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Completed

NCT Number: NCT03226964

Assessment of High Flow Nasal Cannula Oxygenation in EBUS Bronchoscopy

This study is a prospective randomised trial where a computer will randomly allocate

patients to one of two possible methods of delivering oxygen during the procedure of

bronchoscopy. This trial compares high flow nasal cannula (HFNC) with nasal prongs in

delivering oxygen to patients undergoing endo-bronchial ultrasound guided trans-

bronchial nodal aspiration (EBUS-TBNA) a specialised form of bronchoscopy procedure.

HFNC uses humidified higher gas flow rates than conventional low flow systems such as

nasal prongs which are limited by the respiratory rate and effort.

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Key information

Conditions

Lung Cancer Hemic and Lymphatic Diseases Lung Diseases Lung Neoplasms Lymphadenopathy Lymphatic Diseases Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Galway

Galway, Ireland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects with a peripheral arterial pulse oximetry ≥ 90% breathing room air
  • Age ≥ 18 years
  • Able to breathe spontaneously throughout the procedure

Exclusion criteria

  • Respiratory or cardiac failure
  • Recent myocardial infarction < 6 weeks ago
  • On long term oxygen therapy, those with tracheostomy and/ or non-invasive or invasive mechanical ventilation
  • Nasal and/ or nasopharyngeal disease
  • Inability to give informed consent
  • Dementia
  • Hepatic or end stage renal disease
  • Pregnancy

Treatment and study plan

high flow nasal oxygen

Device

humidified high flow nasal oxygen

Primary outcomes

  1. drop in oxygen saturation during procedure

    Time frame: through procedure completion defined as withdrawing scope from patient's mouth, an average of 30 minutes

    the difference in oxygen saturation levels between pre-treatment assessments and the lowest saturation level achieved during treatment

Secondary outcomes

  1. change in venous CO2

    Time frame: 1 hour after procedure

    Change in venous CO2 1 hour after procedure compared to pre-procedure level

  2. end tidal CO2 during procedure

    Time frame: through procedure completion defined as withdrawing scope from patient's mouth an average of 30 minutes

    Measured with tip of scope at lower trachea

  3. Patient experience measure on a visual analogue scale

    Time frame: up to 3 hours after procedure

  4. endotracheal intubation during or post procedure

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

University College Hospital Galway

Other

Registry information

Acronym: AHOE

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 24, 2017
Registry last updated
May 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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