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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heated humidified high-flow nasal cannula (HHFNC) oxygen | Experimental | 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 |
|
| Standard oxygen Therapy | Active Comparator | The standard O2 treatment group received usual nasal cannula or face mask oxygen titrated by nurses as necessary to maintain SpO2 ≥ 90%. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heated humified high-flow nasal cannula Oxygen | Device |
| ||
| Standard oxygen therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Post-operative Pulmonary Complications | The primary outcome "post-operative pulmonary complication" is defined as present if any one of the following criteria are met:
| 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Length of Stay | length of stay from hospital admission to hospital discharge | 30 days |
| Lowest Oxygen Saturation Level Measured | Lowest oxygen saturation level measured during hospitalization from admission to discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Brainard, M.D. | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unversity of Colorado Hospital | Aurora | Colorado | 80045 | United States |
No plan to share IPD
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 Heated humified high-flow nasal cannula Oxygen |
| FG001 | 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%. Standard oxygen therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 Heated humified high-flow nasal cannula Oxygen |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Post-operative Pulmonary Complications | The primary outcome "post-operative pulmonary complication" is defined as present if any one of the following criteria are met:
| Posted | Count of Participants | Participants | 30 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 Heated humified high-flow nasal cannula Oxygen |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary Complications | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jason Brainard | University of Colorado, Denver | 720-848-3257 | Jason.Brainard@ucdenver.edu |
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| Other |
|
| 30 days |
| ICU Length of Stay | 30 days |
| BG001 | 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%. Standard oxygen therapy |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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%. Standard oxygen therapy |
|
|
|
| Secondary | Hospital Length of Stay | length of stay from hospital admission to hospital discharge | Posted | Mean | Standard Deviation | Days | 30 days |
|
|
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| Secondary | Lowest Oxygen Saturation Level Measured | Lowest oxygen saturation level measured during hospitalization from admission to discharge | Posted | Mean | Standard Deviation | percentage of oxygen saturation | 30 days |
|
|
|
| Secondary | ICU Length of Stay | Posted | Mean | Standard Deviation | Days | 30 days |
|
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|
| 0 |
| 18 |
| 0 |
| 18 |
| 2 |
| 18 |
| EG001 | 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%. Standard oxygen therapy | 0 | 26 | 0 | 26 | 2 | 26 |
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