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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (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 |
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| (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 |
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| (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 |
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| (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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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). |
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Inclusion Criteria:
Patients who admitted to the pulmonology ward or intensive care unit with any (diagnostic and/or therapeutic) bronchoscopy indication.
Exclusion Criteria:
Patients with:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Walaa Abd El Aziz, MD | Contact | 01064904172 | Wm22446699@gmail.com | |
| Mohamed Mansour, MD | Contact | 01009400754 | Mohammedmansour.md@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed El sayed, MD | Mansoura University | Study Chair |
| Amr Moawad, MD | Mansoura University | Study Director |
| Mohamed Mansour, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walaa Maher Abd ElAziz, | Recruiting | Al Mansurah | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 AnestesiologÃa. 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. |
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| ID | Term |
|---|---|
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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:
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| 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 |
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| non- invasive ventilator | 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 |
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| fiber-optic bronchoscopy | 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 |
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| 4 years |
| Mansoura University |
| Study Director |