NCT04686656

Brief Summary

The purpose of this study is to compare to nasal and buccal oxygen administration in patients undergoing Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 23, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

December 24, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 29, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2021

Completed
Last Updated

April 8, 2021

Status Verified

December 1, 2020

Enrollment Period

2 months

First QC Date

December 23, 2020

Last Update Submit

April 6, 2021

Conditions

Lung Diseases

Outcome Measures

Primary Outcomes (1)

  • hypoxia-related interruptions

    the number of hypoxia-related interruptions

    30 minutes

Secondary Outcomes (4)

  • duration of procedure

    30 minutes

  • use of propofol

    30 minutes

  • use of fentanyl

    30 minutes

  • satisfaction of pulmonary specialist

    30 minutes

Study Arms (2)

nasal oxygen supplementation group

ACTIVE COMPARATOR

supplemental oxygen will be administered with nasal cannula

Other: nasal oxygen

buccal oxygen supplementation group

ACTIVE COMPARATOR

supplemental oxygen will be administered with Ring-Adair-Elwyn (RAE) tube

Other: buccal oxygen

Interventions

nasal oxygenOTHER

Nasal cannula will be placed by the anesthesiologist. 6 l/ min of supplemental oxygen will be administered with nasal cannula.

nasal oxygen supplementation group
buccal oxygenOTHER

Ring-adair-elwyn (RAE) tube will be placed by the anesthesiologist. 6 l/ min of supplemental oxygen will be administered with RAE tube.

buccal oxygen supplementation group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients ≥18 years of age
  • body mass index (BMI) between 20 and 30
  • American Society of Anesthesiologists physical status I-III

You may not qualify if:

  • congestive heart failure
  • ischemic heart disease
  • increased intracranial pressure
  • known allergy or contraindication to study drugs (propofol, fentanyl, or midazolam)
  • an anatomical feature precluding adequate positioning of the buccal device.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antalya Training and Researching Hospital

Antalya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • tayfun sugur, MD

    Antalya Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2020

First Posted

December 29, 2020

Study Start

December 24, 2020

Primary Completion

February 24, 2021

Study Completion

April 6, 2021

Last Updated

April 8, 2021

Record last verified: 2020-12

Locations

TU(1)