HFHO vs CPAP During Thoracic Surgery

NCT ID: NCT03894072

Last Updated: 2021-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2019-11-30

Brief Summary

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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

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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:-

1. Emergency case.
2. Patients with severe COPD(Chronic Obstructive Pulmonary Diseases).
3. Patients with moderate baseline hypoxemia (SpO2 \< 90% on room air).
4. Patients with severe hemoptysis.
5. Patients with upper or lower airway abnormalities.
6. Patients undergo pulmonary lavage.
7. Patients with known pulmonary hypertension.
8. Patients with known pulmonary/tracheobronchial infections.
9. Patients with suspected difficult airway.
10. Patients with BMI over 35.
11. 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.

Conditions

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Hypoxaemia During Surgery Lung Hyperinflation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

HFHO-CPAP CPAP-HFHO
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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HFHO-CPAP

This group will have HFHO before CPAP

Group Type ACTIVE_COMPARATOR

CPAP

Intervention Type DEVICE

Conventional CPAP

HFHO

Intervention Type 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

CPAP-HFHO

This group will have CPAP and then HFHO

Group Type ACTIVE_COMPARATOR

CPAP

Intervention Type DEVICE

Conventional CPAP

HFHO

Intervention Type 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

Interventions

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CPAP

Conventional CPAP

Intervention Type DEVICE

HFHO

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

Intervention Type DEVICE

Other Intervention Names

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Mallinkrodt CPAP Optiflow, Airvo

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Prasert Sawasdiwipachai

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Prasert Sawasdiwipachai, MD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

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Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital

Bangkok, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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Si066/2019

Identifier Type: -

Identifier Source: org_study_id

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