Three Different Oxygenation Strategies in Bronchoscopy Procedures Under Sedation

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: Recruiting
• Conditions: Bronchoscopy
• Intervention / Treatment: Other: different oxygenation methods

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: Observational
• Enrollment (Estimated): 252

Contacts and Locations

• Study Contact: Name: Süleyman Taş; Phone Number: +9005067846913; Email: tas_suleyman42@hotmail.com

Study Locations

• Turkey
  • Çankaya
    • Ankara, Çankaya, Turkey, 06800
      • Recruiting
      • Ankara Bilkent City Hospital
      • Contact: Süleyman Taş; Phone Number: +9005067846913; Email: tas_suleyman42@hotmail.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
desaturation rate during processing	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

Outcome Measure	Measure Description	Time Frame
rate of use of the jaw thrust maneuver during the procedure	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	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

Outcome Measure	Measure Description	Time Frame
Desaturation rate in patients with a high risk of Osas according to the stop-bang score	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	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

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Principal Investigator: süleyman taş, Ankara Bilkent City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2023
• Primary Completion (Estimated): September 1, 2023
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: June 11, 2023
• First Submitted That Met QC Criteria: June 11, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 25, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID 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