Clinical trial NCT05425836: HFNC Versus SOT During 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endobronchial Ultrasound
Lead sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arm parallel group
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: proportion of subjects experiencing oxygen desaturation events
timeFrame: 1 hour (during the EBUS procedure)
Secondary outcomes:
measure: SPO2 after pre-oxygenation
timeFrame: 1 hour (during the EBUS procedure)
measure: number of desaturation events (SPO2 <90% for at least 10 seconds) during the procedure
timeFrame: 1 hour (during the EBUS procedure)
measure: nadir SPO2 level during the procedure
timeFrame: 1 hour (during the EBUS procedure)
measure: patient comfort and bronchoscopist satisfaction score
timeFrame: 1 hour (during the EBUS procedure)
measure: number of participants experiencing complications in each group
timeFrame: 1 hour (during the EBUS procedure)
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Bronchoscopy suite, PGIMER
city: Chandigarh
country: India
facility: Bronchoscopy suite
Study officials:
References: