Thoracic SurgeryNCT05910788
High-Flow Nasal Catheter (HFNC) Compared With Conventional Oxygenation
A study testing high flow nasal cannula in people with Thoracic Surgery, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial summary
The purpose of this study, is to clarify whether there is benefit from the perioperative use of HFNC in thoracic surgeries, from intubation to the postoperative period, evaluating hipoxemia during orotracheal intubation, immediate complications after intubation, mortality and in-hospital complications. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thoracic Surgery
- What is being tested?
- high flow nasal cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteBrazil
- Study dates
- 28 Jul 2023to 30 Dec 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients over 18 years of age who will undergo elective thoracic surgery and who have an ARISCAT score > 26.
Who cannot join
- Patients who need urgent/emergency surgery, pregnant women, who do not have an ARISCAT score > 26 and those who refuse to participate in the study.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Desejo Tarso Maioli
Bento Gonçalves, Rio Grande do Sul, 95700348
Desire T Maioli, md, 555430557676, desiretarso@yahoo.com.br
About this study
Official title: High-Flow Nasal Catheter (HFNC) Compared With Conventional Oxygenation During the Perioperative Period of Patients Undergoing Thoracic Surgery.
The purpose of this study, is to clarify whether there is benefit from the perioperative use of HFNC in thoracic surgeries, from intubation to the postoperative period, evaluating hipoxemia during orotracheal intubation, immediate complications after intubation, mortality and in-hospital complications.
Read the detailed description
High-flow Nasal Catheter (HFNC) compared to oxygenation conventional during the perioperative period of patients undergoing thoracic surgery The increase in surgeries performed worldwide, with today an estimate of more than 300 million surgeries/year, makes us increasingly need knowledge and strategies to improve perioperative care. Complications in this period are responsible for an increase in morbidity and mortality of patients, reducing the effectiveness of the surgical treatment, mainly in developing countries. The use of a nasal cannula high-flow (HFNC) oxygen during the perioperative period offers a promising technique to improve the lung function of these patients, enabling better outcomes.
The purpose of this study, therefore, is to clarify whether there is benefit from the perioperative use of HFNC, in thoracic surgeries, from intubation to the postoperative period, evaluating mortality and in-hospital complications.
Primary and secondary objectives
Main goal
- To evaluate the incidence of in-hospital pulmonary complications in 30 days in participants submitted to the use of HFNC in the perioperative period of participants undergoing thoracic surgery, when compared to the use of conventional oxygen therapy.
- To evaluate in-hospital postoperative mortality within 30 days.
Secondary objectives
- Assess the incidence of hypoxemia during orotracheal intubation and extubation
- Assess the incidence of immediate complications after intubation and extubation (desaturation, failure of intubation/ extubation)
It will be a randomized, non-blinded, single-center clinical trial. Participants (older than 18 years old) who undergo thoracic surgery and who are at surgical risk for postoperative complications with ARISCAT > 26 (risk score for pulmonary complications) will be allocated consecutively and randomized to participate in the intervention group or control, receiving written informed consent to the study and interventions. The study will be carried out at Hospital Tacchini, from July 2023 to June 2024.
Control group will receive conventional oxygen therapy, and the intervention group will receive HFNC therapy at induction of anesthesia and postoperatively, after extubation.
Oxygenation will be performed, according to the randomization, in the control group, by mask facial, with 100% oxygen and flow of 10 L.min-1. The intervention group will receive oxygenby 100% HFNC with a flow of 40 L.min-1 being increased to 70 L.min-1 during the periodof apnea.
