Non-invasive Ventilation Assisted Fiber-optic Bronchoscopy

Mansoura University

Status: Enrolling

Conditions: Diseases; Lung

Treatments: Device: non- invasive ventilator; Device: fiber-optic bronchoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT06115395

Bronchoscopy with NIV

Details and patient eligibility

About

The purpose of this study is the evaluation of using bi-level positive airway pressure ventilation in candidates for fiber-optic bronchoscopy regarding benefits and drawbacks.

Full description

In this study patients who will be candidate for fiber-optic bronchoscopy for diagnostic or therapeutic reasons will be evaluated by the Chest Medicine Department, Mansoura University Hospitals. All patients will be subjected to full history taking, full examination, routine laboratory investigations, arterial blood gases (ABG), chest X-ray, chest computed tomography (CT). Non-invasive ventilation: Group 1 (hypoexemic patient who will undergo bronchoscopy under non- invasive ventilation{NIV}) will be on NIV half an hour prior and throughout the bronchoscopic sampling and after the procedure until reach the baseline criteria, Group 2 (hypoxemic patients who will undergo conventional bronchoscopy ) will be on conventional oxygen therapy half an hour prior and throughout the bronchoscopic sampling and after the procedure until reach the baseline criteria, Group 3 (non- hypoxemic patients who will undergo conventional bronchoscopy ) will be on NIV throughout the bronchoscopic sampling and after the procedure until reach the baseline criteria, Group 4 (non- hypoxemic patients who will undergo conventional bronchoscopy) will be on conventional oxygen therapy throughout the bronchoscopic sampling and after the procedure until reach the baseline criteria.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who admitted to the pulmonology ward or intensive care unit with any (diagnostic and/or therapeutic) bronchoscopy indication.

  1. Age 18 years or more.
  2. Patients accepted to participate in the study.

Exclusion criteria

• Patients with:

  1. Cardiac or respiratory arrest.
  2. Impaired consciousness or confusion.
  3. Type II respiratory failure.
  4. Hemodynamic instability.
  5. Inability to cooperate or to protect the airway.
  6. Vomiting, bowel obstruction, recent upper gastrointestinal tract surgery and esophageal injury.
  7. Patients refusing participation in the study.
  8. Patients unfit for NIV and or NIV mask.
  9. Intubation and or invasive ventilation candidates.
  10. Presence of contraindications for bronchoscopy procedure such as insufficient platelet number or coagulopathy.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 4 patient groups

(Group 1) 25 (H. NIV): Hypoxemic patients{hypoxemic NIV group}

Active Comparator group

Description:

who will undergo fiber-optic bronchoscopy under non- invasive ventilation and conventional oxygen therapy

Treatment:

Device: non- invasive ventilator

Device: fiber-optic bronchoscopy

Device: non- invasive ventilator

Device: fiber-optic bronchoscopy

(Group 2) 25 (H. conv.): Hypoxemic patients{hypoxemic conventional group }

Active Comparator group

Description:

who will undergo conventional fiber-optic bronchoscopy under conventional oxygen therapy without non- invasive ventilation

Treatment:

Device: fiber-optic bronchoscopy

Device: fiber-optic bronchoscopy

(Group 3) 25 (N.H.NIV): Non- hypoxemic patients{non-hypoxemic NIV group}

Active Comparator group

Description:

who will undergo fiber-optic bronchoscopy under non- invasive ventilation and conventional oxygen therapy

Treatment:

Device: non- invasive ventilator

Device: fiber-optic bronchoscopy

Device: non- invasive ventilator

Device: fiber-optic bronchoscopy

(Group 4) 25(N.H. conv.): Non- hypoxemic patients{non-hypoxemic conventional group}

Active Comparator group

Description:

who will undergo conventional fiber-optic bronchoscopy under conventional oxygen therapy without non- invasive ventilation

Treatment:

Device: fiber-optic bronchoscopy

Device: fiber-optic bronchoscopy