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HFHO vs CPAP During Thoracic Surgery

Primary Purpose

Hypoxaemia During Surgery, Lung Hyperinflation

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
CPAP
HFHO
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoxaemia During Surgery focused on measuring High flow oxygen device, HFHO, CPAP, One-lung ventilation

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

HFHO-CPAP

CPAP-HFHO

Arm Description

This group will have HFHO before CPAP

This group will have CPAP and then HFHO

Outcomes

Primary Outcome Measures

Number of participants with improved oxygenation.
Improvement of gas exchanges by arterial blood gases

Secondary Outcome Measures

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

Full Information

First Posted
March 27, 2019
Last Updated
May 20, 2021
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT03894072
Brief Title
HFHO vs CPAP During Thoracic Surgery
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxaemia During Surgery, Lung Hyperinflation
Keywords
High flow oxygen device, HFHO, CPAP, One-lung ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
HFHO-CPAP CPAP-HFHO
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HFHO-CPAP
Arm Type
Active Comparator
Arm Description
This group will have HFHO before CPAP
Arm Title
CPAP-HFHO
Arm Type
Active Comparator
Arm Description
This group will have CPAP and then HFHO
Intervention Type
Device
Intervention Name(s)
CPAP
Other Intervention Name(s)
Mallinkrodt CPAP
Intervention Description
Conventional CPAP
Intervention Type
Device
Intervention Name(s)
HFHO
Other Intervention Name(s)
Optiflow, Airvo
Intervention Description
A device that can provide heated humidified oxygen up to 30-60 liter per minute, FiO2 (fraction of inspired oxygen) 0.21-0.95
Primary Outcome Measure Information:
Title
Number of participants with improved oxygenation.
Description
Improvement of gas exchanges by arterial blood gases
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
Quality of lung collapsed.
Description
Lung collapse quality by surgeon using 5-point Likert scale where 5 = very good, 4= good, 3 = acceptable, 2 = poor and 1= very poor
Time Frame
20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prasert Sawasdiwipachai, MD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Not yet decided

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HFHO vs CPAP During Thoracic Surgery

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