Skip to main content
OpenTrials
Completed

NCT Number: NCT03894072

HFHO vs CPAP During Thoracic Surgery

A single institutional cross-over study design to compare between high flow humidified oxygen (HFHO) device versus conventional CPAP for non-ventilated lung during thoracic surgery.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital

Bangkok, 10700, Thailand

About this study

The investigators hypothesize that HFHO may be an alternative tool to supply oxygen to non-ventilated lung during one lung ventilation. CPAP can improve oxygenation at a cost of lung hyperinflation which is an unwanted condition during thoracic surgery especially the video-assisted one.

Recruiting adult patients who undergo lung surgeries that requires one-lung ventilation. Exclusion criteria include the followings:-

  • Emergency case.
  • Patients with severe COPD(Chronic Obstructive Pulmonary Diseases).
  • Patients with moderate baseline hypoxemia (SpO2 < 90% on room air).
  • Patients with severe hemoptysis.
  • Patients with upper or lower airway abnormalities.
  • Patients undergo pulmonary lavage.
  • Patients with known pulmonary hypertension.
  • Patients with known pulmonary/tracheobronchial infections.
  • Patients with suspected difficult airway.
  • Patients with BMI over 35.
  • Pregnant patients.

Following a standard anesthetic practice. All participants will receive an intravenous based anesthetic with or without regional blocks. The appropriate sized double lumen endobronchial tube will be placed and fiberoptic bronchoscope is used to verify a proper position. Patient will also get an arterial line for frequent ABG (Arterial Blood Gases) samplings.

Computer generated randomization will divide patients into 2 groups. Baseline ABG will be drawn. After one lung ventilation commenced for 20 minutes, the 2nd ABG will be drawn, the surgeon who was blinded to the intervention will evaluate the quality of lung collapse using 5-point Likert scale. Then, patients will either receive a CPAP or HFHO (depends on randomization) for 20 minutes. Up on 1st intervention completion, the 3rd ABG and lung collapse evaluation will be performed.

Following the first intervention, the non-ventilated lung will be suctioned out and wait for 20 minutes. Another ABG will be sampled at this point.

The patient will receive the 2nd alternative intervention (CPAP or HFHO- depend on their randomization) for 20 minutes. The final ABG and lung collapse evaluation will be performed.

If any severe hypoxemia/ hypercarbia and marked violation of protocol occurs. Patients will be excluded.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All adult > 18 years of age undergoes lung surgeries that required one-lung ventilation

Exclusion criteria

  • emergency case
  • severe COPD
  • moderate baseline hypoxemia
  • pulmonary hypertension
  • difficult upper/lower airway
  • BMI > 35
  • severe pneumonia
  • bronchial lavage
  • massive hemoptysis

Treatment and study plan

CPAP

Device

Conventional CPAP

Other names: Mallinkrodt CPAP

HFHO

Device

A device that can provide heated humidified oxygen up to 30-60 liter per minute, FiO2 (fraction of inspired oxygen) 0.21-0.95

Other names: Optiflow, Airvo

Primary outcomes

  1. Number of participants with improved oxygenation.

    Time frame: 20 minutes

    Improvement of gas exchanges by arterial blood gases

Secondary outcomes

  1. Quality of lung collapsed.

    Time frame: 20 minutes

    Lung collapse quality by surgeon using 5-point Likert scale where 5 = very good, 4= good, 3 = acceptable, 2 = poor and 1= very poor

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

Effect of High Flow Humidified Oxygen on Non-ventilated Lung During Thoracic Surgery: a Cross-over Study Compared With Conventional CPAP (Continuous Positive Airway Pressure)

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 28, 2019
Registry last updated
May 21, 2021

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.

Published trials that share one or more normalized conditions with this study.