Non-invasive Ventilation Assisted Fiber-optic Bronchoscopy

Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06115395
• Other study ID #: Bronchoscopy with NIV
• Status: Recruiting
• Phase: N/A
• Start date: July 25, 2020
• Est. completion date: October 30, 2025

Study information

• Verified date: September 2023
• Source: Mansoura University
• Contact: Walaa Abd El Aziz, MD
• Phone: 01064904172
• Email: Wm22446699[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diseases
• Lung

Intervention

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
• 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
• 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
• 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

Locations

Country	Name	City	State
Egypt	Walaa Maher Abd ElAziz,	El Mansura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

References & 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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