Clinical trial NCT06115395: Non-invasive Ventilation Assisted Fiber-optic Bronchoscopy
Official title: Efficacy and Safety of Using Non-invasive Ventilation Assisted Fiber-optic Bronchoscopy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung
Diseases
Keywords: non- invasive ventilation
fiber-optic bronchoscopy.
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of the changes in oxygen saturation, heart rate, respiratory rate, blood pressure, dyspnea score and arterial blood gases in bronchoscopy procedure
timeFrame: 4 years
Secondary outcomes:
measure: Fiber-optic bronchoscopy complications
timeFrame: 4 years
Other outcomes:
Locations:
city: El Mansura
country: Egypt
facility: Walaa Maher Abd ElAziz,
Study officials:
affiliation: Mansoura University
name: Ahmed El sayed, MD
role: STUDY_CHAIR
affiliation: Mansoura University
name: Amr Moawad, MD
role: STUDY_DIRECTOR
affiliation: Mansoura University
name: Mohamed Mansour, MD
role: STUDY_DIRECTOR
References:
citation: 1. Biswas A, Mehta H, Sriram P. Diagnostic Yield of the Virtual Bronchoscopic Navigation System Guided Sampling of Peripheral Lung Lesions using Ultrathin Bronchoscope and Protected Bronchial Brush. Turk Thorac J. 2019; 01; 20(1):6-11. 2. Campos JH. Fiberoptic bronchoscopy guidelines for the anesthesiologist. Revista Mexicana de Anestesiología. 2011; 31: S264-9. 3. Hilbert G, Gruson D, Vargas F, Valentino R, Favier JC, Portel L, et al. Bronchoscopy with bronchoalveolar lavage via the laryngeal mask airway in high-risk hypoxemic immunosuppressed patients. Crit Care Med. 2001; 29: 249-255. 4. Schönhofer B, Kuhlen R, Neumann P, et al. Non-invasive ventilation as treatment for acute respiratory insufficiency. Essentials from the new S3 guidelines. Anaesthesist. 2008; 57: 1091-102.