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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04798118
Other study ID # Toilet Bronchoscope
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2022
Est. completion date December 2023

Study information

Verified date August 2022
Source Assiut University
Contact Shaimaa A Mohammed, MD
Phone 01016599093
Email drshimaalimohammed@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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) . 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


Description:

Aim Of Work To study the value of toilet bronchoscopy in 1. Mechanical ventilated patients with chest disease and copious secretion. 2. Mechanical ventilated patients diagnosed to have atelectasis radiologically. 3. Patients on non-invasive ventilation with chest diseases and copious secretion 4. Compare Different types of mucolytics during toilet bronchoscopy in mechanically ventilated patients. 5. Compare Different types of sedations during toilet bronchoscopy in mechanically ventilated patients.


Recruitment information / eligibility

Status Recruiting
Enrollment 130
Est. completion date December 2023
Est. primary completion date October 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - • 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. Exclusion Criteria:Absolute contraindications - 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. - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
toilet bronchoscope
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

Locations

Country Name City State
Egypt Assuit university hospital Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

Jelic 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. — View Citation

Jose 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. — View Citation

Kreider 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. — View Citation

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. — View Citation

Snow N, Lucas AE. Bronchoscopy in the critically ill surgical patient. Am Surg. 1984 Aug;50(8):441-5. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 1- percent of patients develop radiological improvement assessed improvement of atelectasis by chest x-ray or HRCT 12 months
Primary 2- improvement of hypoxemia assessed by sao2/fio2 or pao2/fio2 before and after procedure 12months
Primary 3-Lung mechanics reduction post procedure in mechanical ventilated patients resistance measured by cm H2o /Liter/ second 12 months
Primary Lung mechanics improvement post procedure in mechanical ventilated patients assessed by static compliance measured by ml/cm H2o 12 months
Secondary length of ICU stay measured by days 12 months
Secondary length of hospital stay measured by days 12 months
Secondary occurrence of complications developed or not 12 months
Secondary 4-Hospital mortality percent in each group 12 months
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