A rapid sequence of orotracheal intubation will be performed, considering the time of apnea the moment of disappearance of the capnography line until the first ventilation after tube placement. Difficulties and complications in carrying out this step will be described. A oxygen saturation will be measured before the start of pre-oxygenation and will be considered hypoxemia, any measurement below 90% saturation, during the initiation of the rapid sequence intubation up to 5 minutes after it, in both groups. All participants will be intubated according to current orotracheal intubation guidelines. After surgery, participants who are extubated in the operating room or in the intensive care unit, will remain in the control and intervention groups and will receive therapy for conventional oxygen or HFNC, respectively. The fraction of inspired oxygen (FiO2) will be titrated until pulse oximetry is above 95%, which is also reduced to the level minimum, to achieve this objective. In the control group, oxygen will be offered through a nasal catheter or face mask and those in the intervention group will receive oxygen through HFNC with flows adjusted between 30 and 50 L.min-1, depending on the respiratory rate (less than 16) and the patient comfort.
Data and statistics analysis strategy The data, after being collected, will be expressed as mean and standard deviation or absolute frequency and relative. Data normality will be tested by the Kolmogorov-Smirnov test. The difference Significant difference between groups will be analyzed using Student's t test for data for parametric data and for non-parametric data the Wilcoxon test will be used. The program used will be the Statistical Package for the Social Sciences, version 20 (SPSS Inc., Chicago, IL,USA) and the significance level adopted will be p<0.05.
Calculation and/or justification of the sample size According to the literature, patients undergoing thoracic surgery may present severe complications such as postoperative hypoxemia in up to 30% of cases, after extubation. Based on the literature review, the sample calculation should be 45 patients for each group. For the sample calculation, we considered the value of β of 20% and α of 5%.
. Using a effect size (calculated from the article data) of 0.6, a statistical power of 80% and a significance level of p<0.05 (or 5%), the investigators obtained as a result the n of 90 volunteers per group (final sample, excluding possible losses). The G*Power program version 3.1.9.2 for Windows (Franz Faul, University Kiel, Germany) was used to perform the calculation.
- Conditions
- Thoracic Surgery
- Being tested
- high flow nasal cannula
- Keywords
- Thoracic surgery, High flow nasal cannula, Pulmonary complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high flow nasal cannulaDevice
The purpose of this intervention is clarify the benefit with the perioperative use of HFNC, in thoracic surgeries, from intubation to the postoperative period, evaluating mortality and in-hospital complications.
is to clarify whether there is benefit from the perioperative use of HFNC, in thoracic surgeries, from intubation to the postoperative period, evaluating mortality and in-hospital complications.
| Study group | Role | What they receive |
|---|---|---|
| HFNC | Active comparator | The intervention group will receive HFNC therapy at induction of anesthesia. The intervention group will receive oxygen by 100% HFNC with a flow of 40 L.min-1 being increased to 70 L.min-1 during the period of apnea. A rapid sequence of orotracheal intubation will be performed, considering the time of apnea the moment of disappearance of the capnography line until the first ventilation after tube placement. Receives: Device: high flow nasal cannula |
| Convencional oxygen therapy | No intervention | Control group will receive conventional oxygen therapy by mask facial, with 100% oxygen and flow of 10 L.min-1.After surgery, patients who are extubated in the operating room or in theintensive care unit, will remain in the control and intervention groups and will receive therapy for conventional oxygen or HFNC, respectively. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Complications
To evaluate the incidence of in-hospital pulmonary complications in 30 days in patients submitted to the use of HFNC in the perioperative period of patients undergoing thoracic surgery, when compared to the use of conventional oxygen therapy. extubation
Measured: 30 days
Mortality
To evaluate in-hospital postoperative mortality within 30 days.
Measured: 30 days
Secondary outcomes (2)
Incidence of hipoxemia
- Assess the incidence of hypoxemia during orotracheal intubation and extubation.
