Three Different Oxygenation Strategies in Bronchoscopy Procedures Under Sedation

June 25, 2023 updated by: Süleyman Taş, Ankara City Hospital Bilkent

Comparison of Three Different Oxygenation Strategies Consisting of Nasal Cannula, Modified Nasopharyngeal Cannula and HFNO (High Flow Nasal Oxygen) in Bronchoscopy Procedures Under Sedation

The purpose of study aims to determine which of the three different oxygenation strategies, including nasal cannula, modified nasopharyngeal cannula, and HFNO groups, is safer in patients undergoing bronchoscopy under sedation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The patients will be evaluated in the anesthesia polyclinic before the procedure, routine preparation will be made, and written informed consent will be obtained. After being informed about the study and potential risks, all patients who gave written informed consent will be enrolled in the study by recording their demographic information after determining whether they are eligible to participate in the study. In addition, STOP-BANG and FRAIL fragility questionnaires will be administered to the patients. Which oxygenation method should be used which patient will be left to the decision of the Anesthesiologist; The oxygenation tools used in the bronchoscopy unit are nasal cannula, modified nasopharyngeal cannula, and HFNO. When the patients are taken to the procedure room, anesthesia management will be applied by the standard working order of the anesthesia clinic. In addition to non-invasive arterial blood pressure monitoring, 5-channel ECG and pulse oximetry, and standard hemodynamic monitoring, Bispectral Index (BIS) monitoring will be performed. During the process, oxygen saturation will be continuously monitored and the lowest value will be recorded. Interventions made in cases of low oxygen saturation will also be recorded. At the end of the procedure, the patient will be taken to the recovery unit after waking up.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
252

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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
    • Çankaya
      • Ankara, Çankaya, Turkey, 06800

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients admitted to the bronchoscopy unit for the procedure

Description

Inclusion Criteria:

  • All patients undergoing bronchoscopy

Exclusion Criteria:

  • Do not have the ability to read, understand and sign the consent form
  • Pregnancy
  • Contraindications to anesthetic drugs
  • Hemodynamically unstable patients
  • Having a peripheral vascular disease
  • Intubated patients
  • Patients with tracheostomy

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
nasal cannula group
Nasal cannula will be used in bronchoscopy procedures in which sedation is applied in this group.
Other: different oxygenation methods
Different oxygenation methods are used in bronchoscopy procedures under sedation.
modified nasopharyngeal cannula group
In this group, modified nasopharyngeal cannula will be used in bronchoscopy procedures with sedation.
Other: different oxygenation methods
Different oxygenation methods are used in bronchoscopy procedures under sedation.
HFNO group
HFNO will be used in bronchoscopy procedures in which sedation is applied in this group.
Other: different oxygenation methods
Different oxygenation methods are used in bronchoscopy procedures under sedation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
desaturation rate during processing
Time Frame: during the procedure, an average of 1 hour
desaturation: oxygen saturation falling below 90%. Oxygen saturation was monitored continuously with a pulse oximeter attached to one of the fingers. It was recorded when oxygen saturation dropped to < 90%.
during the procedure, an average of 1 hour

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
rate of use of the jaw thrust maneuver during the procedure
Time Frame: during the procedure, an average of 1 hour
The chin thrust maneuver is one of the maneuvers used to provide airway patency. The jaw thrust maneuvers performed by the anesthesiologist were recorded in patients who were desaturated during the procedure.
during the procedure, an average of 1 hour
rate of airway usage during the process
Time Frame: during the procedure, an average of 1 hour
The airway that was desaturated during the procedure and used by the anesthesiologist to ensure airway patency was recorded.
during the procedure, an average of 1 hour

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Desaturation rate in patients with a high risk of Osas according to the stop-bang score
Time Frame: before the procedure, 2 minutes
The stop-bang test can be used as a screening test for an osas. Scoring from 0 to 8 is given. 0-1-2 is low risk, 3-4 is medium risk, and 5-6-7-8 is high risk for Osas.
before the procedure, 2 minutes
Desaturation rate in patients with higher frailty scores than frail fragility scores
Time Frame: before the procedure, 2 minutes
The frail fragility test is one of the tests that measure the fragility of patients. Scoring from 0 to 5 is given. 0 is not frail, it is expressed as 1-2 prefrail and 3-4-5 frail.
before the procedure, 2 minutes

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara City Hospital Bilkent

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: süleyman taş, Ankara Bilkent City Hospital

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 28, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SuleymanTas1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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