Effects of Different Ventilatory Strategy During Bronchoscopy

July 13, 2023 updated by: Liya Lu, The First Affiliated Hospital of Guangzhou Medical University

The execution of diagnostic-therapeutic investigations by bronchial endoscopy can expose the patient to hypoxemia. For this reason, oxygen therapy is administered at low or high flows during the course of bronchoscopic procedures.

Our study aim was to evaluate the efficacy and complications of High-flow nasal oxygen (HFNO) via Supraglottic jet oxygenation and ventilation (SJOV)during flexible bronchoscopy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • need for bronchial endoscopy

Exclusion Criteria:

  • life-threatening cardiac aritmia or acute miocardical infarction within 6 weeks need for invasive or non invasive ventilation presence of pneumothorax or pulmonary enphisema or bullae recent (within 1 week) thoracic surgery presence of chest burns presence of tracheostomy pregnancy nasal or nasopharyngeal diseases dementia lack of consent or its withdrawal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group I
Conventional Oxygen Therapy
Device: Conventional Oxygen Therapy
Conventional Oxygen Therapy will be administered through Nasal catheter
Experimental: Group II
High-flow nasal oxygen
Device: High-flow nasal oxygen
High Flow Nasal Cannula will be administered
Experimental: Group III
Supraglottic jet oxygenation and ventilation
Device: Supraglottic jet oxygenation and ventilation
Nasal jet tube will be administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the intraoperative oxygenation.
Time Frame: During bronchoscopy, an average of 0.5 hour.
The study will monitor the SpO2， heart rate(HR) and mean arterial pressure (MAP) during the procedure.
During bronchoscopy, an average of 0.5 hour.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arterial blood gases
Time Frame: At end of of bronchoscopy,an average of 0.5 hour after bronchoscope insertion.
Arterial blood gas analysis will be monitored at end of of procedure.
At end of of bronchoscopy,an average of 0.5 hour after bronchoscope insertion.
Assess the regional ventilation distribution by Electrical impedance tomography .
Time Frame: During bronchoscopy, an average of 0.5 hour.
Measurements will be done after bronchoscope insertion and at the end of the procedure.
During bronchoscopy, an average of 0.5 hour.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Guangzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 20, 2023

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

July 6, 2023

First Submitted That Met QC Criteria

July 13, 2023

First Posted (Actual)

July 21, 2023

Study Record Updates

Last Update Posted (Actual)

July 21, 2023

Last Update Submitted That Met QC Criteria

July 13, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 20230618

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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