Measured: 5 minuts
Complications after intubation and extubation
Assess the incidence of immediate complications after intubation and extubation (desaturation, failure of intubation and extubation)
Measured: 5 minuts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2023
- Study start28 Jul 2023
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Thoracic SurgeryStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Main goal * To evaluate the incidence of in-hospital pulmonary complications in 30 days in patients submitted to the use of HFNC in the perioperative period of patients undergoing thoracic surgery, * To evaluate in-hospital postoperative mortality within 30 days. intubation) Secondary objectives * Assess the incidence of hypoxemia during orotracheal intubation/ extubation * Assess the incidence of immediate complications after intubation/ extubation(desaturation, failure of intubation/ extubation)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Desire Tarso Maioli, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05910788
- Sponsor's protocol ID
- U1111-1292-9259
- Status last verified
- Jul 2023
- First submitted
- 29 May 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nepogodiev D, Martin J, Biccard B, Makupe A, Bhangu A; National Institute for Health Research Global Health Research Unit on Global Surgery. Global burden of postoperative death. Lancet. 2019 Feb 2;393(10170):401. doi: 10.1016/S0140-6736(18)33139-8. No abstract available.
PubMed 30722955Ahmad T, Bouwman RA, Grigoras I, Aldecoa C, Hofer C, Hoeft A, Holt P, Fleisher LA, Buhre W, Pearse RM; International Surgical Outcomes Study (ISOS) group. Use of failure-to-rescue to identify international variation in postoperative care in low-, middle- and high-income countries: a 7-day cohort study of elective surgery. Br J Anaesth. 2017 Aug 1;119(2):258-266. doi: 10.1093/bja/aex185.
PubMed 28854536Serpa Neto A, Hemmes SN, Barbas CS, Beiderlinden M, Fernandez-Bustamante A, Futier E, Hollmann MW, Jaber S, Kozian A, Licker M, Lin WQ, Moine P, Scavonetto F, Schilling T, Selmo G, Severgnini P, Sprung J, Treschan T, Unzueta C, Weingarten TN, Wolthuis EK, Wrigge H, Gama de Abreu M, Pelosi P, Schultz MJ; PROVE Network investigators. Incidence of mortality and morbidity related to postoperative lung injury in patients who have undergone abdominal or thoracic surgery: a systematic review and meta-analysis. Lancet Respir Med. 2014 Dec;2(12):1007-15. doi: 10.1016/S2213-2600(14)70228-0. Epub 2014 Nov 13.
PubMed 25466352Canet J, Gallart L, Gomar C, Paluzie G, Valles J, Castillo J, Sabate S, Mazo V, Briones Z, Sanchis J; ARISCAT Group. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010 Dec;113(6):1338-50. doi: 10.1097/ALN.0b013e3181fc6e0a.
PubMed 21045639Arozullah AM, Daley J, Henderson WG, Khuri SF. Multifactorial risk index for predicting postoperative respiratory failure in men after major noncardiac surgery. The National Veterans Administration Surgical Quality Improvement Program. Ann Surg. 2000 Aug;232(2):242-53. doi: 10.1097/00000658-200008000-00015.
PubMed 10903604Meara JG, Leather AJ, Hagander L, Alkire BC, Alonso N, Ameh EA, Bickler SW, Conteh L, Dare AJ, Davies J, Merisier ED, El-Halabi S, Farmer PE, Gawande A, Gillies R, Greenberg SL, Grimes CE, Gruen RL, Ismail EA, Kamara TB, Lavy C, Lundeg G, Mkandawire NC, Raykar NP, Riesel JN, Rodas E, Rose J, Roy N, Shrime MG, Sullivan R, Verguet S, Watters D, Weiser TG, Wilson IH, Yamey G, Yip W. Global Surgery 2030: evidence and solutions for achieving health, welfare, and economic development. Int J Obstet Anesth. 2016 Feb;25:75-8. doi: 10.1016/j.ijoa.2015.09.006. Epub 2015 Sep 30. No abstract available.
PubMed 26597405Wittenstein J, Ball L, Pelosi P, Gama de Abreu M. High-flow nasal cannula oxygen therapy in patients undergoing thoracic surgery: current evidence and practice. Curr Opin Anaesthesiol. 2019 Feb;32(1):44-49. doi: 10.1097/ACO.0000000000000682.
