COPDNCT04798118
Role of Toilet Bronchoscopy in RICU
A study testing toilet bronchoscope in people with COPD and Asthma, run by Assiut University at 1 site in Egypt.
Trial summary
Toilet bronchoscopy is a potentially therapeutic intervention to aspirate retained secretions within the endotracheal tube and airways and revert atelectasis. Aspiration of airway secretions is the most common indication to perform a therapeutic bronchoscopy in the intensive care unit (ICU) . Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COPD, Asthma, Cystic Fibrosis
- What is being tested?
- toilet bronchoscope
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to Dec 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Patients on mechanical ventilation with underlying dieases that are characterized with mucus overproduction such as asthma, chronic obstructive pulmonary disease (COPD), bronchiectasis, and cystic fibrosis.
- Patients on mechanical ventilation with visible large amount of sputum during suction in order to clear secretions.
- Patients on mechanical ventilation with radiologically diagnosed atelectasis and absent air-bronchograms
- Patient on NIV who was benefit from toilet bronchoscopy to clear retained secretion.
Who cannot join
- Absence of consent from the patient or his/her representative.
- Inability to adequately oxygenate the patient during the procedure.
- Current myocardial ischaemia.
- Significant haemodynamic instability.
- Life-threatening cardiac arrhythmias.
- Current significant bronchospasm.
Show all 16Show fewer
- Undrained pneumothorax.
- Relative contraindications
- Thrombocytopenia (platelet count ≤50,000 platelets/mm).
- INR of 2 or greater, or an elevated PTT.
- BUN >30.
- severe tracheal obstruction.
- Recent myocardial ischaemia and/or unstable angina.
- Intracranial hypertension.
- Poorly-controlled heart failure.
- Recent oral intake.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assuit university hospital
Asyut, 71511
Shimaa A Mohammed, 01016599093, drshimaalimohammed@gmail.com
About this study
Official title: A Study on Toilet Bronchoscopy In Respiratory ICU, Assiut University Hospital
Toilet bronchoscopy is a potentially therapeutic intervention to aspirate retained secretions within the endotracheal tube and airways and revert atelectasis. Aspiration of airway secretions is the most common indication to perform a therapeutic bronchoscopy in the intensive care unit (ICU) .
Toilet bronchoscopy is particularly beneficial when retained secretions are visible during the procedure and when air-bronchograms are not present at the chest radiograph. It is also beneficial when there is an indication to reverse lobar atelectasis, rather than simply to remove accumulated mucus.
Read more
Toilet bronchoscopy is used in lobar and complete lung collapse in mechanically ventilated patients who fail to respond to treatments such as physiotherapy or recruitment manoeuvres.
The success rates (defined as radiographic improvement on chest X-ray [CXR] or an improved PaO2/PAO2 ratio) in the ICU patient population had.
Patients with acute hypoxaemic respiratory failure may already be on non-invasive ventilation (NIV), or require NIV preemptively for Fiberoptic Bronchoscopy (FB). These patients should be considered high risk for requiring intubation post-procedure; therefore, Fiberoptic Bronchoscopy should be performed by an experienced operator in a setting allowing facilities to safely secure the airways. NIV with early therapeutic FB rather than mechanical ventilation can help avoid intubation and reduce tracheostomy rate. Hospital mortality, duration of ventilation, and hospital stay remain similar
Read the detailed description
Aim Of Work To study the value of toilet bronchoscopy in
- Mechanical ventilated patients with chest disease and copious secretion.
- Mechanical ventilated patients diagnosed to have atelectasis radiologically.
- Patients on non-invasive ventilation with chest diseases and copious secretion
- Compare Different types of mucolytics during toilet bronchoscopy in mechanically ventilated patients.
- Compare Different types of sedations during toilet bronchoscopy in mechanically ventilated patients.
