Role of Toilet Bronchoscopy in RICU

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.

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

Study Overview

• Status: Recruiting
• Conditions: Asthma; Cystic Fibrosis; COPD
• Intervention / Treatment: Procedure: toilet bronchoscope

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 Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shaimaa A Mohammed, MD; Phone Number: 01016599093; Email: drshimaalimohammed@gmail.com
• Study Contact Backup: Name: Saher f youssif; Phone Number: 01002976708; Email: Saherfr2009@yahoo.com

Study Locations

• Egypt
  • Assiut, Egypt, 71511
    • Recruiting
    • Assuit University Hospital
    • Contact: Shimaa A Mohammed; Phone Number: 01016599093; Email: drshimaalimohammed@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group treated with 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 : Copious secretion; 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.	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
Active Comparator: group treated with standered care; sixty five (COPD,asthma,cystic bronchiectasis ) mechanically ventilated patients who fulfill the following criteria : Copious secretion; 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.	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Saher f youssif, Assiut University

Publications and helpful links

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

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Estimated): October 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: March 8, 2021
• First Submitted That Met QC Criteria: March 11, 2021
• First Posted (Actual): March 15, 2021

Study Record Updates

• Last Update Posted (Actual): August 15, 2023
• Last Update Submitted That Met QC Criteria: August 13, 2023
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Cystic Fibrosis
• Other Study ID Numbers: Toilet Bronchoscope

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No