Endoscopic Sinus SurgeryNCT02692794
Large Scale Cerebral Oximetry During Sinus Endoscopy
An observational study of Endoscopic Sinus Surgery and Chronic Rhinosinusitis, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Deliberate hypotension, reverse Trendelenburg position, and hyperventilation are techniques utilized during functional endoscopic sinus surgery to attempt to reduce surgical bleeding. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Endoscopic Sinus Surgery, Chronic Rhinosinusitis
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 20 Jun 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing primary or revision endoscopic sinus surgery for chronic rhinosinusitis
Who may be able to join
- patients undergoing elective head and neck surgery at Mount Sinai Hospital in which 1) the patient will be intubated and mechanically ventilated, with 2) head of bed elevated, and in which 3) an anesthesiologist could consider deliberate hypotension as part of their management
Who cannot join
- patients under 18 years old
- patients who are currently prisoners
- patients who do not appear to have capacity to consent to the study
- patients who cannot provide informed consent in English
- pregnant women
- patients who decline to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Deliberate hypotension, reverse Trendelenburg position, and hyperventilation are techniques utilized during functional endoscopic sinus surgery to attempt to reduce surgical bleeding. These methods reduce blood flow to the head and neck area and assist in reducing bleeding during surgery but they may predispose patients to cerebral ischemia. Large scale studies necessary to conduct adequate statistical analysis regarding the effect of cerebral oximetry on otolaryngology surgery has not been extensively studied. This study seek to address the question of whether cerebral oximetry in the FESS population can help evaluate major and minor post operative morbidity, as well as the quality of recovery from surgery. Cerebral oximeters are small, noninvasive stickers applied to the forehead of participants and give the examiners data regarding the level of oxygen saturation around the brain during the course of surgery. During the course of such procedures, where blood flow to the head and neck area is intentionally decreased to assist in reducing bleeding during surgery, the levels of oxygen saturation around the brain may pose as a predictor or major and minor post operative morbidity, as well as the quality of recovery from surgery. Outcome measures will include major post operative complications, such as neurological and cardiac complications, and minor post operative morbidity, such as length of post anesthesia care unit (PACU) length of stay, nausea, and vomiting. Quality of recovery will also be assessed using a survey conducted in the PACU and again at the first post operative visit approximately one week after surgery.
Read the detailed description
Research Plan
This study will be conducted at Mount Sinai Hospital. Patients will be recruited by reading the operating room schedule in advance and contacting patients over the phone to explain the study, risks and benefits, and obtain informed consent prior to admission to the hospital.
Objective 1 The specific aim of this observational study is to evaluate changes in cerebral tissue oxygen saturation in patients undergoing head and neck surgery under general anesthesia with mechanical ventilation using the Casmed Foresight cerebral oximeter.
Ensuring patient safety in surgeries upon the head and neck is a complex task in anesthesiology. These patients present a myriad of concerns that need to be considered to create a safe and thorough anesthetic plan that include potentially difficult airways, varied patient positioning, and the intricate involvement of anesthetic drugs upon the quality of the surgical field. During common procedures such as sinus endoscopy, patients undergo endotracheal intubation and mechanical ventilation for airway protection and a strategy of deliberate hypotension is implemented with the goal of creating a clean surgical field that minimizes avoidable bleeding. The objective of this strategy is to allow the surgeons to complete their procedure more quickly and with less hypothetical risk of injury due to poor visualization of structures. However, this strategy of deliberate hypotension carries with it the potential risk of cerebral hypoperfusion as the lower limits of cerebral autoregulation are not known on an individual patient basis. Furthermore, mechanical ventilation- particularly with hyperventilation- can further decrease cerebral blood flow and potentially compromise cerebral perfusion. The current standard of care to monitor the hemodynamics of patients undergoing these procedures are standard American Society of Anesthesiologists monitors, which includes non-invasive blood pressure measurements. The investigators propose the use of a non-invasive monitor of cerebral oxygenation with cerebral oximeter probes in a prospective, observational study of a series of patients undergoing routine head and neck surgery.
- Conditions
- Endoscopic Sinus Surgery, Chronic Rhinosinusitis
- Keywords
- sinusitis, oximetry, paranasal sinus diseases
- Medical subject headings
- Sinusitis, Paranasal Sinus Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Quality of Recovery Scale
Post-operative Quality of Recovery Scale to assess cognitive delay in patients undergoing sinus surgery
Measured: Day 1- 1 hour post-operatively
Post-operative Quality of Recovery Scale
Post-operative Quality of Recovery Scale to assess cognitive delay in patients undergoing sinus surgery
Measured: Day 2
Secondary outcomes (1)
Incidence of nausea/vomiting
Increased incidence of nausea/vomiting post-operatively in patients with cerebral desaturation during the course of sinus surgery
Measured: Day 1 - 1 hour post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study startOct 2015
- Primary completion20 Jun 2016
- Study completion20 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopic Sinus SurgeryStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Satish Govindaraj, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692794
- Sponsor's protocol ID
- GCO 15-1192
- Status last verified
- Aug 2017
- First submitted
- 23 Feb 2016
- Last updated
- 10 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Large Scale Cerebral Oximetry During Sinus Endoscopy
- ClinicalTrials.gov ID
- NCT02692794
- Acronym / sponsor ID
- GCO 15-1192
- Conditions
- Endoscopic Sinus Surgery, Chronic Rhinosinusitis
- Keywords
- sinusitis, oximetry, paranasal sinus diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- 20 Jun 2016 (actual)
- Study completion
- 20 Jun 2016 (actual)
- First posted
- 26 Feb 2016 (estimated)
- 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.
