Respiratory InsufficiencyNCT02544477
High-flow Nasal Cannula Oxygen Versus Conventional Oxygen Therapy After Pulmonary Lobectomy
A study testing High-flow Nasal Cannula Oxygen (HFNCO) and Conventional oxygen treatment in people with Respiratory Insufficiency and Lung Cancer, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
The primary objective of this study is to evaluate the effect of early application of nasal high flow oxygen therapy after pulmonary lobectomy on the incidence of postoperative hypoxemia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Insufficiency, Lung Cancer
- What is being tested?
- High-flow Nasal Cannula Oxygen (HFNCO) and Conventional oxygen treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2015to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- planned pulmonary lobectomy for lung cancer
Who cannot join
- age <18 years
- patient refusal
- body mass index ≥35 kg/m2
- sleep apnea syndrome
- tracheostomy
- home oxygen therapy
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to evaluate the effect of early application of nasal high flow oxygen therapy after pulmonary lobectomy on the incidence of postoperative hypoxemia
Read the detailed description
High-flow nasal cannula oxygen (HFNCO) treatment has been showed to have several clinical advantages compared with conventional oxygen therapy. Currently, no reports have described the effects of HFNCO in postoperative patients after thoracic surgery. The primary objective of this study is to determine the incidence of postoperative hypoxemia (defined as a PaO2/FiO2 ratio <300) in patients with lung cancer after pulmonary lobectomy.
In the postoperative period after extubation, patients will be randomly assigned to either:
- standard oxygen therapy group (control group) or
- HFNCO group (study group).
In the control group, patients will receive oxygen treatment by means of a conventional face mask, with a level of fraction of inspired oxygen (FiO2) set to maintain peripheral oxygen saturation (SpO2) = 92% - 98%. Patients in the study group will be given HFNCO treatment with a gas flow level = 50 L/min and a FiO2 set to maintain peripheral oxygen saturation (SpO2) = 92% - 98%. After 48 hours from study entry, all patients will be evaluated for possible interruption of oxygen treatment on the basis of their clinical conditions.
- Conditions
- Respiratory Insufficiency, Lung Cancer
- Being tested
- High-flow Nasal Cannula Oxygen (HFNCO), Conventional oxygen treatment
- Medical subject headings
- Respiratory Insufficiency, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-flow Nasal Cannula Oxygen (HFNCO)Device
Conventional oxygen treatmentDevice
| Study group | Role | What they receive |
|---|---|---|
| High-flow nasal cannula oxygen (HFNCO) | Experimental | Patients will receive HFNCO treatment with a gas flow level = 50 L/min and a FiO2 set to maintain peripheral oxygen saturation (SpO2) of 92% - 98%. Receives: Device: High-flow Nasal Cannula Oxygen (HFNCO) |
| standard oxygen therapy | Active comparator | Patients will receive oxygen treatment by means of a conventional face mask, with a level of fraction of inspired oxygen (FiO2) set to maintain peripheral oxygen saturation (SpO2) of 92% - 98%. Receives: Device: Conventional oxygen treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with hypoxemia (defined as a PaO2/FiO2 ratio <300) after pulmonary lobectomy in patients with lung cancer
Measured: during the first 96 hours after surgery
Secondary outcomes (4)
Number of patients with SpO2 <93% in room air
Measured: after 48 hours from surgery and until 7th post operative day
Number of patients undergoing endotracheal intubation or non-invasive ventilation for acute respiratory failure
Respiratory failure will be defined as the presence of at least two of the following:
- respiratory acidosis (arterial pH ≤7.35 with PaCO2 ≥ 45 mm Hg);
- SpO2 < 90% or PaO2 < 60 mmHg at an FiO2 ≥ 0.5;
- respiratory frequency > 35/min;
- altered state of consciousness;
- clinical signs of respiratory muscle fatigue.
Respiratory failure will be treated using noninvasive ventilation (NIV), except when endotracheal intubation (ETI) will be required, i.e., when any of the following clinical events will be present:
- respiratory or cardiac arrest;
- respiratory pauses with loss of consciousness or gasping;
- psychomotor agitation inadequately controlled by sedation;
- massive aspiration;
- persistent inability to remove respiratory secretions;
- heart rate < 50/min with loss of alertness;
- severe hemodynamic instability without response to fluids and vasoactive drugs. Patients with deterioration of blood gases or tachypnea despite 1 hour of NIV will undergo ETI.
