HFNC Versus SOT During EBUS (NOT-EBUS)

Post Graduate Institute of Medical Education and Research, Chandigarh

Status: Completed

Conditions: Endobronchial Ultrasound

Treatments: Device: HFNC; Device: Standard oxygen therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05425836

INT/IEC/2021/SPL-1049

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Oxygen supplementation in the conventional arm

Active Comparator group

Description:

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.

Treatment:

Device: Standard oxygen therapy

Oxygen supplementation in HFNC arm

Experimental group

Description:

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.

Treatment:

Device: HFNC