Pulmonary ResectionNCT05511636
Comparing The Outcome Of High Flow Oxygen Versus Conventional Oxygen In Extubated Patients After Lung Resection.
A study testing Oxygen therapy in people with Pulmonary Resection and Oxygen Therapy, run by Ain Shams University at 1 site in Egypt.
Trial summary
Conventional oxygen therapy (COT) is the main supportive treatment administered to patients postoperative after planned extubation and has conventionally been delivered using nasal prongs, cannula or masks. However, the maximal oxygen flow rates that these devices can deliver are limited. Read more about this study
- Who is it for?
- Ages 10 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Resection, Oxygen Therapy
- What is being tested?
- Oxygen therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 1 Dec 2023
- 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 10 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- • Patients undergoing elective lung resection, including lobectomy, wedge resection, segmentectomy, metastasectomy; open thoracotomy or video-assisted thoracoscopic surgery (VATS)
Who cannot join
- • Age below 10 years and above 80 years, as this age range was the age in the 2 pervious studies in literature.
- Immunocompromised patients.
- Pregnant females.
- Patients with history of obstructive sleep apnea.
- Tracheostomized patients.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ainshams University Hospitals
Cairo, 11511
ahmed m. mostafa, professor, +201008603824, abdelfatah_abugabal@hotmail.com
About this study
Official title: A Randomized Controlled Trial To Compare The Outcome Of High Flow Oxygen Versus Conventional Oxygen In Extubated Patients After Lung Resection.
Conventional oxygen therapy (COT) is the main supportive treatment administered to patients postoperative after planned extubation and has conventionally been delivered using nasal prongs, cannula or masks. However, the maximal oxygen flow rates that these devices can deliver are limited. Being diluted by the ambient air which reduces the fraction of inspired oxygen is not only the main concern, but also COT is difficult to meet the requirements of heating and humidification in extubated patients. Yu Y, et al. (2017)
High-flow nasal cannula (HFNC) can supply a mixture of air and oxygen via a heated and humidified circuit at a very high flow. It can provide almost pure oxygen with a FiO2 of approximately 100% and a maximal flow rate up to 60 L/min. The use of a HFNC may generate a positive airway pressure, ameliorate oxygenation and dyspnea, reduce the respiratory rate and work of breathing, and improve comfort. Yu Y, et al. (2017)
Few studies were conducted in the past 5 years; and the effect of HFNC therapy compared to COT in patients after planned extubation remains inconclusive. This study will be done to compare the usage of HFNC as an alternative to the conventional oxygen therapy following extubation for patients undergoing pulmonary resection. Youfeng Zhu, et al. (2019)
Read the detailed description
Postoperative interventions effective in the reduction of pulmonary complications include good pain control, incentive spirometry, oxygen therapy, intermittent continuous positive airway pressure (CPAP), and early mobilization. Simple techniques such as incentive spirometry and patient positioning have proven to be ineffective in countering atelectasis, which can occur postoperatively in as many as 90% of patients. Noninvasive ventilatory support in the form of CPAP has been used as both a prophylactic and therapeutic intervention to improve ventilation in postoperative patients. Although CPAP may prevent pulmonary complications, it is uncomfortable for patients because it is applied by a tight-fitting mask, and patients may complain of difficulty with communication, eating and drinking, and mobilization, and consequently compliance is often poor. Bilal M. Ansari, et al. (2016)
Conventional oxygen therapy via nasal prongs or a facemask can supplement oxygen administration, in some of the patients specially those who have lobectomy, it is ineffective in compensating for loss in lung volume or in maintaining gas exchange. High-flow nasal cannula oxygen (HFNC) mainly delivers a flow-dependent positive airway pressure and improves oxygenation by increasing end-expiratory lung volume. It is considered to have a number of physiological advantages compared with other standard oxygen therapies, including the provision of positive end-expiratory pressure (PEEP), constant FiO2, and good humidification. More importantly, it can reduce the anatomical dead space. Youfeng Zhu, et al. (2019)
HFNC can be widely employed for patients of all age groups in several types of respiratory failure from preterm infants to adults and is broadly used in ICU because of the ease of use, tolerability, and safety. Youfeng Zhu, et al. (2019) HFNC systems now are increasingly being utilized, as when compared to regular nasal cannula and facemask oxygen, HFNC appears to be linked to decreased level of respiratory complications and hypoxemia after lung resection. Yu Y, et al. (2017)
Few studies were conducted comparing different modalities of oxygen therapy; however, the answer of this question is still controversial. Is HFNC should be used as an alternative to the conventional oxygen therapy for patients undergoing lung resection following extubation ?
