Role of Toilet Bronchoscopy in RICU

NCT04798118 | Unknown

• 1 other identifier: Toilet Bronchoscope
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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

Conditions

COPD; Asthma; Cystic Fibrosis

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• length of ICU stay

  12 months

• length of hospital stay

  12 months

• occurrence of complications

  12 months

• 4-Hospital mortality

  12 months

Study Arms (2)

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.

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.

Procedure: toilet bronchoscope

Interventions

toilet bronchoscope PROCEDURE

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

group treated with standered care; group treated with toilet bronchoscope

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assuit university hospital

Asyut, 71511, Egypt

RECRUITING

Related Publications (5)

• 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.

  PMID: 453712 BACKGROUND

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

  PMID: 6465691 BACKGROUND

• 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.

  PMID: 12853543 BACKGROUND

• 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.

  PMID: 18423061 BACKGROUND

• 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.

  PMID: 23728864 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma; Cystic Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pancreatic Diseases; Digestive System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Saher f youssif

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shaimaa A Mohammed, MD

CONTACT

01016599093; drshimaalimohammed@gmail.com

Saher f youssif

CONTACT

01002976708; Saherfr2009@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer,chest department and tuberculosis

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 15, 2021
• Study Start: April 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 15, 2023

Record last verified: 2022-08

Locations

EG (1)