Three Different Oxygenation Strategies in Bronchoscopy Procedures Under Sedation

Bronchoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05912985
• Other study ID #: SuleymanTas1
• Status: Recruiting
• Start date: March 28, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: June 2023
• Source: Ankara City Hospital Bilkent
• Contact: süleyman tas
• Phone: +9005067846913
• Email: tas_suleyman42[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 252
• Est. completion date: March 1, 2024
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bronchoscopy

Intervention

Other:
• different oxygenation methods
Different oxygenation methods are used in bronchoscopy procedures under sedation.

Locations

Country	Name	City	State
Turkey	Ankara Bilkent City Hospital	Ankara	Çankaya

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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
Secondary	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