Post-operative Pulmonary ComplicationsNCT03024112
Impact of Prophylactic High Flow Nasal Oxygen in Post-Operative Thoracic Surgical Patients
A study testing Heated humified high-flow nasal cannula Oxygen and Standard oxygen therapy in people with Post-operative Pulmonary Complications, run by University of Colorado, Denver at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Post-operative Pulmonary Complications
- What is being tested?
- Heated humified high-flow nasal cannula Oxygen and Standard oxygen therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Jun 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing Thoracic surgery
- Planned admission to ICU after surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Unversity of Colorado Hospital
Aurora, Colorado, 80045
About this study
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.
Read the 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.
- Conditions
- Post-operative Pulmonary Complications
- Being tested
- Heated humified high-flow nasal cannula Oxygen, Standard oxygen therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heated humified high-flow nasal cannula OxygenDevice
Standard oxygen therapyOther
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Heated humified high-flow nasal cannula Oxygen |
| 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%. Receives: Other: Standard oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (3)
Hospital Length of Stay
length of stay from hospital admission to hospital discharge
Measured: 30 days
Lowest Oxygen Saturation Level Measured
Lowest oxygen saturation level measured during hospitalization from admission to discharge
Measured: 30 days
ICU Length of Stay
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study startAug 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-operative Pulmonary ComplicationsStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason Brainard, M.D., Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03024112
- Sponsor's protocol ID
- 12-1403
- Status last verified
- Dec 2017
- First submitted
- 10 Jan 2017
- Last updated
- 7 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: No plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Prophylactic High Flow Nasal Oxygen in Post-Operative Thoracic Surgical Patients
- ClinicalTrials.gov ID
- NCT03024112
- Acronym / sponsor ID
- 12-1403
- Conditions
- Post-operative Pulmonary Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 18 Jan 2017 (estimated)
- Results
- Posted 5 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heated humidified high-flow nasal cannula (HHFNC) oxygen | Experimental | Device: Heated humified high-flow nasal cannula OxygenThe 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 | Other: Standard oxygen therapyThe standard O2 treatment group received usual nasal cannula or face mask oxygen titrated by nurses as necessary to maintain SpO2 ≥ 90%. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing Thoracic surgery
- Planned admission to ICU after surgery
Key exclusion criteria (8 listed)
- Younger than 18
- Pregnant
- Breast feeding
- Known diagnosis of obstructive sleep apnea
- Current or previous lung transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heated humified high-flow nasal cannula Oxygen | Device | Heated humidified high-flow nasal cannula (HHFNC) oxygen |
| Standard oxygen therapy | Other | Standard oxygen Therapy |
Primary outcome
Number of Participants With Post-operative Pulmonary Complications
Time frame: 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
3 secondary outcomes
Hospital Length of Stay
Time frame: 30 days
Lowest Oxygen Saturation Level Measured
Time frame: 30 days
ICU Length of Stay
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Brainard, M.D. principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heated humified high-flow nasal cannula Oxygen and Standard oxygen therapy in people with Post-operative Pulmonary Complications, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Post-operative Pulmonary Complications (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.