Cancer of the EsophagusHi-FLONCT04272268
Feasibility and Safety of Using Nasal High Flow Oxygen Postoperatively to Reduce Respiratory Complications
An observational study of Cancer of the Esophagus, run by University Hospitals of North Midlands NHS Trust at 1 site in United Kingdom.
Trial summary
The use of nasal high flow in patients undergoing oesophagectomy is a novel technique that has not been previously studied. Nasal high flow will be delivered postoperatively to patients undergoing oesophagectomy in a tertiary cancer referral centre. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of the Esophagus
- What is being tested?
- Nasal High flow Oxygen
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2019to 31 Mar 2020
- Phase
- Observational
- 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
Study population: Nasal high flow will be delivered postoperatively to patients undergoing oesophagectomy in a tertiary cancer referral centre. This single-centre cohort study will evaluate the safety of using nasal high flow in oesophagectomy patients.
Who may be able to join
- Over 18 years old
- Undergoing Ivor-Lewis (2-stage) oesophagectomy
- Successfully extubated within 4 hours after surgery
Who cannot join
- History of bullous emphysematous disease
- Lack of capacity to consent
- Significant air leak during surgery
- Incurable disease found at surgery leading to no surgical resection
- Failure of extubation and spontaneous breathing within 4 hours after surgery
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Robert James Bowler
Stoke-on-Trent, Staffordshire, ST44JJ
About this study
Official title: Evaluating the Feasibility and Safety of Using Nasal High Flow Oxygen for Five Days Postoperatively to Reduce Respiratory Complications After Oesophagectomy for Cancer
The use of nasal high flow in patients undergoing oesophagectomy is a novel technique that has not been previously studied.
Nasal high flow will be delivered postoperatively to patients undergoing oesophagectomy in a tertiary cancer referral centre. This single-centre cohort study will evaluate the safety of using nasal high flow in oesophagectomy patients. Physiological parameters, adverse events and clinical outcome will be recorded in consecutive patients undergoing oesophagogastric surgery.
This study will challenge the hypothesis that the use of nasal high-flow will lower the rates of breathing complications such as pneumonia thereby reducing the demands on intensive care, shortening hospital stay and improving patient quality of life. The results will inform the design of a larger multicentre clinical trial comparing nasal high flow to conventional methods by facilitating sample size calculation.
Read the detailed description
Respiratory complications including pneumonia, pleural effusion, adult respiratory distress syndrome and pulmonary embolism will be recorded. The primary endpoint will be the rate of postoperative respiratory complications within 30 days of oesophagectomy. Technical complications related to nasal high flow administration will be recorded and reasons for discontinuing nasal high flow documented. Other outcome including mortality, hospital stay, surgical complications and respiratory complications within 90 days of surgery will be considered as secondary endpoints. These data will assess the feasibility and safety of using nasal high flow in patients undergoing oesophagectomy. The rate of respiratory complications will be determined in a cohort of consecutive surgical patients together with other measures of outcome to form the basis of a series worthy of reporting. This may help gain insight into whether using nasal high flow could benefit patients, and whether further research to compare nasal high flow to conventional respiratory support would be of value.
- Conditions
- Cancer of the Esophagus
- Being tested
- Nasal High flow Oxygen
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal High flow OxygenDevice
If the patient is successfully extubated within 4 hours following surgery and meets the post surgery inclusion/exclusion criteria, Nasal high flow oxygen will be administered continuously using a humidifier machine for 5 days. Breathing circuits and nasal cannulae will be connected to the machine to deliver oxygen at 20L/min to the patient.
| Study group | Role | What they receive |
|---|---|---|
| Nasal High flow Oxygen | Following consent, the participant will undergo Oesophagectomy as per routine care. During surgery, prior to trial participation and as per standard of care at the site, a nasogastric tube will be placed into the gastric conduit and secured to the nose. This tube will be left on free drainage and aspirated every 4 hours to check for inadvertent insufflation. Receives: Device: Nasal High flow Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of respiratory complications within 30 days after surgery
including pneumonia, pleural effusion, adult respiratory distress syndrome and pulmonary embolism.