Deliberate hypotension, reverse Trendelenburg position, and hyperventilation are techniques utilized during functional endoscopic sinus surgery to attempt to reduce surgical bleeding. These methods reduce blood flow to the head and neck area and assist in reducing bleeding during surgery but they may predispose patients to cerebral ischemia. Large scale studies necessary to conduct adequate statistical analysis regarding the effect of cerebral oximetry on otolaryngology surgery has not been extensively studied. This study seek to address the question of whether cerebral oximetry in the FESS population can help evaluate major and minor post operative morbidity, as well as the quality of recovery from surgery. Cerebral oximeters are small, noninvasive stickers applied to the forehead of participants and give the examiners data regarding the level of oxygen saturation around the brain during the course of surgery. During the course of such procedures, where blood flow to the head and neck area is intentionally decreased to assist in reducing bleeding during surgery, the levels of oxygen saturation around the brain may pose as a predictor or major and minor post operative morbidity, as well as the quality of recovery from surgery. Outcome measures will include major post operative complications, such as neurological and cardiac complications, and minor post operative morbidity, such as length of post anesthesia care unit (PACU) length of stay, nausea, and vomiting. Quality of recovery will also be assessed using a survey conducted in the PACU and again at the first post operative visit approximately one week after surgery.
Detailed description
Research Plan
This study will be conducted at Mount Sinai Hospital. Patients will be recruited by reading the operating room schedule in advance and contacting patients over the phone to explain the study, risks and benefits, and obtain informed consent prior to admission to the hospital.
Objective 1 The specific aim of this observational study is to evaluate changes in cerebral tissue oxygen saturation in patients undergoing head and neck surgery under general anesthesia with mechanical ventilation using the Casmed Foresight cerebral oximeter.
Ensuring patient safety in surgeries upon the head and neck is a complex task in anesthesiology. These patients present a myriad of concerns that need to be considered to create a safe and thorough anesthetic plan that include potentially difficult airways, varied patient positioning, and the intricate involvement of anesthetic drugs upon the quality of the surgical field. During common procedures such as sinus endoscopy, patients undergo endotracheal intubation and mechanical ventilation for airway protection and a strategy of deliberate hypotension is implemented with the goal of creating a clean surgical field that minimizes avoidable bleeding. The objective of this strategy is to allow the surgeons to complete their procedure more quickly and with less hypothetical risk of injury due to poor visualization of structures. However, this strategy of deliberate hypotension carries with it the potential risk of cerebral hypoperfusion as the lower limits of cerebral autoregulation are not known on an individual patient basis. Furthermore, mechanical ventilation- particularly with hyperventilation- can further decrease cerebral blood flow and potentially compromise cerebral perfusion. The current standard of care to monitor the hemodynamics of patients undergoing these procedures are standard American Society of Anesthesiologists monitors, which includes non-invasive blood pressure measurements. The investigators propose the use of a non-invasive monitor of cerebral oxygenation with cerebral oximeter probes in a prospective, observational study of a series of patients undergoing routine head and neck surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing primary or revision endoscopic sinus surgery for chronic rhinosinusitis
Key inclusion criteria (1 listed)
- patients undergoing elective head and neck surgery at Mount Sinai Hospital in which 1) the patient will be intubated and mechanically ventilated, with 2) head of bed elevated, and in which 3) an anesthesiologist could consider deliberate hypotension as part of their management
Key exclusion criteria (6 listed)
- patients under 18 years old
- patients who are currently prisoners
- patients who do not appear to have capacity to consent to the study
- patients who cannot provide informed consent in English
- pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Post-operative Quality of Recovery Scale
Time frame: Day 1- 1 hour post-operatively
Post-operative Quality of Recovery Scale to assess cognitive delay in patients undergoing sinus surgery
Post-operative Quality of Recovery Scale
Time frame: Day 2
Post-operative Quality of Recovery Scale to assess cognitive delay in patients undergoing sinus surgery
1 secondary outcome
Incidence of nausea/vomiting
Time frame: Day 1 - 1 hour post-operatively
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 10 Aug 2017.
- 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.
Satish Govindaraj, MD principal investigator
Icahn School of Medicine at Mount Sinai
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 Endoscopic Sinus Surgery and Chronic Rhinosinusitis, run by Icahn School of Medicine at Mount Sinai 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 1 inclusion and 6 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 10 Aug 2017. 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?
Post-operative Quality of Recovery Scale (time frame: Day 1- 1 hour post-operatively). 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?
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 10 Aug 2017; AzTrials last refreshed its copy on 29 Oct 2026.