Clinical trial NCT04798118: Role of Toilet Bronchoscopy in RICU
Official title: A Study on Toilet Bronchoscopy In Respiratory ICU, Assiut University Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD
Asthma
Cystic Fibrosis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-03-15
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 1- percent of patients develop radiological improvement
timeFrame: 12 months
measure: 2- improvement of hypoxemia
timeFrame: 12months
measure: 3-Lung mechanics reduction post procedure in mechanical ventilated patients
timeFrame: 12 months
measure: Lung mechanics improvement post procedure in mechanical ventilated patients
timeFrame: 12 months
Secondary outcomes:
measure: length of ICU stay
timeFrame: 12 months
measure: length of hospital stay
timeFrame: 12 months
measure: occurrence of complications
timeFrame: 12 months
measure: 4-Hospital mortality
timeFrame: 12 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assuit university hospital
Study officials:
affiliation: Assiut University
name: Saher f youssif
role: PRINCIPAL_INVESTIGATOR
References:
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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.
citation: 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.
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.