Non-invasive Ventilation Assisted Fiber-optic Bronchoscopy

Study Overview
=================
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.

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

Conditions
-----------------
Lung, Diseases

Intervention / Treatment
-----------------
* Device: non- invasive ventilator
* Device: fiber-optic bronchoscopy
* Device: non- invasive ventilator
* Device: fiber-optic bronchoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: (Group 1) 25 (H. NIV): Hypoxemic patients{hypoxemic NIV group}<br>who will undergo fiber-optic bronchoscopy under non- invasive ventilation and conventional oxygen therapy | Device: non- invasive ventilator<br>* 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<br>* Other names: conventional oxygen therapy;Device: fiber-optic bronchoscopy<br>* 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<br>* Other names: conventional oxygen therapy;Device: non- invasive ventilator<br>* 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<br>* Other names: conventional oxygen therapy;Device: fiber-optic bronchoscopy<br>* 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<br>* Other names: conventional oxygen therapy;|
| Active Comparator: (Group 2) 25 (H. conv.): Hypoxemic patients{hypoxemic conventional group }<br>who will undergo conventional fiber-optic bronchoscopy under conventional oxygen therapy without non- invasive ventilation | Device: fiber-optic bronchoscopy<br>* 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<br>* Other names: conventional oxygen therapy;Device: fiber-optic bronchoscopy<br>* 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<br>* Other names: conventional oxygen therapy;|
| Active Comparator: (Group 3) 25 (N.H.NIV): Non- hypoxemic patients{non-hypoxemic NIV group}<br>who will undergo fiber-optic bronchoscopy under non- invasive ventilation and conventional oxygen therapy | Device: non- invasive ventilator<br>* 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<br>* Other names: conventional oxygen therapy;Device: fiber-optic bronchoscopy<br>* 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<br>* Other names: conventional oxygen therapy;Device: non- invasive ventilator<br>* 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<br>* Other names: conventional oxygen therapy;Device: fiber-optic bronchoscopy<br>* 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<br>* Other names: conventional oxygen therapy;|
| Active Comparator: (Group 4) 25(N.H. conv.): Non- hypoxemic patients{non-hypoxemic conventional group}<br>who will undergo conventional fiber-optic bronchoscopy under conventional oxygen therapy without non- invasive ventilation | Device: fiber-optic bronchoscopy<br>* 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<br>* Other names: conventional oxygen therapy;Device: fiber-optic bronchoscopy<br>* 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<br>* Other names: conventional 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
non- invasive ventilation, fiber-optic bronchoscopy.