuver
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2022to 31 Dec 2022
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- invasive mechanical ventilation
- need for flexible bronchoscopy to remove secretion plug from the airway
Who cannot join
- hemodynamic instability, (i.e. systolic arterial pressure <90 mmHg or mean systolic pressure <65 mmHg despite fluid repletion);
- need for vasoactive agents, i.e. vasopressin or epinephrine at any dosage, or norepinephrine >0.3 mcg/kg/min or dobutamine>5 mcg/kg/min;
- life-threatening arrhythmias or electrocardiographic signs of ischemia;
- contraindications to placement of Electrical Impedance Tomography belt, Lung UltraSound or application of a Recruiting Maneuver (i.e., pneumothorax, pulmonary emphysema, chest burns or thoracic surgery within 1 week);
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Lung Aeretion After Flexible Bronchoscopy for Secretion Removal in Intubated Critically Ill Patients Receiving or Not a Recruiting Maneuver Soon After the Procedure: an Observational Physiological Study
In patients suffering from acute respiratory failure, ineffective cough and the consequent retention of secretions are common clinical problems, which often lead to the need for tracheostomy for the sole purpose of aspiration of secretions from the airways.
Mechanically ventilated critically ill patients often have impaired mucus transport which is associated with secretion retention and subsequent development of pneumonia. The accumulation of tracheobronchial secretions in ventilated patients in ICU is due not only to an increased production, but also to a decreased clearance. In the event that secretions occlude a bronchus, an atelectasis of the lung parenchyma is created downstream. Therefore, it is often necessary to perform a flexible bronchoscopy (FOB) to proceed with the removal of the secretion plug. After its removal, the lung is supposed to be reventilated and recruited.
Read more
In intubated ICU patients, the application of a recruiting maneuver (RM) is commonly used to reopen the collapsed lung in patients with Acute Respiratory Distress Syndrome or in case of atelectasis in other clinical conditions. However, no studies have so far investigated the role of the application of a RM after a FOB performed to remove a secretion plug in intubated ICU patients.
This observational and physiological study aims to assess if the application of a RM would modify the lung aeration soon after an FOB to remove secretion plug (first outcome). Moreover, the study aims to assess if EIT could be an additional bedside imaging tool to monitor modifications of lung ventilation and aeration during and after a flexible bronchoscopy, as compared with both chest-X-ray and lung ultrasound.
- Conditions
- Acute Respiratory Failure
- Being tested
- Recruiting Maneuver
- Keywords
- Secretions, Bronchoscopy, Lung Ultrasound, Electrical Impedance Tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recruiting ManeuverProcedure or surgery
Airway pressure will be increased to 30 cmH2O for 30 seconds at the end of the bronchoscopy
| Study group | Role | What they receive |
|---|---|---|
| Flexible Bronchoscopy without Recruiting Maneuver | No intervention | At the end of the bronchoscopy, no further interventions or ventilator maneuvers will be done. |
| Flexible Bronchoscopy with Recruiting Maneuver | Experimental | At the end of the bronchoscopy, a recruiting maneuver will be applied to the patients. Recruiting Maneuver consists in the application of an airway pressure of 30 cmH2O for a period of 30 seconds. Receives: Procedure: Recruiting Maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Aeration through EIT
Improvement of lung aeration will be assess with End Expiratory Lung Impedance through Electrical Impedance Tomography, as compared to baseline (before the bronchoscopy)
Measured: One hour after the end of the bronchoscopy
Lung Aeration through Lung Ultrasound
Improvement of lung aeration will be assess with Lung Ultrasound Score, as compared to baseline (before the bronchoscopy)
Measured: One hour after the end of the bronchoscopy
Secondary outcomes (4)
Arterial Blood Gases
Arterial Blood Gases will be assessed through an arterial blood sample
Measured: Soon after the end of the bronchoscopy
Arterial Blood Gases
Arterial Blood Gases will be assessed through an arterial blood sample
Measured: One hour after the end of the bronchoscopy
Lung Aeration through EIT
Improvement of lung aeration will be assess with End Expiratory Lung Impedance through Electrical Impedance Tomography, as compared to baseline (before the bronchoscopy)
Measured: Soon after the end of the bronchoscopy
Lung Aeration through Lung Ultrasound
Improvement of lung aeration will be assess with Lung Ultrasound Score , as compared to baseline (before the bronchoscopy)
Measured: Soon after the end of the bronchoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start1 Feb 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to receive or not a Recruiting Maneuver (RM) at the end of the Flexible Bronchoscopy. RM will be performed by the application to the airways of 30 cmH2O positive pressure for 30 seconds.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Magna Graecia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Federico Longhini, University Magna Graecia
- Investigators
- Federico Longhini, MD, Principal investigator, Magna Graecia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200494
- Sponsor's protocol ID
- ICU Bronchoscopy
- Status last verified
- Jan 2022
- First submitted
- 6 Jan 2022
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymous data will be shared after study publication on a peer-reviewed journal in english language, on a reasonable request to the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Lung Aeretion After Flexible Bronchoscopy for Secretion Removal in Intubated Critically Ill Patients Receiving or Not a Recruiting Maneuver Soon After the Procedure: an Observational Physiological Study
- ClinicalTrials.gov ID
- NCT05200494
- Acronym / sponsor ID
- ICU Bronchoscopy
- Conditions
- Acute Respiratory Failure
- Keywords
- Secretions, Bronchoscopy, Lung Ultrasound, Electrical Impedance Tomography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Magna GraeciaUniversity, hospital or other
- Study start
- 1 Feb 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 20 Jan 2022 (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.
