HFNC During Bronchoscopy for Bronchoalveolar Lavage

NCT04016480 | Completed

• 1 other identifier: HFNC-FBS
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The execution of diagnostic-therapeutic investigations by bronchial endoscopy can expose the patient to acute respiratory failure (ARF). In particular, the risk of hypoxemia is greater during broncho-alveolar lavage (BAL). For this reason, oxygen therapy is administered at low or high flows during the course of bronchoscopic procedures, in order to avoid hypoxemia. Few clinical studies have demonstrated the efficacy and safety of high flow oxygen through nasal cannula (HFNC) during BAL procedures, and no study has evaluated, during bronchial endoscopy, the effects of HFNC on diaphragmatic effort (assessed with ultrasound) and aeration and ventilation of the different lung regions (assessed with electrical impedance tomography). Therefore, investigators conceived the present randomized controlled study to evaluate possible differences existing during bronchoscopy between oxygen therapy administered with HFNC and conventional (low-flow) oxygen therapy, delivered through nasal cannula.

Conditions

Acute Respiratory Failure; Bronchoscopy; Bronchoalveolar Lavage

Outcome Measures

Primary Outcomes (1)

• Arterial blood gases at end of the procedure

  Arterial blood will be sample for gas analysis

  After 0 minute from the end of the bronchial endoscopy

Secondary Outcomes (11)

• Respiratory effort at end of the procedure

  After 0 minute from the end of the bronchial endoscopy

• Respiratory effort at baseline

  After 0 minute from enrollment

• Respiratory effort at the beginning of the bronchoscopy

  5 minutes before the beginning of the bronchial endoscopy, while receiving the assigned treatment

• Respiratory effort after bronchoscopy

  After 10 minute from the end of the bronchial endoscopy

• Change of end-expiratory lung impedance (dEELI) from baseline at the beginning of the bronchoscopy

  5 minutes before the beginning of the bronchial endoscopy, while receiving the assigned treatment, compared to baseline

Study Arms (2)

High Flow Nasal Cannula

ACTIVE COMPARATOR

High Flow Nasal cannula is a system to deliver heated and humidified oxygen with an inspired oxygen fraction between 21 and 100% through large bore nasal cannula. The system delivers a flow up to 60 liters/min.

Device: High Flow Nasal Cannula

Conventional Oxygen Therapy

ACTIVE COMPARATOR

Conventional oxygen therapy will be administered through common nasal cannula with a flow up to 6 Liters per minute

Device: Conventional Oxygen Therapy

Interventions

High Flow Nasal Cannula DEVICE

High Flow Nasal Cannula will be set at 60 liters per minute of air/oxygen admixture to reach a peripheral oxygen saturation equal or greater than 94%

High Flow Nasal Cannula

Conventional Oxygen Therapy DEVICE

Conventional Oxygen Therapy will be administered through nasal cannula with a oxygen flow set to achieve a peripheral oxygen saturation equal or greater than 94%

Conventional Oxygen Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• need for bronchial endoscopy for bronchoalveolar lavage

You may not qualify if:

• life-threatening cardiac aritmia or acute miocardical infarction within 6 weeks
• need for invasive or non invasive ventilation
• presence of pneumothorax or pulmonary enphisema or bullae
• recent (within 1 week) thoracic surgery
• presence of chest burns
• presence of tracheostomy
• pregnancy
• nasal or nasopharyngeal diseases
• dementia
• lack of consent or its withdrawal

Sponsors & Collaborators

• University Magna Graecia: lead

Study Sites (1)

AOU Mater Domini

Catanzaro, Italy

Location

Related Publications (12)

• Albertini R, Harrel JH, Moser KM. Letter: Hypoxemia during fiberoptic bronchoscopy. Chest. 1974 Jan;65(1):117-8. doi: 10.1378/chest.65.1.117. No abstract available.

  PMID: 4809326 BACKGROUND

• Randazzo GP, Wilson AR. Cardiopulmonary changes during flexible fiberoptic bronchoscopy. Respiration. 1976;33(2):143-9. doi: 10.1159/000193727.

