Microstream® Capnography in Endobronchial Ultrasonography Applications Under Sedation

NCT05696860 | Unknown

• 1 other identifier: BUU2019/8-18
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: Researchers wanted to investigate the effect of capnography monitoring in addition to routine monitoring on the development of desaturation and other vital parameters in endobronchial ultrasonography (EBUS) cases. Method: 100 patients who underwent EBUS under sedation will be included in this prospective and randomized controlled study. The cases will be divided into two groups of 50 people each. In the first group, standard monitoring will be performed, and in the second group, in addition to standard monitoring, capnography monitoring will be used. Heart rate, blood pressure, peripheral oxygen saturation (SpO2) values in both groups, end-tidal carbon dioxide (EtCO2), respiratory rate and integrated pulmonary index (IPI) values in the second group will be recorded in all cases. Disturbances in vital parameters and airway interventions, which were common in both groups, will ve compared. The frequency of problems detected by capnography monitoring in the second group will be examined.

Conditions

Capnography; Endobronchial Ultrasound

Outcome Measures

Primary Outcomes (1)

• Desaturation Development - Peripheric oxygen saturation decrease less than 90% on Pulse Oximetry

  Compare Experimental and Control Groups in Terms of Desaturation Development

  During Sedation, an average of 1 hour

Study Arms (2)

Monitorization with Capnography

EXPERIMENTAL

Patients followed with capnography and standard monitorization

Device: Capnography Monitoring

Monitorization Without Capnography

NO INTERVENTION

Patients followed with standard monitorization

Interventions

Capnography Monitoring DEVICE

Capnography monitoring

Monitorization with Capnography

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) score of 1-3,
• No pregnancy or suspected pregnancy
• No allergy history
• Signed informed consent

You may not qualify if:

• Emergency EBUS cases
• ASA score of 4
• Allergy or pregnancy history

Sponsors & Collaborators

• Uludag University: lead

Study Sites (1)

Bursa Uludag University Department of Anesthesiology and Reanimation

Bursa, Turkey (Türkiye)

Location

Study Officials

• Fatma Nur Kaya

  Supervisor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 26, 2022
• First Posted: January 25, 2023
• Study Start: May 8, 2019
• Primary Completion: February 1, 2023
• Study Completion: February 28, 2023
• Last Updated: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)