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NCT Number: NCT06115395

Non-invasive Ventilation Assisted Fiber-optic Bronchoscopy

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.

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Walaa Maher Abd ElAziz,

Al Mansurah, Egypt

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: fiber-optic bronchoscopy, conventional oxygen therapy

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

Other names: conventional bronchoscopy under oxygen therapy, conventional oxygen therapy

Primary outcomes

  1. 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

  1. Fiber-optic bronchoscopy complications

    Time frame: 4 years

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed Mansour, MD

CONTACT

[email protected]

01009400754

Walaa Abd El Aziz, MD

CONTACT

[email protected]

01064904172

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Nov 3, 2023
Registry last updated
May 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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