Non-invasive Ventilation Assisted Fiber-optic Bronchoscopy

Efficacy and Safety of Using Non-invasive Ventilation Assisted Fiber-optic Bronchoscopy

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.

Study Overview

• Status: Recruiting
• Conditions: Lung; Diseases
• Intervention / Treatment: Device: non- invasive ventilator; Device: fiber-optic bronchoscopy; Device: non- invasive ventilator; Device: fiber-optic bronchoscopy

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Walaa Abd El Aziz, MD; Phone Number: 01064904172; Email: Wm22446699@gmail.com
• Study Contact Backup: Name: Mohamed Mansour, MD; Phone Number: 01009400754; Email: Mohammedmansour.md@gmail.com

Study Locations

• Egypt
  • El Mansura, Egypt
    • Recruiting
    • Walaa Maher Abd ElAziz,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: (Group 1) 25 (H. NIV): Hypoxemic patients{hypoxemic NIV group}; who will undergo fiber-optic bronchoscopy under non- invasive ventilation and conventional oxygen therapy	Device: non- invasive ventilator; Group 1 (hypoexemic patient who will undergo bronchoscopy under non- invasive ventilation{NIV} and conventional o2 therapy) will be on NIV half an hour prior and throughout the bronchoscopic sampling and after the procedure until reach the baseline criteria; Other Names: conventional oxygen therapy; fiber-optic bronchoscopy; Device: fiber-optic bronchoscopy; Group 2 (hypoxemic patients who will undergo conventional bronchoscopy under conventional o2 therapy without NIV ) will be on conventional oxygen therapy half an hour prior and throughout the bronchoscopic sampling and after the procedure until reach the baseline criteria; Other Names: conventional oxygen therapy; conventional bronchoscopy under oxygen therapy; Device: non- invasive ventilator; Group 3 (non- hypoxemic patients who will undergo bronchoscopy under non- invasive ventilation{NIV} and conventional o2 therapy) will be on NIV throughout the bronchoscopic sampling and after the procedure until reach the baseline criteria; Other Names: conventional oxygen therapy; fiber-optic bronchoscopy; Device: fiber-optic bronchoscopy; Group 4 (non- hypoxemic patients who will undergo conventional bronchoscopy without non- invasive ventilation{NIV) will be on conventional oxygen therapy throughout the bronchoscopic sampling and after the procedure until reach the baseline criteria; Other Names: conventional oxygen therapy; conventional bronchoscopy under oxygen therapy
Active Comparator: (Group 2) 25 (H. conv.): Hypoxemic patients{hypoxemic conventional group }; who will undergo conventional fiber-optic bronchoscopy under conventional oxygen therapy without non- invasive ventilation	Device: fiber-optic bronchoscopy; Group 2 (hypoxemic patients who will undergo conventional bronchoscopy under conventional o2 therapy without NIV ) will be on conventional oxygen therapy half an hour prior and throughout the bronchoscopic sampling and after the procedure until reach the baseline criteria; Other Names: conventional oxygen therapy; conventional bronchoscopy under oxygen therapy; Device: fiber-optic bronchoscopy; Group 4 (non- hypoxemic patients who will undergo conventional bronchoscopy without non- invasive ventilation{NIV) will be on conventional oxygen therapy throughout the bronchoscopic sampling and after the procedure until reach the baseline criteria; Other Names: conventional oxygen therapy; conventional bronchoscopy under oxygen therapy
Active Comparator: (Group 3) 25 (N.H.NIV): Non- hypoxemic patients{non-hypoxemic NIV group}; who will undergo fiber-optic bronchoscopy under non- invasive ventilation and conventional oxygen therapy	Device: non- invasive ventilator; Group 1 (hypoexemic patient who will undergo bronchoscopy under non- invasive ventilation{NIV} and conventional o2 therapy) will be on NIV half an hour prior and throughout the bronchoscopic sampling and after the procedure until reach the baseline criteria; Other Names: conventional oxygen therapy; fiber-optic bronchoscopy; Device: fiber-optic bronchoscopy; Group 2 (hypoxemic patients who will undergo conventional bronchoscopy under conventional o2 therapy without NIV ) will be on conventional oxygen therapy half an hour prior and throughout the bronchoscopic sampling and after the procedure until reach the baseline