Measured: during the first 7 days after surgery
Postoperative pulmonary complications
Measured: during the first 7 days after surgery
Respiratory discomfort evaluated by VAS (visual analogic scale) ranging from 0 (no discomfort) to 10 (maximum imaginable discomfort)
Measured: during the first 96 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionApr 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Teresa Congedo, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02544477
- Sponsor's protocol ID
- HFNC after pulmonary lobectomy
- Status last verified
- Dec 2018
- First submitted
- 26 Aug 2015
- Last updated
- 24 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Pennisi MA, Bello G, Congedo MT, Montini L, Nachira D, Ferretti GM, Meacci E, Gualtieri E, De Pascale G, Grieco DL, Margaritora S, Antonelli M. Early nasal high-flow versus Venturi mask oxygen therapy after lung resection: a randomized trial. Crit Care. 2019 Feb 28;23(1):68. doi: 10.1186/s13054-019-2361-5.
PubMed 30819227
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-flow Nasal Cannula Oxygen Versus Conventional Oxygen Therapy After Pulmonary Lobectomy
- ClinicalTrials.gov ID
- NCT02544477
- Acronym / sponsor ID
- HFNC after pulmonary lobectomy
- Conditions
- Respiratory Insufficiency, Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 9 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the effect of early application of nasal high flow oxygen therapy after pulmonary lobectomy on the incidence of postoperative hypoxemia
Detailed description
High-flow nasal cannula oxygen (HFNCO) treatment has been showed to have several clinical advantages compared with conventional oxygen therapy. Currently, no reports have described the effects of HFNCO in postoperative patients after thoracic surgery. The primary objective of this study is to determine the incidence of postoperative hypoxemia (defined as a PaO2/FiO2 ratio <300) in patients with lung cancer after pulmonary lobectomy.
In the postoperative period after extubation, patients will be randomly assigned to either:
- standard oxygen therapy group (control group) or
- HFNCO group (study group).
In the control group, patients will receive oxygen treatment by means of a conventional face mask, with a level of fraction of inspired oxygen (FiO2) set to maintain peripheral oxygen saturation (SpO2) = 92% - 98%. Patients in the study group will be given HFNCO treatment with a gas flow level = 50 L/min and a FiO2 set to maintain peripheral oxygen saturation (SpO2) = 92% - 98%. After 48 hours from study entry, all patients will be evaluated for possible interruption of oxygen treatment on the basis of their clinical conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-flow nasal cannula oxygen (HFNCO) | Experimental | Device: High-flow Nasal Cannula Oxygen (HFNCO)Patients will receive HFNCO treatment with a gas flow level = 50 L/min and a FiO2 set to maintain peripheral oxygen saturation (SpO2) of 92% - 98%. |
| standard oxygen therapy | Active comparator | Device: Conventional oxygen treatmentPatients will receive oxygen treatment by means of a conventional face mask, with a level of fraction of inspired oxygen (FiO2) set to maintain peripheral oxygen saturation (SpO2) of 92% - 98%. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- planned pulmonary lobectomy for lung cancer
Key exclusion criteria (7 listed)
- age <18 years
- patient refusal
- body mass index ≥35 kg/m2
- sleep apnea syndrome
- tracheostomy
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 |
|---|---|---|
| High-flow Nasal Cannula Oxygen (HFNCO) | Device | High-flow nasal cannula oxygen (HFNCO) |
| Conventional oxygen treatment | Device | standard oxygen therapy |
Primary outcome
Number of patients with hypoxemia (defined as a PaO2/FiO2 ratio <300) after pulmonary lobectomy in patients with lung cancer
Time frame: during the first 96 hours after surgery
4 secondary outcomes
Number of patients with SpO2 <93% in room air
Time frame: after 48 hours from surgery and until 7th post operative day
Number of patients undergoing endotracheal intubation or non-invasive ventilation for acute respiratory failure
Time frame: during the first 7 days after surgery
Postoperative pulmonary complications
Time frame: during the first 7 days after surgery
Respiratory discomfort evaluated by VAS (visual analogic scale) ranging from 0 (no discomfort) to 10 (maximum imaginable discomfort)
Time frame: during the first 96 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2018.
- Derived from this study: PubMed 30819227Pennisi MA, Bello G, Congedo MT, Montini L, Nachira D, Ferretti GM, Meacci E, Gualtieri E, De Pascale G, Grieco DL, Margaritora S, Antonelli M. Early nasal high-flow versus Venturi mask oxygen therapy after lung resection: a randomized trial. Crit Care. 2019 Feb 28;23(1):68. doi: 10.1186/s13054-019-2361-5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-flow Nasal Cannula Oxygen (HFNCO) and Conventional oxygen treatment in people with Respiratory Insufficiency and Lung Cancer, run by Catholic University of the Sacred Heart at 1 site in Italy.
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 1 inclusion and 7 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 24 Dec 2018. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 patients with hypoxemia (defined as a PaO2/FiO2 ratio <300) after pulmonary lobectomy in patients with lung cancer (time frame: during the first 96 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02544477, which also lists 1 linked publication.
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 24 Dec 2018.