Esophageal CancerNCT03816748
The Efficacy of Postoperative Application of HFNC at Acute Phase for Minimally Invasive Esophagectomy Surgery Patients
A study testing High flow nasal cannula, HFNC in people with Esophageal Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This is a prospective study that uses the treatment guideline of our chest surgery ICU. Investigators recruited 90 patients who underwent MIE in the National Taiwan University Hospital. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- High flow nasal cannula, HFNC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2019to 30 Nov 2021
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of esophageal cancer. Underwent minimally invasive esophagectomy surgery.
Who cannot join
- 1. The patient return to the intensive care unit without extubation 2. The patient who underwent tracheostomy surgery 3. Blood loss more than 1000c.c during the surgery 4. The patient who underwent CPR procedure or other emergent resuscitation management during surgery 5. The patient who is unable to communicate in words or speech
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Postoperative Application of High Flow Nasal Cannula at Acute Phase for Minimally Invasive Esophagectomy Surgery Patients
This is a prospective study that uses the treatment guideline of our chest surgery ICU. Investigators recruited 90 patients who underwent MIE in the National Taiwan University Hospital. The clinical data collected included vital signs (blood pressure, heart rate, respiratory patterns and frequencies, saturation of blood oxygen and carbon dioxide, etc.), blood tests, images and bronchoscopic analysis of sputum.
The goal of this study is to analyze common care problems and complications patients may encounter during the acute stage in ICU after MIE. By comparing the differences between the treatment group and the control group, investigators can interpret the role of HFNC.
Read the detailed description
In recent years, for resectable esophageal cancer lesions, the National Taiwan University Hospital has developed MIE from the traditional open-abdomen and open-chest reconstructive surgeries. Because the wounds of minimally invasive surgeries are smaller, most of the patients can be extubated soon in the operation rooms. During the period when the patients are sent to ICU for observation, they do not need endotracheal tubes for positive pressure or sputum suction. Thus, high standards are needed for the inspections of post-operative chest care, depth of respiration and ability of expectoration in these patients.
The HFNC used in this study can supply more than 40-60 L/min of oxygen flow, which is many times higher than the traditional nasal cannula. In addition, HFNC provides heating and moisturizing functions, so the patients 'nasal and oropharyngeal cavities do not dry out. This way, the patients can wear HFNC continuously for many days. Furthermore, when the patients close their mouths, HFNC can create a PEEP of 6-8 cmH2O, which helps with lung expansion after chest surgeries and lowers the risk of pneumonia related to lung collapses.
This is a prospective study that uses the treatment guideline of our chest surgery ICU. Investigators recruited 60 patients who underwent MIE in the National Taiwan University Hospital between January 2018 and December 2018. The clinical data collected included vital signs (blood pressure, heart rate, respiratory patterns and frequencies, saturation of blood oxygen and carbon dioxide, etc.), blood tests, images and bronchoscopic analysis of sputum.
The goal of this study is to analyze common care problems and complications patients may encounter during the acute stage in ICU after MIE. By comparing the differences between the treatment group and the control group, investigators can interpret the role of HFNC.
- Conditions
- Esophageal Cancer
- Being tested
- High flow nasal cannula, HFNC
- Keywords
- Minimally invasive surgery, High flow nasal cannula
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High flow nasal cannula, HFNCDevice
The HFNC used in this study can supply more than 40-60 L/min of oxygen flow, which is many times higher than the traditional nasal cannula. In addition, HFNC provides heating and moisturizing functions, so the patients 'nasal and oropharyngeal cavities do not dry out. This way, the patients can wear HFNC continuously for many days. Furthermore, when the patients close their mouths, HFNC can create a PEEP of 6-8 cmH2O, which helps with lung expansion after chest surgeries and lowers the risk of pneumonia related to lung collapses.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Patients who underwent minimally invasive esophagectomy surgery in our hospital and transfer to intensive care unit, and accept HFNC treatment Receives: Device: High flow nasal cannula, HFNC |
| control | No intervention | Patients who underwent minimally invasive esophagectomy surgery in our hospital and transfer to intensive care unit, and accept usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation
saturation of blood oxygen and carbon dioxide by blood gas analyzer
Measured: Post-operative 24 hours - 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start1 Jan 2019
- Primary completion30 Nov 2020
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- HSIEN-CHI LIAO, M.D., Study director, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03816748
- Sponsor's protocol ID
- 201807098RINC
- Status last verified
- May 2022
- First submitted
- 23 Jan 2019
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Postoperative Application of High Flow Nasal Cannula at Acute Phase for Minimally Invasive Esophagectomy Surgery Patients
- ClinicalTrials.gov ID
- NCT03816748
- Acronym / sponsor ID
- 201807098RINC
- Conditions
- Esophageal Cancer
- Keywords
- Minimally invasive surgery, High flow nasal cannula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 25 Jan 2019 (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.
