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Impact of Prophylactic High Flow Nasal Oxygen in Post-Operative Thoracic Surgical Patients

NCT ID: NCT03024112

Last Updated: 2017-12-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-06-30

Brief Summary

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The Investigators goal was to study the effect of high flow nasal cannula oxygen (HFNC) on the rate of post-operative pulmonary complications in thoracic surgical patients. The Investigators hypothesis is that prophylactic HFNC oxygen, as compared to standard oxygen treatment, will reduce the incidence of postoperative pulmonary complications, improve post-operative pulmonary function, and reduce Intensive Care Unit (ICU) and hospital length of stay.

Detailed Description

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The Investigators goal was to study the effect of high flow nasal cannula oxygen (HFNC) on the rate of post-operative pulmonary complications in thoracic surgical patients. The Investigators hypothesis is that prophylactic HFNC oxygen, as compared to standard oxygen treatment, will reduce the incidence of postoperative pulmonary complications, improve post-operative pulmonary function, and reduce ICU and hospital length of stay.

Conditions

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Post-operative Pulmonary Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Heated humidified high-flow nasal cannula (HHFNC) oxygen

The intervention group received HHFNC O2 at a set flow of 40L/min. FiO2 was titrated by respiratory therapists to maintain SpO2 ≥ 90%. The HHFNC O2 apparatus included: 1) Air-Oxygen blender - capable of delivering 21-100% FiO2 at flow rates up to 60L/min, 2) Heated Humidifier - providing active heating and humidification to the delivered air-O2 blend, 3) Nasal cannula - larger diameter, slightly elongated nasal cannula with single limb connection to humidifier

Group Type EXPERIMENTAL

Heated humified high-flow nasal cannula Oxygen

Intervention Type DEVICE

Standard oxygen Therapy

The standard O2 treatment group received usual nasal cannula or face mask oxygen titrated by nurses as necessary to maintain SpO2 ≥ 90%.

Group Type ACTIVE_COMPARATOR

Standard oxygen therapy

Intervention Type OTHER

Interventions

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Heated humified high-flow nasal cannula Oxygen

Intervention Type DEVICE

Standard oxygen therapy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Undergoing Thoracic surgery
* Planned admission to ICU after surgery

Exclusion Criteria

* Younger than 18
* Pregnant
* Breast feeding
* Known diagnosis of obstructive sleep apnea
* Current or previous lung transplant
* Pneumonectomy
* Home oxygen greater than 4L/minute
* Inability to adhere to assigned treatment prior to 48 hours of surgery or until transferred to a floor
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jason Brainard, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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Unversity of Colorado Hospital

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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12-1403

Identifier Type: -

Identifier Source: org_study_id