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Clinical Trials/NCT06115395
NCT06115395
Recruiting
Not Applicable

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

Mansoura University1 site in 1 country100 target enrollmentJuly 25, 2020
ConditionsLungDiseases

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung
Sponsor
Mansoura University
Enrollment
100
Locations
1
Primary Endpoint
Evaluation of the changes in oxygen saturation, heart rate, respiratory rate, blood pressure, dyspnea score and arterial blood gases in bronchoscopy procedure
Status
Recruiting
Last Updated
11 months ago

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.

Registry
clinicaltrials.gov
Start Date
July 25, 2020
End Date
December 31, 2025
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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

Mansoura University

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.

Outcomes

Primary Outcomes

Evaluation of the changes in oxygen saturation, heart rate, respiratory rate, blood pressure, dyspnea score and arterial blood gases in bronchoscopy procedure

Time Frame: 4 years

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.

Secondary Outcomes

  • Fiber-optic bronchoscopy complications(4 years)

Study Sites (1)

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