PubMed 30543553Papazian L, Corley A, Hess D, Fraser JF, Frat JP, Guitton C, Jaber S, Maggiore SM, Nava S, Rello J, Ricard JD, Stephan F, Trisolini R, Azoulay E. Use of high-flow nasal cannula oxygenation in ICU adults: a narrative review. Intensive Care Med. 2016 Sep;42(9):1336-49. doi: 10.1007/s00134-016-4277-8. Epub 2016 Mar 11.
PubMed 26969671Spence EA, Rajaleelan W, Wong J, Chung F, Wong DT. The Effectiveness of High-Flow Nasal Oxygen During the Intraoperative Period: A Systematic Review and Meta-analysis. Anesth Analg. 2020 Oct;131(4):1102-1110. doi: 10.1213/ANE.0000000000005073.
PubMed 32925331Lodenius A, Piehl J, Ostlund A, Ullman J, Jonsson Fagerlund M. Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) vs. facemask breathing pre-oxygenation for rapid sequence induction in adults: a prospective randomised non-blinded clinical trial. Anaesthesia. 2018 May;73(5):564-571. doi: 10.1111/anae.14215. Epub 2018 Jan 13.
PubMed 29330853Pennisi 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 30819227Brainard J, Scott BK, Sullivan BL, Fernandez-Bustamante A, Piccoli JR, Gebbink MG, Bartels K. Heated humidified high-flow nasal cannula oxygen after thoracic surgery - A randomized prospective clinical pilot trial. J Crit Care. 2017 Aug;40:225-228. doi: 10.1016/j.jcrc.2017.04.023. Epub 2017 Apr 19.
PubMed 28454060Yu Y, Qian X, Liu C, Zhu C. Effect of High-Flow Nasal Cannula versus Conventional Oxygen Therapy for Patients with Thoracoscopic Lobectomy after Extubation. Can Respir J. 2017;2017:7894631. doi: 10.1155/2017/7894631. Epub 2017 Feb 19.
PubMed 28298878Fraser JF, Spooner AJ, Dunster KR, Anstey CM, Corley A. Nasal high flow oxygen therapy in patients with COPD reduces respiratory rate and tissue carbon dioxide while increasing tidal and end-expiratory lung volumes: a randomised crossover trial. Thorax. 2016 Aug;71(8):759-61. doi: 10.1136/thoraxjnl-2015-207962. Epub 2016 Mar 25.
PubMed 27015801Sklar MC, Dres M, Rittayamai N, West B, Grieco DL, Telias I, Junhasavasdikul D, Rauseo M, Pham T, Madotto F, Campbell C, Tullis E, Brochard L. High-flow nasal oxygen versus noninvasive ventilation in adult patients with cystic fibrosis: a randomized crossover physiological study. Ann Intensive Care. 2018 Sep 5;8(1):85. doi: 10.1186/s13613-018-0432-4.
PubMed 30187270
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Flow Nasal Catheter (HFNC) Compared With Conventional Oxygenation During the Perioperative Period of Patients Undergoing Thoracic Surgery.
- ClinicalTrials.gov ID
- NCT05910788
- Acronym / sponsor ID
- U1111-1292-9259
- Conditions
- Thoracic Surgery
- Keywords
- Thoracic surgery, High flow nasal cannula, Pulmonary complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- 28 Jul 2023 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 20 Jun 2023 (actual)
- 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 purpose of this study, is to clarify whether there is benefit from the perioperative use of HFNC in thoracic surgeries, from intubation to the postoperative period, evaluating hipoxemia during orotracheal intubation, immediate complications after intubation, mortality and in-hospital complications.
Detailed description
High-flow Nasal Catheter (HFNC) compared to oxygenation conventional during the perioperative period of patients undergoing thoracic surgery The increase in surgeries performed worldwide, with today an estimate of more than 300 million surgeries/year, makes us increasingly need knowledge and strategies to improve perioperative care. Complications in this period are responsible for an increase in morbidity and mortality of patients, reducing the effectiveness of the surgical treatment, mainly in developing countries. The use of a nasal cannula high-flow (HFNC) oxygen during the perioperative period offers a promising technique to improve the lung function of these patients, enabling better outcomes.