- Conditions
- Pulmonary Resection, Oxygen Therapy
- Being tested
- Oxygen therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen therapyOther
Also called oxygen
This study will be conducted on 180 patients who will be undergoing lung resection (wedge resection, segmentectomy, metastasectomy, lobectomy, or pneumonectomy) surgery at the Cardiothoracic department, Ain Shams University Hospitals; patients are to be extubated intraoperative, and at the ICU we will be comparing HFNC to standard oxygen therapy. The endpoints of the study are to investigate whether high-flow nasal cannula oxygen therapy is superior to conventional oxygen therapy for reducing hypoxemia and postoperative pulmonary complications in extubated patients after lung resection.
| Study group | Role | What they receive |
|---|---|---|
| those that receive the conventional oxygen | Experimental | This study will be conducted on 180 patients who will be undergoing lung resection (wedge resection, segmentectomy, metastasectomy, lobectomy, or pneumonectomy) surgery at the Cardiothoracic department, Ain Shams University Hospitals; patients are to be extubated intraoperative, and at the ICU will be given HFNC . The endpoints of the study are to investigate whether high-flow nasal cannula oxygen therapy is superior to conventional oxygen therapy for reducing hypoxemia and postoperative pulmonary complications in extubated patients after lung resection. Receives: Other: Oxygen therapy |
| those that receive the high flow oxygen therapy. | Experimental | This study will be conducted on 180 patients who will be undergoing lung resection (wedge resection, segmentectomy, metastasectomy, lobectomy, or pneumonectomy) surgery at the Cardiothoracic department, Ain Shams University Hospitals; patients are to be extubated intraoperative, and at the ICU will be given standard oxygen therapy . The endpoints of the study are to investigate whether high-flow nasal cannula oxygen therapy is superior to conventional oxygen therapy for reducing hypoxemia and postoperative pulmonary complications in extubated patients after lung resection. Receives: Other: Oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
HFNC is superior to conventional oxygen for reducing hypoxemia [arterial partial pressure of oxygen/fraction of inspired oxygen] < 300) and postoperative pulmonary complications occurring within 30 days in extubated patients after lung resection.
patients were extubated intraoperative, and at the ICU we compared HFNC to standard oxygen therapy. Postoperative pulmonary function expressed as ppoFEV1 (predicted postoperative forced expiratory volume in one second) was prognosticated preoperatively using spirometry. Oxygen therapy was delivered for at least 48 hours, and if any patient needed more time on oxygen therapy; it was maintained and patients were allowed to be transferred from control group to study group if needed, but didn't happen.
HFNC oxygen therapy group (HFNCG) received a flow rate of 35 to 60 L/min and FiO2 was titrated (from 45% to 100%) by the treating clinician to maintain a peripheral oxygen saturation (SpO2) of 95% or more. The conventional oxygen therapy group (COG) received oxygen via either nasal prongs or facemask with oxygen flow titrated by the bedside clinician to maintain a SpO2 of 92% or more.
Measured: 120 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start1 Jan 2019
- Primary completion20 Aug 2022
- Study completion1 Dec 2023 (estimated)
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 Pulmonary ResectionStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ahmed t. hussain kamel, MSC, Principal investigator, ainshams uU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511636
- Sponsor's protocol ID
- Cardiothoracic academy
- Status last verified
- Aug 2022
- First submitted
- 5 Jul 2022
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Yes
Publications
Yu 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 28298878
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial To Compare The Outcome Of High Flow Oxygen Versus Conventional Oxygen In Extubated Patients After Lung Resection.
- ClinicalTrials.gov ID
- NCT05511636
- Acronym / sponsor ID
- Cardiothoracic academy
- Conditions
- Pulmonary Resection, Oxygen Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 20 Aug 2022 (actual)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 23 Aug 2022 (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.
Conventional oxygen therapy (COT) is the main supportive treatment administered to patients postoperative after planned extubation and has conventionally been delivered using nasal prongs, cannula or masks. However, the maximal oxygen flow rates that these devices can deliver are limited. Being diluted by the ambient air which reduces the fraction of inspired oxygen is not only the main concern, but also COT is difficult to meet the requirements of heating and humidification in extubated patients. Yu Y, et al. (2017)
High-flow nasal cannula (HFNC) can supply a mixture of air and oxygen via a heated and humidified circuit at a very high flow. It can provide almost pure oxygen with a FiO2 of approximately 100% and a maximal flow rate up to 60 L/min. The use of a HFNC may generate a positive airway pressure, ameliorate oxygenation and dyspnea, reduce the respiratory rate and work of breathing, and improve comfort. Yu Y, et al. (2017)
Few studies were conducted in the past 5 years; and the effect of HFNC therapy compared to COT in patients after planned extubation remains inconclusive. This study will be done to compare the usage of HFNC as an alternative to the conventional oxygen therapy following extubation for patients undergoing pulmonary resection. Youfeng Zhu, et al. (2019)
Detailed description
Postoperative interventions effective in the reduction of pulmonary complications include good pain control, incentive spirometry, oxygen therapy, intermittent continuous positive airway pressure (CPAP), and early mobilization. Simple techniques such as incentive spirometry and patient positioning have proven to be ineffective in countering atelectasis, which can occur postoperatively in as many as 90% of patients. Noninvasive ventilatory support in the form of CPAP has been used as both a prophylactic and therapeutic intervention to improve ventilation in postoperative patients. Although CPAP may prevent pulmonary complications, it is uncomfortable for patients because it is applied by a tight-fitting mask, and patients may complain of difficulty with communication, eating and drinking, and mobilization, and consequently compliance is often poor. Bilal M. Ansari, et al. (2016)
Conventional oxygen therapy via nasal prongs or a facemask can supplement oxygen administration, in some of the patients specially those who have lobectomy, it is ineffective in compensating for loss in lung volume or in maintaining gas exchange. High-flow nasal cannula oxygen (HFNC) mainly delivers a flow-dependent positive airway pressure and improves oxygenation by increasing end-expiratory lung volume. It is considered to have a number of physiological advantages compared with other standard oxygen therapies, including the provision of positive end-expiratory pressure (PEEP), constant FiO2, and good humidification. More importantly, it can reduce the anatomical dead space. Youfeng Zhu, et al. (2019)
HFNC can be widely employed for patients of all age groups in several types of respiratory failure from preterm infants to adults and is broadly used in ICU because of the ease of use, tolerability, and safety. Youfeng Zhu, et al. (2019) HFNC systems now are increasingly being utilized, as when compared to regular nasal cannula and facemask oxygen, HFNC appears to be linked to decreased level of respiratory complications and hypoxemia after lung resection. Yu Y, et al. (2017)
Few studies were conducted comparing different modalities of oxygen therapy; however, the answer of this question is still controversial. Is HFNC should be used as an alternative to the conventional oxygen therapy for patients undergoing lung resection following extubation ?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| those that receive the conventional oxygen | Experimental | Other: Oxygen therapyThis study will be conducted on 180 patients who will be undergoing lung resection (wedge resection, segmentectomy, metastasectomy, lobectomy, or pneumonectomy) surgery at the Cardiothoracic department, Ain Shams University Hospitals; patients are to be extubated intraoperative, and at the ICU will be given HFNC . The endpoints of the study are to investigate whether high-flow nasal cannula oxygen therapy is superior to conventional oxygen therapy for reducing hypoxemia and postoperative pulmonary complications in extubated patients after lung resection. |
| those that receive the high flow oxygen therapy. | Experimental | Other: Oxygen therapyThis study will be conducted on 180 patients who will be undergoing lung resection (wedge resection, segmentectomy, metastasectomy, lobectomy, or pneumonectomy) surgery at the Cardiothoracic department, Ain Shams University Hospitals; patients are to be extubated intraoperative, and at the ICU will be given standard oxygen therapy . The endpoints of the study are to investigate whether high-flow nasal cannula oxygen therapy is superior to conventional oxygen therapy for reducing hypoxemia and postoperative pulmonary complications in extubated patients after lung resection. |
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- • Patients undergoing elective lung resection, including lobectomy, wedge resection, segmentectomy, metastasectomy; open thoracotomy or video-assisted thoracoscopic surgery (VATS)
Key exclusion criteria (5 listed)
- • Age below 10 years and above 80 years, as this age range was the age in the 2 pervious studies in literature.
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 |
|---|---|---|
| Oxygen therapyAlso: oxygenThis study will be conducted on 180 patients who will be undergoing lung resection (wedge resection, segmentectomy, metastasectomy, lobectomy, or pneumonectomy) surgery at the Cardiothoracic department, Ain Shams University Hospitals; patients are to be extubated intraoperative, and at the ICU we will be comparing HFNC to standard oxygen therapy. The endpoints of the study are to investigate whether high-flow nasal cannula oxygen therapy is superior to conventional oxygen therapy for reducing hypoxemia and postoperative pulmonary complications in extubated patients after lung resection. | Other | those that receive the conventional oxygen, those that receive the high flow oxygen therapy. |
Primary outcome
HFNC is superior to conventional oxygen for reducing hypoxemia [arterial partial pressure of oxygen/fraction of inspired oxygen] < 300) and postoperative pulmonary complications occurring within 30 days in extubated patients after lung resection.
Time frame: 120 weeks
patients were extubated intraoperative, and at the ICU we compared HFNC to standard oxygen therapy. Postoperative pulmonary function expressed as ppoFEV1 (predicted postoperative forced expiratory volume in one second) was prognosticated preoperatively using spirometry. Oxygen therapy was delivered for at least 48 hours, and if any patient needed more time on oxygen therapy; it was maintained and patients were allowed to be transferred from control group to study group if needed, but didn't happen. HFNC oxygen therapy group (HFNCG) received a flow rate of 35 to 60 L/min and FiO2 was titrated (from 45% to 100%) by the treating clinician to maintain a peripheral oxygen saturation (SpO2) of 95% or more. The conventional oxygen therapy group (COG) received oxygen via either nasal prongs or facemask with oxygen flow titrated by the bedside clinician to maintain a SpO2 of 92% or more.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Background: PubMed 28298878Yu 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.
- Individual participant dataSharing planned: Undecided. Yes
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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.
ahmed t. hussain kamel, MSC principal investigator
ainshams uU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen therapy in people with Pulmonary Resection and Oxygen Therapy, run by Ain Shams University at 1 site in Egypt.
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 5 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 23 Aug 2022. 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 Egypt. 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 Ahmed T. Hussain kamel, MSC (+201227878059, Dr.ath@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HFNC is superior to conventional oxygen for reducing hypoxemia [arterial partial pressure of oxygen/fraction of inspired oxygen] < 300) and postoperative pulmonary complications occurring within 30 days in extubated patients after lung resection. (time frame: 120 weeks). 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 NCT05511636, 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 23 Aug 2022.