Role of Toilet Bronchoscopy in RICU

NCT ID: NCT04798118

Last Updated: 2023-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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COPD Asthma Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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 :

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 Type EXPERIMENTAL

toilet bronchoscope

Intervention Type 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

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 Type ACTIVE_COMPARATOR

toilet bronchoscope

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Shaimaa Ali Mohammed

Assistant lecturer,chest department and tuberculosis

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Saher f youssif

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

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Assuit university hospital

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Shaimaa A Mohammed, MD

Role: CONTACT

01016599093

Saher f youssif

Role: CONTACT

01002976708

Facility Contacts

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Shimaa A Mohammed

Role: primary

01016599093

References

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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.

Reference Type BACKGROUND
PMID: 453712 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 6465691 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12853543 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18423061 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23728864 (View on PubMed)

Other Identifiers

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Toilet Bronchoscope

Identifier Type: -

Identifier Source: org_study_id

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