NCT07760727

Brief Summary

This study aims to evaluate the effects of high-flow nasal oxygen therapy on respiratory complications, blood gas parameters, and post-procedural recovery in patients undergoing sedated endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). Participants will be assigned to receive either high-flow nasal oxygen therapy or conventional oxygen therapy during the procedure. The incidence of respiratory complications, blood gas changes, and recovery outcomes will be compared between the two groups.

Trial Health

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Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
3mo left

Started Aug 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 12, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

August 20, 2026

Expected
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2026

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2026

Last Updated

August 12, 2026

Status Verified

August 1, 2026

Enrollment Period

2 months

First QC Date

August 5, 2026

Last Update Submit

August 7, 2026

Conditions

Keywords

High flow oxygen therapy,Endobronchial Ultrasound-Transbronchial Needle Aspiration(EBUS-TBNA)SedationSedation ComplicationsBlood Gas Analysis

Outcome Measures

Primary Outcomes (1)

  • Respiratory Complications

    Incidence of respiratory complications during sedated EBUS-TBNA, including hypoxemia, oxygen desaturation, apnea, airway obstruction, and the need for airway interventions.

    During the procedure

Secondary Outcomes (5)

  • Oxygen partial pressure (PaO2)

    Baseline and within 15 minutes after completion of the endobronchial Ultrasound-Transbronchial Needle Aspiration (EBUS-TBNA) procedure

  • Carbon dioxide partial pressure (PvCO2)

    Baseline and within 15 minutes after completion of the EBUS-TBNA

  • Venous pH

    Baseline and within 15 minutes after completion of the EBUS-TBNA procedure.

  • Venous Oxygen Saturation (SvO2)

    Baseline and within 15 minutes after completion of the EBUS-TBNA procedure.

  • Recovry Time

    Up to 2 hours post-procedure

Study Arms (2)

Group H (High-Flow Nasal Oxygen Group)

Patients undergoing sedated EBUS-TBNA who receive high-flow nasal oxygen therapy during the procedure. Respiratory complications, oxygenation parameters, blood gas values, and post-procedural recovery outcomes are evaluated.

Device: High-Flow Nasal Oxygen Therapy

Group C (Conventional Oxygen Group)

Patients undergoing sedated EBUS-TBNA who receive conventional oxygen therapy during the procedure. Respiratory complications, oxygenation parameters, blood gas values, and post-procedural recovery outcomes are evaluated.

Device: Conventional Oxygen Therapy

Interventions

High-flow nasal oxygen therapy administered during sedated EBUS-TBNA procedures to provide enhanced oxygenation and respiratory support.

Group H (High-Flow Nasal Oxygen Group)

Conventional oxygen therapy administered during sedated EBUS-TBNA procedures using standard oxygen delivery methods

Group C (Conventional Oxygen Group)

Eligibility Criteria

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

Adult patients (≥18 years) scheduled to undergo sedated endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) at Ankara Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital. Participants will be allocated to receive either high-flow nasal oxygen therapy or conventional oxygen therapy during the procedure

You may qualify if:

  • Age ≥18 years. Scheduled to undergo sedated EBUS-TBNA. Ability to provide written informed consent. ASA physical status I-III.

You may not qualify if:

  • Age \<18 years.
  • Pregnancy.
  • Requirement for endotracheal intubation or general anesthesia.
  • Severe hemodynamic instability.
  • Refusal to participate in the study.
  • Contraindication to high-flow nasal oxygen therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Dr. Abdurrahman Yurtaslan Oncolgy Training and Research Hospital

Ankara, Central, 0620, Turkey (Türkiye)

Location

Related Publications (1)

  • Sampsonas F, Karamouzos V, Karampitsakos T, Papaioannou O, Katsaras M, Lagadinou M, Zarkadi E, Malakounidou E, Velissaris D, Stratakos G, Tzouvelekis A. High-Flow vs. Low-Flow Nasal Cannula in Reducing Hypoxemic Events During Bronchoscopic Procedures: A Systematic Review and Meta-Analysis. Front Med (Lausanne). 2022 Feb 24;9:815799. doi: 10.3389/fmed.2022.815799. eCollection 2022.

    PMID: 35280891BACKGROUND

Central Study Contacts

ÖZLEM KAPUSUZ KÖRDUMAN, MD

CONTACT

Güldeniz Argun, Prof

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiology and Reanimation Specialist

Study Record Dates

First Submitted

August 5, 2026

First Posted

August 12, 2026

Study Start (Estimated)

August 20, 2026

Primary Completion (Estimated)

October 20, 2026

Study Completion (Estimated)

November 20, 2026

Last Updated

August 12, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations