HFNC Versus SOT During EBUS

NCT05425836 | Completed DMC

• 1 other identifier: INT/IEC/2021/SPL-1049
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

Endobronchial ultrasound (EBUS)-guided transbronchial needle aspiration (TBNA) is a routine procedure that is performed to sample mediastinal lymph nodes. At author's center the EBUS-TBNA procedure is performed under conscious sedation using midazolam. During the EBUS procedure, oxygen supplementation can either be provided using low flow or high flow through a nasal cannula. The investigators hypothesize that the use of high flow nasal cannula (HFNC) for oxygen supplementation during EBUS would be associated with lesser incidence of clinically significant hypoxemia (SpO2 ≤90%) when compared to conventional nasal cannula. In this study, the authors plan to assess the efficacy of HFNC in reducing the incidence of hypoxemic events in subjects undergoing EBUS under conscious sedation.

Conditions

Endobronchial Ultrasound

Outcome Measures

Primary Outcomes (1)

• proportion of subjects experiencing oxygen desaturation events

  oxygen desaturation events (defined SpO2 \<90% for at least 10 seconds) during the EBUS-TBNA procedure

  1 hour (during the EBUS procedure)

Secondary Outcomes (5)

• SPO2 after pre-oxygenation

  1 hour (during the EBUS procedure)

• number of desaturation events (SPO2 <90% for at least 10 seconds) during the procedure

  1 hour (during the EBUS procedure)

• nadir SPO2 level during the procedure

  1 hour (during the EBUS procedure)

• patient comfort and bronchoscopist satisfaction score

  1 hour (during the EBUS procedure)

• number of participants experiencing complications in each group

  1 hour (during the EBUS procedure)

Study Arms (2)

Oxygen supplementation in the conventional arm

ACTIVE COMPARATOR

will be delivered by nasal cannula. At 5 minutes prior to sedation the flow rate would be kept a 5 L/minute.; The flow will be increased to 6-8 L/minute to maintain SPO2 ≥92% during the procedure, up to a maximum of 15 L/minute, depending on the patient tolerance.

Device: Standard oxygen therapy

Oxygen supplementation in HFNC arm

EXPERIMENTAL

HFNC (OptiFlowTM; Fisher \& Paykel, Auckland, New Zealand) will be started 5 minutes before the sedation at a flow rate of 30 Litres/minute and at a fraction of inspired oxygen (FiO2) of 0.30, which will be titrated by increments of 10 liters/minute depending on oxygen demand to keep SPO2 ≥92% during the procedure. The flow rate will be maintained between 30- and 70-liters minute, depending on the patient tolerance.

Device: HFNC

Interventions

Standard oxygen therapy DEVICE

nasal cannula

Oxygen supplementation in the conventional arm

HFNC DEVICE

High flow nasal cannula

Oxygen supplementation in HFNC arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. All adult (aged between 18 and 80 years) subjects undergoing the EBUS-TBNA procedure and pulse oximetric SPO2 ≥95% at room air will be eligible for this study

You may not qualify if:

• oxygen supplementation required to achieve SPO2 \>95%;
• subjects who have altered mentation;
• pregnancy
• failure to provide informed consent

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (2)

Bronchoscopy suite, PGIMER

Chandigarh, 160012, India

Location

Bronchoscopy suite

Chandigarh, 160012, India

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Two arm parallel group

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 21, 2022
• Study Start: June 10, 2022
• Primary Completion: December 31, 2023
• Study Completion: January 31, 2024
• Last Updated: August 14, 2024

Record last verified: 2024-08

Locations

IN (2)