Non-invasive Ventilation Assisted Fiber-optic Bronchoscopy

NCT ID: NCT06115395

Last Updated: 2025-05-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-25
• Study Completion Date: 2025-12-31

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.

Conditions

Lung; Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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

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

Group Type: ACTIVE_COMPARATOR

non- invasive ventilator

Intervention Type: 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

fiber-optic bronchoscopy

Intervention Type: 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

non- invasive ventilator

Intervention Type: DEVICE

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

fiber-optic bronchoscopy

Intervention Type: DEVICE

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

(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

Group Type: ACTIVE_COMPARATOR

fiber-optic bronchoscopy

Intervention Type: 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

fiber-optic bronchoscopy

Intervention Type: DEVICE

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

(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

Group Type: ACTIVE_COMPARATOR

non- invasive ventilator

Intervention Type: 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

fiber-optic bronchoscopy

Intervention Type: 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

non- invasive ventilator

Intervention Type: DEVICE

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

fiber-optic bronchoscopy

Intervention Type: DEVICE

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

(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

Group Type: ACTIVE_COMPARATOR

fiber-optic bronchoscopy

Intervention Type: 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

fiber-optic bronchoscopy

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DEVICE

Other Intervention Names

fiber-optic bronchoscopy; conventional oxygen therapy; conventional bronchoscopy under oxygen therapy; conventional oxygen therapy; fiber-optic bronchoscopy; conventional oxygen therapy; conventional bronchoscopy under oxygen therapy; conventional oxygen therapy

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Walaa Maher Abd El aziz

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed El sayed, MD

Role: STUDY_CHAIR

Mansoura University

Amr Moawad, MD

Role: STUDY_DIRECTOR

Mansoura University

Mohamed Mansour, MD

Role: STUDY_DIRECTOR

Mansoura University

Locations

Walaa Maher Abd ElAziz,

Al Mansurah, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Walaa Abd El Aziz, MD

Role: CONTACT

Wm22446699@gmail.com

01064904172

Mohamed Mansour, MD

Role: CONTACT

Mohammedmansour.md@gmail.com

01009400754

References

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.

Reference Type: BACKGROUND

Other Identifiers

Bronchoscopy with NIV

Identifier Type: -

Identifier Source: org_study_id