Measured: 30 days
Secondary outcomes (6)
30 day mortality
Measured: 30 days
90 day mortality
Measured: 90 days
90 day respiratory complication rate
Measured: 90 days
The proportion of blood gases performed on time
Measured: 5 days
The proportion of missing results
Measured: 5 days
Recruitment rate
To facilitate sample size calculation for such a randomized controlled trial.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start1 Oct 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Why it stopped: Covid-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of the EsophagusStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals of North Midlands NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerorge Bouras, Principal investigator, University Hospitals of North Midlands NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04272268
- Sponsor's protocol ID
- 2063
- Other IDs
- 214643
- Acronym
- Hi-FLO
- Status last verified
- Dec 2023
- First submitted
- 14 Feb 2020
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility and Safety of Using Nasal High Flow Oxygen for Five Days Postoperatively to Reduce Respiratory Complications After Oesophagectomy for Cancer
- ClinicalTrials.gov ID
- NCT04272268
- Acronym / sponsor ID
- Hi-FLO / 2063
- Conditions
- Cancer of the Esophagus
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Covid-19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospitals of North Midlands NHS TrustUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 17 Feb 2020 (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 use of nasal high flow in patients undergoing oesophagectomy is a novel technique that has not been previously studied.
Nasal high flow will be delivered postoperatively to patients undergoing oesophagectomy in a tertiary cancer referral centre. This single-centre cohort study will evaluate the safety of using nasal high flow in oesophagectomy patients. Physiological parameters, adverse events and clinical outcome will be recorded in consecutive patients undergoing oesophagogastric surgery.
This study will challenge the hypothesis that the use of nasal high-flow will lower the rates of breathing complications such as pneumonia thereby reducing the demands on intensive care, shortening hospital stay and improving patient quality of life. The results will inform the design of a larger multicentre clinical trial comparing nasal high flow to conventional methods by facilitating sample size calculation.
Detailed description
Respiratory complications including pneumonia, pleural effusion, adult respiratory distress syndrome and pulmonary embolism will be recorded. The primary endpoint will be the rate of postoperative respiratory complications within 30 days of oesophagectomy. Technical complications related to nasal high flow administration will be recorded and reasons for discontinuing nasal high flow documented. Other outcome including mortality, hospital stay, surgical complications and respiratory complications within 90 days of surgery will be considered as secondary endpoints. These data will assess the feasibility and safety of using nasal high flow in patients undergoing oesophagectomy. The rate of respiratory complications will be determined in a cohort of consecutive surgical patients together with other measures of outcome to form the basis of a series worthy of reporting. This may help gain insight into whether using nasal high flow could benefit patients, and whether further research to compare nasal high flow to conventional respiratory support would be of value.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nasal High flow Oxygen | – | Device: Nasal High flow OxygenFollowing consent, the participant will undergo Oesophagectomy as per routine care. During surgery, prior to trial participation and as per standard of care at the site, a nasogastric tube will be placed into the gastric conduit and secured to the nose. This tube will be left on free drainage and aspirated every 4 hours to check for inadvertent insufflation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Nasal high flow will be delivered postoperatively to patients undergoing oesophagectomy in a tertiary cancer referral centre. This single-centre cohort study will evaluate the safety of using nasal high flow in oesophagectomy patients.
Key inclusion criteria (3 listed)
- Over 18 years old
- Undergoing Ivor-Lewis (2-stage) oesophagectomy
- Successfully extubated within 4 hours after surgery
Key exclusion criteria (5 listed)
- History of bullous emphysematous disease
- Lack of capacity to consent
- Significant air leak during surgery
- Incurable disease found at surgery leading to no surgical resection
- Failure of extubation and spontaneous breathing within 4 hours after surgery
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 |
|---|---|---|
| Nasal High flow OxygenIf the patient is successfully extubated within 4 hours following surgery and meets the post surgery inclusion/exclusion criteria, Nasal high flow oxygen will be administered continuously using a humidifier machine for 5 days. Breathing circuits and nasal cannulae will be connected to the machine to deliver oxygen at 20L/min to the patient. | Device | Nasal High flow Oxygen |
Primary outcome
Rate of respiratory complications within 30 days after surgery
Time frame: 30 days
including pneumonia, pleural effusion, adult respiratory distress syndrome and pulmonary embolism.
6 secondary outcomes
30 day mortality
Time frame: 30 days
90 day mortality
Time frame: 90 days
90 day respiratory complication rate
Time frame: 90 days
The proportion of blood gases performed on time
Time frame: 5 days
The proportion of missing results
Time frame: 5 days
Recruitment rate
Time frame: 90 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- 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.
Gerorge Bouras principal investigator
University Hospitals of North Midlands NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer of the Esophagus, run by University Hospitals of North Midlands NHS Trust at 1 site in United Kingdom.
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 3 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: withdrawn, as of the sponsor's last update on 15 Apr 2024. 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 Kingdom. 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 was withdrawn before enrolling participants, so there are no results.
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?
Rate of respiratory complications within 30 days after surgery (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 15 Apr 2024.