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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
300
nasal cannula
High flow nasal cannula
Bronchoscopy suite, PGIMER
Chandigarh, India
Bronchoscopy suite
Chandigarh, India
proportion of subjects experiencing oxygen desaturation events
oxygen desaturation events (defined SpO2 \<90% for at least 10 seconds) during the EBUS-TBNA procedure
Time frame: 1 hour (during the EBUS procedure)
SPO2 after pre-oxygenation
Pre-oxygenation for 5 minutes before sedation
Time frame: 1 hour (during the EBUS procedure)
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
Time frame: 1 hour (during the EBUS procedure)
nadir SPO2 level during the procedure
lowest oxygen saturation
Time frame: 1 hour (during the EBUS procedure)
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
Time frame: 1 hour (during the EBUS procedure)
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
Time frame: 1 hour (during the EBUS procedure)
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