Head and Neck CancerICUNCT03340038
Use of a Non-ICU Specialty Ward For Immediate Post-operative Management of Head and Neck Free Flaps
A study testing Non-ICU Specialty ward in people with Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, run by University of California, Davis at 1 site in United States.
Trial summary
Patients undergoing free flap reconstructive surgery at University of California, Davis Medical Center (UCDMC) will be assigned randomly into no intervention group (immediate post operative care in an ICU) or intervention group (immediate post operative care in a non-ICU specialty ward). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Head and Neck Carcinoma
- What is being tested?
- Non-ICU Specialty ward
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2016to 16 Apr 2019
- 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
- Patients undergoing free flaps for reconstruction of head and neck surgical defects at UCDMC, including but not limited to, head and neck cancer defects, osteoradionecrosis (ORN), and trauma
- 18 years of age and older and able to consent
Who cannot join
- Vulnerable populations: adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, and prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis
Sacramento, California, 95817
About this study
Official title: Use of a Non-ICU Specialty Ward For Immediate Post-operative Management of Head and Neck Free Flaps: A Randomized Controlled Trial
Patients undergoing free flap reconstructive surgery at University of California, Davis Medical Center (UCDMC) will be assigned randomly into no intervention group (immediate post operative care in an ICU) or intervention group (immediate post operative care in a non-ICU specialty ward). The investigators hypothesize that there is no significant difference in the length of stay (LOS) or complication rate between head and neck free flaps patients managed immediately post-operatively in an ICU versus a non-ICU specialty ward. The primary objective is to compare the postoperative LOS between head and neck free-flap patients managed initially in an ICU versus a non-ICU specialty ward. The secondary objective is to compare differences in the rate of complications between head and neck free flap patients managed initially in an ICU versus a non-ICU specialty ward. Finally, the tertiary objective is to compare differences in resource utilization between head and neck free-flap patients managed initially in an ICU versus a non-ICU specialty ward.
Read the detailed description
Free flaps are an instrumental component of head and neck reconstructive surgery. There is no current consensus on the postoperative management of these patients despite the increasing frequency with which free flaps are used. Although patients often do not have a specific medical indication for postoperative ICU management, they frequently are sent to the ICU for postoperative care based on the need for close nurse monitoring of the flap. In a US based survey in 2007, 88.9% of head and neck surgeons were sending postoperative flap patients to the ICU. Typical ICU length of stay for these patients varies from 2-11 days. There are numerous theoretic disadvantages to ICU care in these patients. ICU care has been associated with increased use of sedation leading to decreased flap perfusion, prolonged use of ventilation, less self care, less ambulation, increased delirium and increased cost.
Due to these concerns, several institutions have developed protocols that allow for the monitoring of head and neck free-flap patients outside of the ICU. Two recent retrospective studies assessed outcomes using these protocols, including 257 patients (119 ICU, 138 ward) and showed no significant difference in morbidity and mortality, or flap failure between the groups. There was a significant increase LOS from 8 to 9 days and transfusion rate, in the ICU group. Another study looked at 247 patients (175 ICU, 72 ward) and found no difference between flap failure, reoperation, hematoma, wound complications between the groups. They also found an increased LOS from 7 to 8 days in the ICU group. They calculated cost difference and found a decrease in average patient cost from $101,199 to $86,195 in the ward group. These studies support the use of non-ICU care for head and neck free-flap patients, however given their retrospective nature significant biases may exist, tempering the strength of their conclusions. To date, there has never been a Randomized Controlled Trial (RCT) that addresses this question.
This is a non-inferiority RCT at UCDMC to assess differences in LOS, complication rate and resource utilization between patients randomized to the ICU and a head and neck specialty ward. Since ICU/Ward bed availability has to be determined before surgery, a subject will be randomized before surgery when the subject meets all inclusion and none of the exclusion criteria. Currently, postoperative flap patients who are not enrolled in the study at UCDMC are monitored in the ICU for a minimum of 24 hours following their surgery.
- Conditions
- Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Head and Neck Carcinoma, Trauma
- Being tested
- Non-ICU Specialty ward
- Keywords
- Free Flap Reconstructive Surgery, Head and Neck
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-ICU Specialty wardOther
| Study group | Role | What they receive |
|---|---|---|
| Specialty Ward | Active comparator | Patients who have been randomized into receiving post-operative care at the Non-ICU Specialty ward (intervention) after receiving flap reconstructive surgery on their mucosal or cutaneous defect. Receives: Other: Non-ICU Specialty ward |
| Intensive Care Unit (ICU) | No intervention | Patients who have been randomized into receiving post-operative care at the intensive care unit after receiving flap reconstructive surgery on their mucosal or cutaneous defect. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Stay
Number of days
Measured: 30 days
Secondary outcomes (1)
Inpatient Hospital Costs (dollar amounts)
Total inpatient hospital cost, insurance adjustments, and payments
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start10 Apr 2016
- Primary completion11 Feb 2019
- Study completion16 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arnaud Bewley, University of California, Davis
- Investigators
- Arnaud Bewley, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03340038
- Sponsor's protocol ID
- 841511
- Acronym
- ICU
- Status last verified
- Oct 2019
- First submitted
- 8 Nov 2017
- Last updated
- 29 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Non-ICU Specialty Ward For Immediate Post-operative Management of Head and Neck Free Flaps: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03340038
- Acronym / sponsor ID
- ICU / 841511
- Conditions
- Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Head and Neck Carcinoma, Trauma
- Keywords
- Free Flap Reconstructive Surgery, Head and Neck
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 10 Apr 2016 (actual)
- Primary completion
- 11 Feb 2019 (actual)
- Study completion
- 16 Apr 2019 (actual)
- First posted
- 13 Nov 2017 (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.