The purpose of this study, therefore, is to clarify whether there is benefit from the perioperative use of HFNC, in thoracic surgeries, from intubation to the postoperative period, evaluating mortality and in-hospital complications.
Primary and secondary objectives
Main goal
- To evaluate the incidence of in-hospital pulmonary complications in 30 days in participants submitted to the use of HFNC in the perioperative period of participants undergoing thoracic surgery, when compared to the use of conventional oxygen therapy.
- To evaluate in-hospital postoperative mortality within 30 days.
Secondary objectives
- Assess the incidence of hypoxemia during orotracheal intubation and extubation
- Assess the incidence of immediate complications after intubation and extubation (desaturation, failure of intubation/ extubation)
It will be a randomized, non-blinded, single-center clinical trial. Participants (older than 18 years old) who undergo thoracic surgery and who are at surgical risk for postoperative complications with ARISCAT > 26 (risk score for pulmonary complications) will be allocated consecutively and randomized to participate in the intervention group or control, receiving written informed consent to the study and interventions. The study will be carried out at Hospital Tacchini, from July 2023 to June 2024.
Control group will receive conventional oxygen therapy, and the intervention group will receive HFNC therapy at induction of anesthesia and postoperatively, after extubation.
Oxygenation will be performed, according to the randomization, in the control group, by mask facial, with 100% oxygen and flow of 10 L.min-1. The intervention group will receive oxygenby 100% HFNC with a flow of 40 L.min-1 being increased to 70 L.min-1 during the periodof apnea.
A rapid sequence of orotracheal intubation will be performed, considering the time of apnea the moment of disappearance of the capnography line until the first ventilation after tube placement. Difficulties and complications in carrying out this step will be described. A oxygen saturation will be measured before the start of pre-oxygenation and will be considered hypoxemia, any measurement below 90% saturation, during the initiation of the rapid sequence intubation up to 5 minutes after it, in both groups. All participants will be intubated according to current orotracheal intubation guidelines. After surgery, participants who are extubated in the operating room or in the intensive care unit, will remain in the control and intervention groups and will receive therapy for conventional oxygen or HFNC, respectively. The fraction of inspired oxygen (FiO2) will be titrated until pulse oximetry is above 95%, which is also reduced to the level minimum, to achieve this objective. In the control group, oxygen will be offered through a nasal catheter or face mask and those in the intervention group will receive oxygen through HFNC with flows adjusted between 30 and 50 L.min-1, depending on the respiratory rate (less than 16) and the patient comfort.
Data and statistics analysis strategy The data, after being collected, will be expressed as mean and standard deviation or absolute frequency and relative. Data normality will be tested by the Kolmogorov-Smirnov test. The difference Significant difference between groups will be analyzed using Student's t test for data for parametric data and for non-parametric data the Wilcoxon test will be used. The program used will be the Statistical Package for the Social Sciences, version 20 (SPSS Inc., Chicago, IL,USA) and the significance level adopted will be p<0.05.
Calculation and/or justification of the sample size According to the literature, patients undergoing thoracic surgery may present severe complications such as postoperative hypoxemia in up to 30% of cases, after extubation. Based on the literature review, the sample calculation should be 45 patients for each group. For the sample calculation, we considered the value of β of 20% and α of 5%.
