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Role of Toilet Bronchoscopy in RICU

Primary Purpose

COPD, Asthma, Cystic Fibrosis

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
toilet bronchoscope
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for COPD

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Assuit university hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

group treated with toilet bronchoscope

group treated with standered care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 8, 2021
Last Updated
August 13, 2023
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT04798118
Brief Title
Role of Toilet Bronchoscopy in RICU
Official Title
A Study on Toilet Bronchoscopy In Respiratory ICU, Assiut University Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 Mechanical ventilated patients with chest disease and copious secretion. Mechanical ventilated patients diagnosed to have atelectasis radiologically. Patients on non-invasive ventilation with chest diseases and copious secretion Compare Different types of mucolytics during toilet bronchoscopy in mechanically ventilated patients. Compare Different types of sedations during toilet bronchoscopy in mechanically ventilated patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Asthma, Cystic Fibrosis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group treated with toilet bronchoscope
Arm Type
Experimental
Arm Description
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.
Arm Title
group treated with standered care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
toilet bronchoscope
Intervention Description
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
Primary Outcome Measure Information:
Title
1- percent of patients develop radiological improvement
Description
assessed improvement of atelectasis by chest x-ray or HRCT
Time Frame
12 months
Title
2- improvement of hypoxemia
Description
assessed by sao2/fio2 or pao2/fio2 before and after procedure
Time Frame
12months
Title
3-Lung mechanics reduction post procedure in mechanical ventilated patients
Description
resistance measured by cm H2o /Liter/ second
Time Frame
12 months
Title
Lung mechanics improvement post procedure in mechanical ventilated patients
Description
assessed by static compliance measured by ml/cm H2o
Time Frame
12 months
Secondary Outcome Measure Information:
Title
length of ICU stay
Description
measured by days
Time Frame
12 months
Title
length of hospital stay
Description
measured by days
Time Frame
12 months
Title
occurrence of complications
Description
developed or not
Time Frame
12 months
Title
4-Hospital mortality
Description
percent in each group
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shaimaa A Mohammed, MD
Phone
01016599093
Email
drshimaalimohammed@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Saher f youssif
Phone
01002976708
Email
Saherfr2009@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saher f youssif
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assuit university hospital
City
Assiut
ZIP/Postal Code
71511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shimaa A Mohammed
Phone
01016599093
Email
drshimaalimohammed@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
453712
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.
Results Reference
background
PubMed Identifier
6465691
Citation
Snow N, Lucas AE. Bronchoscopy in the critically ill surgical patient. Am Surg. 1984 Aug;50(8):441-5.
Results Reference
background
PubMed Identifier
12853543
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.
Results Reference
background
PubMed Identifier
18423061
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.
Results Reference
background
PubMed Identifier
23728864
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.
Results Reference
background

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Role of Toilet Bronchoscopy in RICU

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