Role of Toilet Bronchoscopy in RICU

Not Applicable

• Conditions: Asthma; Cystic Fibrosis; COPD
• Interventions: Procedure: toilet bronchoscope

• Registration Number: NCT04798118
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study First Submitted: 2021-03-08
• Study First Submitted QC: 2021-03-11
• Study First Posted: 2021-03-15
• Study Start: 2022-04-01
• Status Verified: 2022-08
• Last Update Submitted: 2023-08-13
• Last Update Posted: 2023-08-15
• Primary Completion: 2023-10
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group treated with toilet bronchoscope	toilet bronchoscope	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.
group treated with standered care	toilet bronchoscope	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.

Primary Outcome Measures

Name	Time	Method
3-Lung mechanics reduction post procedure in mechanical ventilated patients	12 months	resistance measured by cm H2o /Liter/ second
1- percent of patients develop radiological improvement	12 months	assessed improvement of atelectasis by chest x-ray or HRCT
2- improvement of hypoxemia	12months	assessed by sao2/fio2 or pao2/fio2 before and after procedure
Lung mechanics improvement post procedure in mechanical ventilated patients	12 months	assessed by static compliance measured by ml/cm H2o

Secondary Outcome Measures

Name	Time	Method
length of hospital stay	12 months	measured by days
4-Hospital mortality	12 months	percent in each group
length of ICU stay	12 months	measured by days
occurrence of complications	12 months	developed or not

Trial Locations

Locations (1)

Assuit university hospital; 🇪🇬 Assiut, Egypt