HFNC Versus SOT During EBUS

Endobronchial Ultrasound Clinical Trial

— NOT-EBUS  

Official title:

A Randomized Controlled Trial to Compare High Flow Nasal Cannula With Standard Nasal Cannula to Prevent Desaturation in Subjects Undergoing Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS-TBNA)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05425836
• Other study ID #: INT/IEC/2021/SPL-1049
• Status: Recruiting
• Phase: N/A
• Start date: June 10, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: June 2022
• Source: Postgraduate Institute of Medical Education and Research
• Contact: Inderpaul S Sehgal, MD, DM
• Phone: 91-172275
• Email: inderpgi[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Endobronchial ultrasound (EBUS)-guided transbronchial needle aspiration (TBNA) is a routine procedure that is performed to sample mediastinal lymph nodes. The procedure is performed either under conscious sedation or using general anaesthesia. At author's center the EBUS-TBNA procedure is performed under conscious sedation using midazolam.During the EBUS procedure, oxygen supplementation is provided to prevent desaturation events. However, despite oxygen supplementation previous studies have reported fall in pulse oximetric saturation (SpO2) below 90%.

The high-flow nasal cannula (HFNC) is a novel device for providing oxygen supplementation. It delivers a flow of 10-70 litres/min of humidified, warmed 100% oxygen through a nasal cannula. The device has been used extensively in intensive care setting in adults with hypoxemic respiratory failure. In a study conducted on patients undergoing EBUS-TBNA, the use of HFNC led to a significant reduction in the number of subjects experiencing clinically significant hypoxemia (SpO2 ≤90%) compared to conventional oxygen supplementation. However, the study conclusions were limited by a small sample size. Another study demonstrated lesser episodes of hypoxemia with HFNC compared to the conventional oxygen supplementation. This study also had a small sample size (n=40). The investigators that the use of 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 intend to assess the efficacy of HFNC in reducing the incidence of hypoxemic events in subjects undergoing EBUS under conscious sedation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: June 30, 2023
• Est. primary completion date: June 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. 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

Exclusion Criteria:

1. oxygen supplementation required to achieve SPO2 >95%;

2. subjects who have altered mentation;

3. pregnancy

4. failure to provide informed consent

Related Conditions & MeSH terms

• Endobronchial Ultrasound

Intervention

Device:
• Standard oxygen therapy
nasal cannula
• HFNC
High flow nasal cannula

Locations

Country	Name	City	State
India	Bronchoscopy suite	Chandigarh
India	Bronchoscopy suite, PGIMER	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	SPO2 after pre-oxygenation	Pre-oxygenation for 5 minutes before sedation	1 hour (during the EBUS procedure)
Secondary	number of desaturation events (SPO2 <90% for at least 10 seconds) during the procedure	Desaturation events will defined as SPO2 <90% for at least 10 seconds	1 hour (during the EBUS procedure)
Secondary	nadir SPO2 level during the procedure	lowest oxygen saturation	1 hour (during the EBUS procedure)
Secondary	patient comfort and bronchoscopist satisfaction score	assessed on a visual analogue scale (VAS); VAS will be measured on a scale of 0 to 100 mm, 0 being very comfortable or satisfied and 100 being extremely uncomfortable or unsatisfied	1 hour (during the EBUS procedure)
Secondary	number of participants experiencing complications in each group	cardiac arrhythmia, hypotension, escalation of the level of care (hospitalization, airway intubation need for non-invasive or invasive mechanical ventilation), altered mentation, respiratory failure or cardiac arrest	1 hour (during the EBUS procedure)