criteria; Other Names: conventional oxygen therapy; conventional bronchoscopy under oxygen therapy; Device: non- invasive ventilator; Group 3 (non- hypoxemic patients who will undergo bronchoscopy under non- invasive ventilation{NIV} and conventional o2 therapy) will be on NIV throughout the bronchoscopic sampling and after the procedure until reach the baseline criteria; Other Names: conventional oxygen therapy; fiber-optic bronchoscopy; Device: fiber-optic bronchoscopy; Group 4 (non- hypoxemic patients who will undergo conventional bronchoscopy without non- invasive ventilation{NIV) will be on conventional oxygen therapy throughout the bronchoscopic sampling and after the procedure until reach the baseline criteria; Other Names: conventional oxygen therapy; conventional bronchoscopy under oxygen therapy
Active Comparator: (Group 4) 25(N.H. conv.): Non- hypoxemic patients{non-hypoxemic conventional group}; who will undergo conventional fiber-optic bronchoscopy under conventional oxygen therapy without non- invasive ventilation	Device: fiber-optic bronchoscopy; Group 2 (hypoxemic patients who will undergo conventional bronchoscopy under conventional o2 therapy without NIV ) will be on conventional oxygen therapy half an hour prior and throughout the bronchoscopic sampling and after the procedure until reach the baseline criteria; Other Names: conventional oxygen therapy; conventional bronchoscopy under oxygen therapy; Device: fiber-optic bronchoscopy; Group 4 (non- hypoxemic patients who will undergo conventional bronchoscopy without non- invasive ventilation{NIV) will be on conventional oxygen therapy throughout the bronchoscopic sampling and after the procedure until reach the baseline criteria; Other Names: conventional oxygen therapy; conventional bronchoscopy under oxygen therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the changes in oxygen saturation, heart rate, respiratory rate, blood pressure, dyspnea score and arterial blood gases in bronchoscopy procedure	Evaluate changes and when to reach base line in each of 1- (SPO2) by pulse oximeter in (percentage %) at base line, 15 minute before, during and immediately after bronchoscopy. 2-heart rate in (beat/minute) at base line, 15 minute before, during and immediately after bronchoscopy. 3-respiratory rate in (cycle/minute) at base line, 15 minute before, during and immediately after bronchoscopy. 4-mean arterial blood pressure in {millimeter/mercury mm/Hg)} at base line, 15 minute before, during and immediately after bronchoscopy. 5-dyspnea score in {grade 0-3 according to: (mMRC)} 15 minute before and immediately after bronchoscopy. arterial blood gases (PH, Paco2 in {millimeter/mercury (mm/Hg)}, Pao2 in {millimeter/mercury (mm/Hg)},Spo2 (percentage %) andHco3 in {millimol (mmol/l)} before and after bronchoscopy. To show effects of using NIV and conventional o2 therapy and using of conventional o2 therapy alone on these parameters in the studied patients in bronchoscopy.	4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fiber-optic bronchoscopy complications	The need for intubation, if it occurs within two to eight hours of bronchoscopy, it was considered as a complication possibly related to bronchoscopy. This time span was adopted from previous studies (Hilbertet et al., 2001). Also the existence of complications as hemorrhage, pneumothorax, hypotension, arrhythmia) that occurred during bronchoscopy and in the first 24 hours following bronchoscopy, which could possibly be related to the procedure (Schönhofer et al., 2008).	4 years

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Ahmed El sayed, MD, Mansoura University; Study Director: Amr Moawad, MD, Mansoura University; Study Director: Mohamed Mansour, MD, Mansoura University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2020
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: September 9, 2023
• First Submitted That Met QC Criteria: October 28, 2023
• First Posted (Actual): November 3, 2023

Study Record Updates

• Last Update Posted (Actual): May 11, 2025
• Last Update Submitted That Met QC Criteria: May 7, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: non- invasive ventilation; fiber-optic bronchoscopy.
• Other Study ID Numbers: Bronchoscopy with NIV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No