HFNC Versus SOT During EBUS

NCT ID: NCT05425836

Last Updated: 2024-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-10
• Study Completion Date: 2024-01-31

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.

Conditions

Endobronchial Ultrasound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Oxygen supplementation in the conventional arm

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.

Group Type: ACTIVE_COMPARATOR

Standard oxygen therapy

Intervention Type: DEVICE

nasal cannula

Oxygen supplementation in HFNC arm

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.

Group Type: EXPERIMENTAL

HFNC

Intervention Type: DEVICE

High flow nasal cannula

Interventions

Standard oxygen therapy

nasal cannula

Intervention Type: DEVICE

HFNC

High flow nasal cannula

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role: lead

Responsible Party

Inderpaul singh

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bronchoscopy suite, PGIMER

Chandigarh, , India

Bronchoscopy suite

Chandigarh, , India

Countries

India

Other Identifiers

INT/IEC/2021/SPL-1049

Identifier Type: -

Identifier Source: org_study_id