Post-operative Pulmonary Complications
Conditions
Brief summary
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
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.
Interventions
DEVICEHeated humified high-flow nasal cannula Oxygen
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Post-operative Pulmonary Complications | 30 days | The primary outcome post-operative pulmonary complication is defined as present if any one of the following criteria are met: * SpO2 \< 90% with FiO2 ≥ 50% * Dyspnea at rest * Respiratory rate \> 25 breaths/min * Active use of accessory respiratory muscles * PaO2/FiO2 ratio \< 200 * Escalation of therapy to non-invasive ventilation * Re-intubation * Occurrence of hospital-acquired pneumonia * Re-admission to the ICU |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU Length of Stay | 30 days | — |
| Hospital Length of Stay | 30 days | length of stay from hospital admission to hospital discharge |
| Lowest Oxygen Saturation Level Measured | 30 days | Lowest oxygen saturation level measured during hospitalization from admission to discharge |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 18 |
| 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 | 26 |
| Total | 44 |
Baseline characteristics
| Characteristic | Standard Oxygen Therapy | Heated Humidified High-flow Nasal Cannula (HHFNC) Oxygen | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 8 Participants | 18 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 10 Participants | 26 Participants |
| Age, Continuous | 59 years | 57 years | 58 years |
| Region of Enrollment United States | 26 participants | 18 participants | 44 participants |
| Sex: Female, Male Female | 12 Participants | 10 Participants | 22 Participants |
| Sex: Female, Male Male | 14 Participants | 8 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 26 |
| other Total, other adverse events | 2 / 18 | 2 / 26 |
| serious Total, serious adverse events | 0 / 18 | 0 / 26 |
Outcome results
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: * SpO2 \< 90% with FiO2 ≥ 50% * Dyspnea at rest * Respiratory rate \> 25 breaths/min * Active use of accessory respiratory muscles * PaO2/FiO2 ratio \< 200 * Escalation of therapy to non-invasive ventilation * Re-intubation * Occurrence of hospital-acquired pneumonia * Re-admission to the ICU
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Heated Humidified High-flow Nasal Cannula (HHFNC) Oxygen | Number of Participants With Post-operative Pulmonary Complications | 1 Participants |
| Standard Oxygen Therapy | Number of Participants With Post-operative Pulmonary Complications | 2 Participants |
p-value: 0.68t-test, 1 sided
Secondary
Hospital Length of Stay
length of stay from hospital admission to hospital discharge
Time frame: 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Heated Humidified High-flow Nasal Cannula (HHFNC) Oxygen | Hospital Length of Stay | 6.6 Days | Standard Deviation 2.1 |
| Standard Oxygen Therapy | Hospital Length of Stay | 9.5 Days | Standard Deviation 7 |
Secondary
ICU Length of Stay
Time frame: 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Heated Humidified High-flow Nasal Cannula (HHFNC) Oxygen | ICU Length of Stay | 2 Days | Standard Deviation 1.2 |
| Standard Oxygen Therapy | ICU Length of Stay | 3.2 Days | Standard Deviation 3.8 |
Secondary
Lowest Oxygen Saturation Level Measured
Lowest oxygen saturation level measured during hospitalization from admission to discharge
Time frame: 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Heated Humidified High-flow Nasal Cannula (HHFNC) Oxygen | Lowest Oxygen Saturation Level Measured | 88 percentage of oxygen saturation | Standard Deviation 7 |
| Standard Oxygen Therapy | Lowest Oxygen Saturation Level Measured | 84 percentage of oxygen saturation | Standard Deviation 7 |