Non-invasive Ventilation Assisted Fiber-optic Bronchoscopy

NCT06115395 | Recruiting

• 1 other identifier: Bronchoscopy with NIV
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung; Diseases

Keywords

non- invasive ventilation; fiber-optic bronchoscopy.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Fiber-optic bronchoscopy complications

  4 years

Study Arms (4)

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

ACTIVE COMPARATOR

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

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

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

ACTIVE COMPARATOR

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

Device: fiber-optic bronchoscopy

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

ACTIVE COMPARATOR

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

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

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

ACTIVE COMPARATOR

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

Device: fiber-optic bronchoscopy

Interventions

non- invasive ventilator DEVICE

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

Also known as: fiber-optic bronchoscopy, conventional oxygen therapy

(Group 1) 25 (H. NIV): Hypoxemic patients{hypoxemic NIV group}; (Group 3) 25 (N.H.NIV): Non- hypoxemic patients{non-hypoxemic NIV group}

fiber-optic bronchoscopy DEVICE

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

Also known as: conventional bronchoscopy under oxygen therapy, conventional oxygen therapy

(Group 1) 25 (H. NIV): Hypoxemic patients{hypoxemic NIV group}; (Group 2) 25 (H. conv.): Hypoxemic patients{hypoxemic conventional group }; (Group 3) 25 (N.H.NIV): Non- hypoxemic patients{non-hypoxemic NIV group}; (Group 4) 25(N.H. conv.): Non- hypoxemic patients{non-hypoxemic conventional group}

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who admitted to the pulmonology ward or intensive care unit with any (diagnostic and/or therapeutic) bronchoscopy indication.
• Age 18 years or more.
• Patients accepted to participate in the study.

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Walaa Maher Abd ElAziz,

Al Mansurah, Egypt

RECRUITING

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ahmed El sayed, MD

  Mansoura University

  STUDY CHAIR

• Amr Moawad, MD

  Mansoura University

  STUDY DIRECTOR

• Mohamed Mansour, MD

  Mansoura University

  STUDY DIRECTOR

Central Study Contacts

Walaa Abd El Aziz, MD

CONTACT

01064904172; Wm22446699@gmail.com

Mohamed Mansour, MD

CONTACT

01009400754; Mohammedmansour.md@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Sample method: Method of randomization was stratified random sampling method was adopted to create matched study groups. Patients admitted for bronchoscopy were classified into two categories: 1. A) Non hypoxemic group. 2. B) Hypoxemic group. 3. From each category: 50 patients were selected and allocated randomly in the study groups (either intervention or control group) using lottery method. So, each study group with included 25 patients from each category forming a total of 50 patients in each studies categories.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Walaa Maher abd El aziz, Head of NIV Ahmed Younis El-sayed, Clinical Professor Amr Abd El-Hamid Moawad and Director Mohamed Ahmed Mansour Affiliation: Mansoura University

Study Record Dates

• First Submitted: September 9, 2023
• First Posted: November 3, 2023
• Study Start: July 25, 2020
• Primary Completion: December 30, 2025
• Study Completion: December 31, 2025
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)