  PMID: 935677 BACKGROUND

• Pirozynski M, Sliwinski P, Radwan L, Zielinski J. Bronchoalveolar lavage: comparison of three commonly used procedures. Respiration. 1991;58(2):72-6. doi: 10.1159/000195900.

  PMID: 1862254 BACKGROUND

• Cuquemelle E, Pham T, Papon JF, Louis B, Danin PE, Brochard L. Heated and humidified high-flow oxygen therapy reduces discomfort during hypoxemic respiratory failure. Respir Care. 2012 Oct;57(10):1571-7. doi: 10.4187/respcare.01681. Epub 2012 Mar 12.

  PMID: 22417569 BACKGROUND

• Renda T, Corrado A, Iskandar G, Pelaia G, Abdalla K, Navalesi P. High-flow nasal oxygen therapy in intensive care and anaesthesia. Br J Anaesth. 2018 Jan;120(1):18-27. doi: 10.1016/j.bja.2017.11.010. Epub 2017 Nov 21.

  PMID: 29397127 BACKGROUND

• Matamis D, Soilemezi E, Tsagourias M, Akoumianaki E, Dimassi S, Boroli F, Richard JC, Brochard L. Sonographic evaluation of the diaphragm in critically ill patients. Technique and clinical applications. Intensive Care Med. 2013 May;39(5):801-10. doi: 10.1007/s00134-013-2823-1. Epub 2013 Jan 24.

  PMID: 23344830 BACKGROUND

• Zambon M, Greco M, Bocchino S, Cabrini L, Beccaria PF, Zangrillo A. Assessment of diaphragmatic dysfunction in the critically ill patient with ultrasound: a systematic review. Intensive Care Med. 2017 Jan;43(1):29-38. doi: 10.1007/s00134-016-4524-z. Epub 2016 Sep 12.

  PMID: 27620292 BACKGROUND

• Costa EL, Lima RG, Amato MB. Electrical impedance tomography. Curr Opin Crit Care. 2009 Feb;15(1):18-24. doi: 10.1097/mcc.0b013e3283220e8c.

  PMID: 19186406 BACKGROUND

• Miyagi K, Haranaga S, Higa F, Tateyama M, Fujita J. Implementation of bronchoalveolar lavage using a high-flow nasal cannula in five cases of acute respiratory failure. Respir Investig. 2014 Sep;52(5):310-4. doi: 10.1016/j.resinv.2014.06.006. Epub 2014 Jul 25.

  PMID: 25169847 BACKGROUND

• Kim EJ, Jung CY, Kim KC. Effectiveness and Safety of High-Flow Nasal Cannula Oxygen Delivery during Bronchoalveolar Lavage in Acute Respiratory Failure Patients. Tuberc Respir Dis (Seoul). 2018 Oct;81(4):319-329. doi: 10.4046/trd.2017.0122. Epub 2018 Jun 19.

  PMID: 29926546 BACKGROUND

• Longhini F, Pisani L, Lungu R, Comellini V, Bruni A, Garofalo E, Laura Vega M, Cammarota G, Nava S, Navalesi P. High-Flow Oxygen Therapy After Noninvasive Ventilation Interruption in Patients Recovering From Hypercapnic Acute Respiratory Failure: A Physiological Crossover Trial. Crit Care Med. 2019 Jun;47(6):e506-e511. doi: 10.1097/CCM.0000000000003740.

  PMID: 30882477 BACKGROUND

• Longhini F, Pelaia C, Garofalo E, Bruni A, Placida R, Iaquinta C, Arrighi E, Perri G, Procopio G, Cancelliere A, Rovida S, Marrazzo G, Pelaia G, Navalesi P. High-flow nasal cannula oxygen therapy for outpatients undergoing flexible bronchoscopy: a randomised controlled trial. Thorax. 2022 Jan;77(1):58-64. doi: 10.1136/thoraxjnl-2021-217116. Epub 2021 Apr 29.

  PMID: 33927023 DERIVED

Study Officials

• Federico Longhini, MD

  Magna Graecia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 11, 2019
• Study Start: September 12, 2019
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: December 4, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be shared after results publication of indexed journal in english language
• Access Criteria: On reasonable request

Locations

IT (1)