This is a prospective study that uses the treatment guideline of our chest surgery ICU. Investigators recruited 90 patients who underwent MIE in the National Taiwan University Hospital. The clinical data collected included vital signs (blood pressure, heart rate, respiratory patterns and frequencies, saturation of blood oxygen and carbon dioxide, etc.), blood tests, images and bronchoscopic analysis of sputum.
The goal of this study is to analyze common care problems and complications patients may encounter during the acute stage in ICU after MIE. By comparing the differences between the treatment group and the control group, investigators can interpret the role of HFNC.
Detailed description
In recent years, for resectable esophageal cancer lesions, the National Taiwan University Hospital has developed MIE from the traditional open-abdomen and open-chest reconstructive surgeries. Because the wounds of minimally invasive surgeries are smaller, most of the patients can be extubated soon in the operation rooms. During the period when the patients are sent to ICU for observation, they do not need endotracheal tubes for positive pressure or sputum suction. Thus, high standards are needed for the inspections of post-operative chest care, depth of respiration and ability of expectoration in these patients.
The HFNC used in this study can supply more than 40-60 L/min of oxygen flow, which is many times higher than the traditional nasal cannula. In addition, HFNC provides heating and moisturizing functions, so the patients 'nasal and oropharyngeal cavities do not dry out. This way, the patients can wear HFNC continuously for many days. Furthermore, when the patients close their mouths, HFNC can create a PEEP of 6-8 cmH2O, which helps with lung expansion after chest surgeries and lowers the risk of pneumonia related to lung collapses.
This is a prospective study that uses the treatment guideline of our chest surgery ICU. Investigators recruited 60 patients who underwent MIE in the National Taiwan University Hospital between January 2018 and December 2018. The clinical data collected included vital signs (blood pressure, heart rate, respiratory patterns and frequencies, saturation of blood oxygen and carbon dioxide, etc.), blood tests, images and bronchoscopic analysis of sputum.
The goal of this study is to analyze common care problems and complications patients may encounter during the acute stage in ICU after MIE. By comparing the differences between the treatment group and the control group, investigators can interpret the role of HFNC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Device: High flow nasal cannula, HFNCPatients who underwent minimally invasive esophagectomy surgery in our hospital and transfer to intensive care unit, and accept HFNC treatment |
| control | No intervention | –Patients who underwent minimally invasive esophagectomy surgery in our hospital and transfer to intensive care unit, and accept usual care |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of esophageal cancer. Underwent minimally invasive esophagectomy surgery.
Key exclusion criteria (2 listed)
- 1. The patient return to the intensive care unit without extubation 2. The patient who underwent tracheostomy surgery 3. Blood loss more than 1000c.c during the surgery 4. The patient who underwent CPR procedure or other emergent resuscitation management during surgery 5. The patient who is unable to communicate in words or speech
- -
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, HFNCThe HFNC used in this study can supply more than 40-60 L/min of oxygen flow, which is many times higher than the traditional nasal cannula. In addition, HFNC provides heating and moisturizing functions, so the patients 'nasal and oropharyngeal cavities do not dry out. This way, the patients can wear HFNC continuously for many days. Furthermore, when the patients close their mouths, HFNC can create a PEEP of 6-8 cmH2O, which helps with lung expansion after chest surgeries and lowers the risk of pneumonia related to lung collapses. | Device | intervention |
Primary outcome
Oxygenation
Time frame: Post-operative 24 hours - 72 hours
saturation of blood oxygen and carbon dioxide by blood gas analyzer
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 1 Jun 2022.
- 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.
HSIEN-CHI LIAO, M.D. study director
National Taiwan University Hospital
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, HFNC in people with Esophageal Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 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 1 Jun 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 Taiwan. 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?
Oxygenation (time frame: Post-operative 24 hours - 72 hours). 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 1 Jun 2022.