NCT05912985

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
252

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

June 27, 2023

Status Verified

June 1, 2023

Enrollment Period

5 months

First QC Date

June 11, 2023

Last Update Submit

June 25, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • rate of use of the jaw thrust maneuver during the procedure

    during the procedure, an average of 1 hour

  • rate of airway usage during the process

    during the procedure, an average of 1 hour

Other Outcomes (2)

  • Desaturation rate in patients with a high risk of Osas according to the stop-bang score

    before the procedure, 2 minutes

  • Desaturation rate in patients with higher frailty scores than frail fragility scores

    before the procedure, 2 minutes

Study Arms (3)

nasal cannula group

Nasal cannula will be used in bronchoscopy procedures in which sedation is applied in this group.

Other: different oxygenation methods

modified nasopharyngeal cannula group

In this group, modified nasopharyngeal cannula will be used in bronchoscopy procedures with sedation.

Other: different oxygenation methods

HFNO group

HFNO will be used in bronchoscopy procedures in which sedation is applied in this group.

Other: different oxygenation methods

Interventions

Different oxygenation methods are used in bronchoscopy procedures under sedation.

HFNO groupmodified nasopharyngeal cannula groupnasal cannula group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients admitted to the bronchoscopy unit for the procedure

You may qualify if:

  • All patients undergoing bronchoscopy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

RECRUITING

Study Officials

  • süleyman taş

    Ankara City Hospital Bilkent

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 11, 2023

First Posted

June 22, 2023

Study Start

March 28, 2023

Primary Completion

September 1, 2023

Study Completion

March 1, 2024

Last Updated

June 27, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations