Endobronchial Ultrasound
Conditions
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.
Interventions
DEVICEStandard oxygen therapy
nasal cannula
DEVICEHFNC
High flow nasal cannula
Sponsors
Post Graduate Institute of Medical Education and Research, Chandigarh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Two arm parallel group
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| proportion of subjects experiencing oxygen desaturation events | 1 hour (during the EBUS procedure) | oxygen desaturation events (defined SpO2 \<90% for at least 10 seconds) during the EBUS-TBNA procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SPO2 after pre-oxygenation | 1 hour (during the EBUS procedure) | Pre-oxygenation for 5 minutes before sedation |
| number of desaturation events (SPO2 <90% for at least 10 seconds) during the procedure | 1 hour (during the EBUS procedure) | Desaturation events will defined as SPO2 \<90% for at least 10 seconds |
| nadir SPO2 level during the procedure | 1 hour (during the EBUS procedure) | lowest oxygen saturation |
| patient comfort and bronchoscopist satisfaction score | 1 hour (during the EBUS procedure) | 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 |
| number of participants experiencing complications in each group | 1 hour (during the EBUS procedure) | 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 |
Countries
India
Outcome results
None listed