. Using a effect size (calculated from the article data) of 0.6, a statistical power of 80% and a significance level of p<0.05 (or 5%), the investigators obtained as a result the n of 90 volunteers per group (final sample, excluding possible losses). The G*Power program version 3.1.9.2 for Windows (Franz Faul, University Kiel, Germany) was used to perform the calculation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Main goal * To evaluate the incidence of in-hospital pulmonary complications in 30 days in patients submitted to the use of HFNC in the perioperative period of patients undergoing thoracic surgery, * To evaluate in-hospital postoperative mortality within 30 days. intubation) Secondary objectives * Assess the incidence of hypoxemia during orotracheal intubation/ extubation * Assess the incidence of immediate complications after intubation/ extubation(desaturation, failure of intubation/ extubation)
| Arm | Type | Receives |
|---|---|---|
| HFNC | Active comparator | Device: high flow nasal cannulaThe intervention group will receive HFNC therapy at induction of anesthesia. The intervention group will receive oxygen by 100% HFNC with a flow of 40 L.min-1 being increased to 70 L.min-1 during the period of apnea. A rapid sequence of orotracheal intubation will be performed, considering the time of apnea the moment of disappearance of the capnography line until the first ventilation after tube placement. |
| Convencional oxygen therapy | No intervention | –Control group will receive conventional oxygen therapy by mask facial, with 100% oxygen and flow of 10 L.min-1.After surgery, patients who are extubated in the operating room or in theintensive care unit, will remain in the control and intervention groups and will receive therapy for conventional oxygen or HFNC, respectively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients over 18 years of age who will undergo elective thoracic surgery and who have an ARISCAT score > 26.
Key exclusion criteria (1 listed)
- Patients who need urgent/emergency surgery, pregnant women, who do not have an ARISCAT score > 26 and those who refuse to participate in the study.
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 cannulaThe purpose of this intervention is clarify the benefit with the perioperative use of HFNC, in thoracic surgeries, from intubation to the postoperative period, evaluating mortality and in-hospital complications. is to clarify whether there is benefit from the perioperative use of HFNC, in thoracic surgeries, from intubation to the postoperative period, evaluating mortality and in-hospital complications. | Device | HFNC |
Primary outcome
Pulmonary Complications
Time frame: 30 days
To evaluate the incidence of in-hospital pulmonary complications in 30 days in patients submitted to the use of HFNC in the perioperative period of patients undergoing thoracic surgery, when compared to the use of conventional oxygen therapy. extubation
Mortality
Time frame: 30 days
To evaluate in-hospital postoperative mortality within 30 days.
2 secondary outcomes
Incidence of hipoxemia
Time frame: 5 minuts
Complications after intubation and extubation
Time frame: 5 minuts
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Background: PubMed 30722955Nepogodiev D, Martin J, Biccard B, Makupe A, Bhangu A; National Institute for Health Research Global Health Research Unit on Global Surgery. Global burden of postoperative death. Lancet. 2019 Feb 2;393(10170):401. doi: 10.1016/S0140-6736(18)33139-8. No abstract available.
- Background: PubMed 28854536Ahmad T, Bouwman RA, Grigoras I, Aldecoa C, Hofer C, Hoeft A, Holt P, Fleisher LA, Buhre W, Pearse RM; International Surgical Outcomes Study (ISOS) group. Use of failure-to-rescue to identify international variation in postoperative care in low-, middle- and high-income countries: a 7-day cohort study of elective surgery. Br J Anaesth. 2017 Aug 1;119(2):258-266. doi: 10.1093/bja/aex185.
- Background: PubMed 25466352Serpa Neto A, Hemmes SN, Barbas CS, Beiderlinden M, Fernandez-Bustamante A, Futier E, Hollmann MW, Jaber S, Kozian A, Licker M, Lin WQ, Moine P, Scavonetto F, Schilling T, Selmo G, Severgnini P, Sprung J, Treschan T, Unzueta C, Weingarten TN, Wolthuis EK, Wrigge H, Gama de Abreu M, Pelosi P, Schultz MJ; PROVE Network investigators. Incidence of mortality and morbidity related to postoperative lung injury in patients who have undergone abdominal or thoracic surgery: a systematic review and meta-analysis. Lancet Respir Med. 2014 Dec;2(12):1007-15. doi: 10.1016/S2213-2600(14)70228-0. Epub 2014 Nov 13.
- Background: PubMed 21045639Canet J, Gallart L, Gomar C, Paluzie G, Valles J, Castillo J, Sabate S, Mazo V, Briones Z, Sanchis J; ARISCAT Group. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010 Dec;113(6):1338-50. doi: 10.1097/ALN.0b013e3181fc6e0a.
- Background: PubMed 10903604Arozullah AM, Daley J, Henderson WG, Khuri SF. Multifactorial risk index for predicting postoperative respiratory failure in men after major noncardiac surgery. The National Veterans Administration Surgical Quality Improvement Program. Ann Surg. 2000 Aug;232(2):242-53. doi: 10.1097/00000658-200008000-00015.
- Background: PubMed 26597405Meara JG, Leather AJ, Hagander L, Alkire BC, Alonso N, Ameh EA, Bickler SW, Conteh L, Dare AJ, Davies J, Merisier ED, El-Halabi S, Farmer PE, Gawande A, Gillies R, Greenberg SL, Grimes CE, Gruen RL, Ismail EA, Kamara TB, Lavy C, Lundeg G, Mkandawire NC, Raykar NP, Riesel JN, Rodas E, Rose J, Roy N, Shrime MG, Sullivan R, Verguet S, Watters D, Weiser TG, Wilson IH, Yamey G, Yip W. Global Surgery 2030: evidence and solutions for achieving health, welfare, and economic development. Int J Obstet Anesth. 2016 Feb;25:75-8. doi: 10.1016/j.ijoa.2015.09.006. Epub 2015 Sep 30. No abstract available.
- Background: PubMed 30543553Wittenstein J, Ball L, Pelosi P, Gama de Abreu M. High-flow nasal cannula oxygen therapy in patients undergoing thoracic surgery: current evidence and practice. Curr Opin Anaesthesiol. 2019 Feb;32(1):44-49. doi: 10.1097/ACO.0000000000000682.
- Background: PubMed 26969671Papazian L, Corley A, Hess D, Fraser JF, Frat JP, Guitton C, Jaber S, Maggiore SM, Nava S, Rello J, Ricard JD, Stephan F, Trisolini R, Azoulay E. Use of high-flow nasal cannula oxygenation in ICU adults: a narrative review. Intensive Care Med. 2016 Sep;42(9):1336-49. doi: 10.1007/s00134-016-4277-8. Epub 2016 Mar 11.
- Background: PubMed 32925331Spence EA, Rajaleelan W, Wong J, Chung F, Wong DT. The Effectiveness of High-Flow Nasal Oxygen During the Intraoperative Period: A Systematic Review and Meta-analysis. Anesth Analg. 2020 Oct;131(4):1102-1110. doi: 10.1213/ANE.0000000000005073.
- Background: PubMed 29330853Lodenius A, Piehl J, Ostlund A, Ullman J, Jonsson Fagerlund M. Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) vs. facemask breathing pre-oxygenation for rapid sequence induction in adults: a prospective randomised non-blinded clinical trial. Anaesthesia. 2018 May;73(5):564-571. doi: 10.1111/anae.14215. Epub 2018 Jan 13.
- Background: 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.
- Background: PubMed 28454060Brainard J, Scott BK, Sullivan BL, Fernandez-Bustamante A, Piccoli JR, Gebbink MG, Bartels K. Heated humidified high-flow nasal cannula oxygen after thoracic surgery - A randomized prospective clinical pilot trial. J Crit Care. 2017 Aug;40:225-228. doi: 10.1016/j.jcrc.2017.04.023. Epub 2017 Apr 19.
- Individual participant dataSharing planned: No
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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.
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 in people with Thoracic Surgery, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
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 1 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: status not confirmed, as of the sponsor's last update on 1 Aug 2023. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Desire Maioli (55(54)999556129, desiremaioli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary Complications (time frame: 30 days). The study lists 2 primary outcomes in all. 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 NCT05910788, which also lists 24 linked publications.
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 1 Aug 2023.