Patients undergoing free flap reconstructive surgery at University of California, Davis Medical Center (UCDMC) will be assigned randomly into no intervention group (immediate post operative care in an ICU) or intervention group (immediate post operative care in a non-ICU specialty ward). The investigators hypothesize that there is no significant difference in the length of stay (LOS) or complication rate between head and neck free flaps patients managed immediately post-operatively in an ICU versus a non-ICU specialty ward. The primary objective is to compare the postoperative LOS between head and neck free-flap patients managed initially in an ICU versus a non-ICU specialty ward. The secondary objective is to compare differences in the rate of complications between head and neck free flap patients managed initially in an ICU versus a non-ICU specialty ward. Finally, the tertiary objective is to compare differences in resource utilization between head and neck free-flap patients managed initially in an ICU versus a non-ICU specialty ward.
Detailed description
Free flaps are an instrumental component of head and neck reconstructive surgery. There is no current consensus on the postoperative management of these patients despite the increasing frequency with which free flaps are used. Although patients often do not have a specific medical indication for postoperative ICU management, they frequently are sent to the ICU for postoperative care based on the need for close nurse monitoring of the flap. In a US based survey in 2007, 88.9% of head and neck surgeons were sending postoperative flap patients to the ICU. Typical ICU length of stay for these patients varies from 2-11 days. There are numerous theoretic disadvantages to ICU care in these patients. ICU care has been associated with increased use of sedation leading to decreased flap perfusion, prolonged use of ventilation, less self care, less ambulation, increased delirium and increased cost.
Due to these concerns, several institutions have developed protocols that allow for the monitoring of head and neck free-flap patients outside of the ICU. Two recent retrospective studies assessed outcomes using these protocols, including 257 patients (119 ICU, 138 ward) and showed no significant difference in morbidity and mortality, or flap failure between the groups. There was a significant increase LOS from 8 to 9 days and transfusion rate, in the ICU group. Another study looked at 247 patients (175 ICU, 72 ward) and found no difference between flap failure, reoperation, hematoma, wound complications between the groups. They also found an increased LOS from 7 to 8 days in the ICU group. They calculated cost difference and found a decrease in average patient cost from $101,199 to $86,195 in the ward group. These studies support the use of non-ICU care for head and neck free-flap patients, however given their retrospective nature significant biases may exist, tempering the strength of their conclusions. To date, there has never been a Randomized Controlled Trial (RCT) that addresses this question.
This is a non-inferiority RCT at UCDMC to assess differences in LOS, complication rate and resource utilization between patients randomized to the ICU and a head and neck specialty ward. Since ICU/Ward bed availability has to be determined before surgery, a subject will be randomized before surgery when the subject meets all inclusion and none of the exclusion criteria. Currently, postoperative flap patients who are not enrolled in the study at UCDMC are monitored in the ICU for a minimum of 24 hours following their surgery.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Specialty Ward | Active comparator | Other: Non-ICU Specialty wardPatients who have been randomized into receiving post-operative care at the Non-ICU Specialty ward (intervention) after receiving flap reconstructive surgery on their mucosal or cutaneous defect. |
| Intensive Care Unit (ICU) | No intervention | –Patients who have been randomized into receiving post-operative care at the intensive care unit after receiving flap reconstructive surgery on their mucosal or cutaneous defect. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing free flaps for reconstruction of head and neck surgical defects at UCDMC, including but not limited to, head and neck cancer defects, osteoradionecrosis (ORN), and trauma
- 18 years of age and older and able to consent
Key exclusion criteria (1 listed)
- Vulnerable populations: adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, and prisoners
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 |
|---|---|---|
| Non-ICU Specialty ward | Other | Specialty Ward |
Primary outcome
Length of Stay
Time frame: 30 days
Number of days
1 secondary outcome
Inpatient Hospital Costs (dollar amounts)
Time frame: 30 days
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 29 Oct 2019.
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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.
Arnaud Bewley, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-ICU Specialty ward in people with Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, run by University of California, Davis at 1 site in United States.
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 2 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: finished, as of the sponsor's last update on 29 Oct 2019. 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 States. 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?
Length of Stay (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 29 Oct 2019.