- Conditions
- COPD, Asthma, Cystic Fibrosis
- Being tested
- toilet bronchoscope
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
toilet bronchoscopeProcedure or surgery
Toilet bronchoscopy will be done by infuse normal saline or N-Acetylcysteine with a syringe, observing the flow of saline at the distal tip of the bronchoscope then suction intra bronchial visible secretions during the procedure and also suction of specific lobe guided by radiological finding in the patient A chest X-ray will be routinely performed prior and after the procedure, HRCT is mandatory when chest x-ray not clearly defining the collapse monitoring of heart rate, oxygen saturation, ventilator parameters, and arterial blood pressure will be done
| Study group | Role | What they receive |
|---|---|---|
| group treated with toilet bronchoscope | Experimental | Toilet bronchoscopy will be done as supportive care to sixty five (COPD,asthma,cystic bronchiectasis ) mechanically ventilated patients who fulfill the following criteria :
1. Copious secretion
2. Radiologically diagnosed atelectasis and absent air-bronchograms. Standard care of treatment will be carried out then assessment of a radiological, gasometric improvement and lung mechanics changes. Receives: Procedure: toilet bronchoscope |
| group treated with standered care | Active comparator | sixty five (COPD,asthma,cystic bronchiectasis ) mechanically ventilated patients who fulfill the following criteria :
1. Copious secretion
2. Radiologically diagnosed atelectasis and absent air-bronchograms. Standard care of treatment will be carried out then assessment of a radiological, gasometric improvement and lung mechanics changes. Receives: Procedure: toilet bronchoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
1- percent of patients develop radiological improvement
assessed improvement of atelectasis by chest x-ray or HRCT
Measured: 12 months
2- improvement of hypoxemia
assessed by sao2/fio2 or pao2/fio2 before and after procedure
Measured: 12months
3-Lung mechanics reduction post procedure in mechanical ventilated patients
resistance measured by cm H2o /Liter/ second
Measured: 12 months
Lung mechanics improvement post procedure in mechanical ventilated patients
assessed by static compliance measured by ml/cm H2o
Measured: 12 months
Secondary outcomes (4)
length of ICU stay
measured by days
Measured: 12 months
length of hospital stay
measured by days
Measured: 12 months
occurrence of complications
developed or not
Measured: 12 months
4-Hospital mortality
percent in each group
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start1 Apr 2022
- Primary completionOct 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Ali Mohammed, Assiut University
- Investigators
- Saher f youssif, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798118
- Sponsor's protocol ID
- Toilet Bronchoscope
- Status last verified
- Aug 2022
- First submitted
- 8 Mar 2021
- Last updated
- 15 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Marini JJ, Pierson DJ, Hudson LD. Acute lobar atelectasis: a prospective comparison of fiberoptic bronchoscopy and respiratory therapy. Am Rev Respir Dis. 1979 Jun;119(6):971-8. doi: 10.1164/arrd.1979.119.6.971.
PubMed 453712Snow N, Lucas AE. Bronchoscopy in the critically ill surgical patient. Am Surg. 1984 Aug;50(8):441-5.
PubMed 6465691Kreider ME, Lipson DA. Bronchoscopy for atelectasis in the ICU: a case report and review of the literature. Chest. 2003 Jul;124(1):344-50. doi: 10.1378/chest.124.1.344.
PubMed 12853543Jelic S, Cunningham JA, Factor P. Clinical review: airway hygiene in the intensive care unit. Crit Care. 2008;12(2):209. doi: 10.1186/cc6830. Epub 2008 Mar 31.
PubMed 18423061Jose RJ, Shaefi S, Navani N. Sedation for flexible bronchoscopy: current and emerging evidence. Eur Respir Rev. 2013 Jun 1;22(128):106-16. doi: 10.1183/09059180.00006412.
PubMed 23728864
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Toilet Bronchoscopy In Respiratory ICU, Assiut University Hospital
- ClinicalTrials.gov ID
- NCT04798118
- Acronym / sponsor ID
- Toilet Bronchoscope
- Conditions
- COPD, Asthma, Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 15 Mar 2021 (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.
Toilet bronchoscopy is a potentially therapeutic intervention to aspirate retained secretions within the endotracheal tube and airways and revert atelectasis. Aspiration of airway secretions is the most common indication to perform a therapeutic bronchoscopy in the intensive care unit (ICU) .
Toilet bronchoscopy is particularly beneficial when retained secretions are visible during the procedure and when air-bronchograms are not present at the chest radiograph. It is also beneficial when there is an indication to reverse lobar atelectasis, rather than simply to remove accumulated mucus.
Toilet bronchoscopy is used in lobar and complete lung collapse in mechanically ventilated patients who fail to respond to treatments such as physiotherapy or recruitment manoeuvres.
The success rates (defined as radiographic improvement on chest X-ray [CXR] or an improved PaO2/PAO2 ratio) in the ICU patient population had.
Patients with acute hypoxaemic respiratory failure may already be on non-invasive ventilation (NIV), or require NIV preemptively for Fiberoptic Bronchoscopy (FB). These patients should be considered high risk for requiring intubation post-procedure; therefore, Fiberoptic Bronchoscopy should be performed by an experienced operator in a setting allowing facilities to safely secure the airways. NIV with early therapeutic FB rather than mechanical ventilation can help avoid intubation and reduce tracheostomy rate. Hospital mortality, duration of ventilation, and hospital stay remain similar
Detailed description
Aim Of Work To study the value of toilet bronchoscopy in
- Mechanical ventilated patients with chest disease and copious secretion.