In patients suffering from acute respiratory failure, ineffective cough and the consequent retention of secretions are common clinical problems, which often lead to the need for tracheostomy for the sole purpose of aspiration of secretions from the airways.
Mechanically ventilated critically ill patients often have impaired mucus transport which is associated with secretion retention and subsequent development of pneumonia. The accumulation of tracheobronchial secretions in ventilated patients in ICU is due not only to an increased production, but also to a decreased clearance. In the event that secretions occlude a bronchus, an atelectasis of the lung parenchyma is created downstream. Therefore, it is often necessary to perform a flexible bronchoscopy (FOB) to proceed with the removal of the secretion plug. After its removal, the lung is supposed to be reventilated and recruited.
In intubated ICU patients, the application of a recruiting maneuver (RM) is commonly used to reopen the collapsed lung in patients with Acute Respiratory Distress Syndrome or in case of atelectasis in other clinical conditions. However, no studies have so far investigated the role of the application of a RM after a FOB performed to remove a secretion plug in intubated ICU patients.
This observational and physiological study aims to assess if the application of a RM would modify the lung aeration soon after an FOB to remove secretion plug (first outcome). Moreover, the study aims to assess if EIT could be an additional bedside imaging tool to monitor modifications of lung ventilation and aeration during and after a flexible bronchoscopy, as compared with both chest-X-ray and lung ultrasound.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomized to receive or not a Recruiting Maneuver (RM) at the end of the Flexible Bronchoscopy. RM will be performed by the application to the airways of 30 cmH2O positive pressure for 30 seconds.
| Arm | Type | Receives |
|---|---|---|
| Flexible Bronchoscopy without Recruiting Maneuver | No intervention | –At the end of the bronchoscopy, no further interventions or ventilator maneuvers will be done. |
| Flexible Bronchoscopy with Recruiting Maneuver | Experimental | Procedure: Recruiting ManeuverAt the end of the bronchoscopy, a recruiting maneuver will be applied to the patients. Recruiting Maneuver consists in the application of an airway pressure of 30 cmH2O for a period of 30 seconds. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- invasive mechanical ventilation
- need for flexible bronchoscopy to remove secretion plug from the airway
Key exclusion criteria (4 listed)
- hemodynamic instability, (i.e. systolic arterial pressure <90 mmHg or mean systolic pressure <65 mmHg despite fluid repletion);
- need for vasoactive agents, i.e. vasopressin or epinephrine at any dosage, or norepinephrine >0.3 mcg/kg/min or dobutamine>5 mcg/kg/min;
- life-threatening arrhythmias or electrocardiographic signs of ischemia;
- contraindications to placement of Electrical Impedance Tomography belt, Lung UltraSound or application of a Recruiting Maneuver (i.e., pneumothorax, pulmonary emphysema, chest burns or thoracic surgery within 1 week);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recruiting ManeuverAirway pressure will be increased to 30 cmH2O for 30 seconds at the end of the bronchoscopy | Procedure or surgery | Flexible Bronchoscopy with Recruiting Maneuver |
Primary outcome
Lung Aeration through EIT
Time frame: One hour after the end of the bronchoscopy
Improvement of lung aeration will be assess with End Expiratory Lung Impedance through Electrical Impedance Tomography, as compared to baseline (before the bronchoscopy)
Lung Aeration through Lung Ultrasound
Time frame: One hour after the end of the bronchoscopy
Improvement of lung aeration will be assess with Lung Ultrasound Score, as compared to baseline (before the bronchoscopy)
4 secondary outcomes
Arterial Blood Gases
Time frame: Soon after the end of the bronchoscopy
Arterial Blood Gases
Time frame: One hour after the end of the bronchoscopy
Lung Aeration through EIT
Time frame: Soon after the end of the bronchoscopy
Lung Aeration through Lung Ultrasound
Time frame: Soon after the end of the bronchoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
- Individual participant dataSharing planned: Yes. Anonymous data will be shared after study publication on a peer-reviewed journal in english language, on a reasonable request to the principal investigator
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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.
Federico Longhini, MD principal investigator
Magna Graecia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recruiting Maneuver in people with Acute Respiratory Failure, run by University Magna Graecia at 1 site in Italy.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 20 Jan 2022. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Federico Longhini, MD (+393475395967, longhini.federico@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung Aeration through EIT (time frame: One hour after the end of the bronchoscopy). 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 20 Jan 2022.