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LungNCT06115395

Non-invasive Ventilation Assisted Fiber-optic Bronchoscopy

A study testing non- invasive ventilator and fiber-optic bronchoscopy in people with Lung and Diseases, run by Mansoura University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Lung, Diseases
What is being tested?
non- invasive ventilator and fiber-optic bronchoscopy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteEgypt
Study dates
25 Jul 2020to 31 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Patients with:
  • Cardiac or respiratory arrest.
  • Impaired consciousness or confusion.
  • Type II respiratory failure.
  • Hemodynamic instability.
  • Inability to cooperate or to protect the airway.
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Walaa Abd El Aziz, MD contact

01064904172

Wm22446699@gmail.com

Mohamed Mansour, MD contact

01009400754

Mohammedmansour.md@gmail.com

Egypt1 site, 1 recruiting

  • Walaa Maher Abd ElAziz,

    Al Mansurah

    Recruiting

Other trials in Egypt

About this study

Official title: Efficacy and Safety of Using 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.

Read the 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.

Conditions
Lung, Diseases
Being tested
non- invasive ventilator, fiber-optic bronchoscopy
Keywords
non- invasive ventilation, fiber-optic bronchoscopy.
Medical subject headings
Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • non- invasive ventilatorDevice

    Also called fiber-optic bronchoscopy, conventional oxygen therapy

    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 bronchoscopyDevice

    Also called conventional bronchoscopy under oxygen therapy, conventional oxygen therapy

    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 ventilatorDevice

    Also called fiber-optic bronchoscopy, conventional oxygen therapy

    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 bronchoscopyDevice

    Also called conventional bronchoscopy under oxygen therapy, conventional oxygen therapy

    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

Study groups in NCT06115395
Study groupRoleWhat they receive
(Group 1) 25 (H. NIV): Hypoxemic patients{hypoxemic NIV group}Active comparatorwho will undergo fiber-optic bronchoscopy under non- invasive ventilation and conventional oxygen therapy
Receives: Device: non- invasive ventilator; Device: fiber-optic bronchoscopy
(Group 2) 25 (H. conv.): Hypoxemic patients{hypoxemic conventional group }Active comparatorwho will undergo conventional fiber-optic bronchoscopy under conventional oxygen therapy without non- invasive ventilation
Receives: Device: fiber-optic bronchoscopy
(Group 3) 25 (N.H.NIV): Non- hypoxemic patients{non-hypoxemic NIV group}Active comparatorwho will undergo fiber-optic bronchoscopy under non- invasive ventilation and conventional oxygen therapy
Receives: Device: non- invasive ventilator; Device: fiber-optic bronchoscopy
(Group 4) 25(N.H. conv.): Non- hypoxemic patients{non-hypoxemic conventional group}Active comparatorwho will undergo conventional fiber-optic bronchoscopy under conventional oxygen therapy without non- invasive ventilation
Receives: Device: fiber-optic bronchoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 4 years

Secondary outcomes (1)

  1. 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).

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2023
  2. Study start25 Jul 2020
  3. Primary completion30 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06115395
Sponsor's protocol ID
Bronchoscopy with NIV
Status last verified
May 2025
First submitted
9 Sep 2023
Last updated
11 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing non- invasive ventilator and fiber-optic bronchoscopy in people with Lung and Diseases, run by Mansoura University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Walaa Abd El Aziz, MD (01064904172, Wm22446699@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06115395, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.

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