- Mechanical ventilated patients diagnosed to have atelectasis radiologically.
- Patients on non-invasive ventilation with chest diseases and copious secretion
- Compare Different types of mucolytics during toilet bronchoscopy in mechanically ventilated patients.
- Compare Different types of sedations during toilet bronchoscopy in mechanically ventilated patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group treated with toilet bronchoscope | Experimental | Procedure: toilet bronchoscopeToilet bronchoscopy will be done as supportive care to sixty five (COPD,asthma,cystic bronchiectasis ) mechanically ventilated patients who fulfill the following criteria : 1. Copious secretion 2. Radiologically diagnosed atelectasis and absent air-bronchograms. Standard care of treatment will be carried out then assessment of a radiological, gasometric improvement and lung mechanics changes. |
| group treated with standered care | Active comparator | Procedure: toilet bronchoscopesixty five (COPD,asthma,cystic bronchiectasis ) mechanically ventilated patients who fulfill the following criteria : 1. Copious secretion 2. Radiologically diagnosed atelectasis and absent air-bronchograms. Standard care of treatment will be carried out then assessment of a radiological, gasometric improvement and lung mechanics changes. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Patients on mechanical ventilation with underlying dieases that are characterized with mucus overproduction such as asthma, chronic obstructive pulmonary disease (COPD), bronchiectasis, and cystic fibrosis.
Key exclusion criteria (16 listed)
- Absence of consent from the patient or his/her representative.
- Inability to adequately oxygenate the patient during the procedure.
- Current myocardial ischaemia.
- Significant haemodynamic instability.
- Life-threatening cardiac arrhythmias.
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 |
|---|---|---|
| toilet bronchoscopeToilet bronchoscopy will be done by infuse normal saline or N-Acetylcysteine with a syringe, observing the flow of saline at the distal tip of the bronchoscope then suction intra bronchial visible secretions during the procedure and also suction of specific lobe guided by radiological finding in the patient A chest X-ray will be routinely performed prior and after the procedure, HRCT is mandatory when chest x-ray not clearly defining the collapse monitoring of heart rate, oxygen saturation, ventilator parameters, and arterial blood pressure will be done | Procedure or surgery | group treated with standered care, group treated with toilet bronchoscope |
Primary outcome
1- percent of patients develop radiological improvement
Time frame: 12 months
assessed improvement of atelectasis by chest x-ray or HRCT
2- improvement of hypoxemia
Time frame: 12months
assessed by sao2/fio2 or pao2/fio2 before and after procedure
3-Lung mechanics reduction post procedure in mechanical ventilated patients
Time frame: 12 months
resistance measured by cm H2o /Liter/ second
Lung mechanics improvement post procedure in mechanical ventilated patients
Time frame: 12 months
assessed by static compliance measured by ml/cm H2o
4 secondary outcomes
length of ICU stay
Time frame: 12 months
length of hospital stay
Time frame: 12 months
occurrence of complications
Time frame: 12 months
4-Hospital mortality
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Background: PubMed 453712Marini JJ, Pierson DJ, Hudson LD. Acute lobar atelectasis: a prospective comparison of fiberoptic bronchoscopy and respiratory therapy. Am Rev Respir Dis. 1979 Jun;119(6):971-8. doi: 10.1164/arrd.1979.119.6.971.
- Background: PubMed 6465691Snow N, Lucas AE. Bronchoscopy in the critically ill surgical patient. Am Surg. 1984 Aug;50(8):441-5.
- Background: PubMed 12853543Kreider ME, Lipson DA. Bronchoscopy for atelectasis in the ICU: a case report and review of the literature. Chest. 2003 Jul;124(1):344-50. doi: 10.1378/chest.124.1.344.
- Background: PubMed 18423061Jelic S, Cunningham JA, Factor P. Clinical review: airway hygiene in the intensive care unit. Crit Care. 2008;12(2):209. doi: 10.1186/cc6830. Epub 2008 Mar 31.
- Background: PubMed 23728864Jose RJ, Shaefi S, Navani N. Sedation for flexible bronchoscopy: current and emerging evidence. Eur Respir Rev. 2013 Jun 1;22(128):106-16. doi: 10.1183/09059180.00006412.
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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.
Saher f youssif principal investigator
Assiut 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 toilet bronchoscope in people with COPD and Asthma, run by Assiut University at 1 site in Egypt.
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 4 inclusion and 16 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 15 Aug 2023. 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 Egypt. 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 Shaimaa A Mohammed, MD (01016599093, drshimaalimohammed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1- percent of patients develop radiological improvement (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04798118, which also lists 5 linked publications.
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 15 Aug 2023.