Large Scale Cerebral Oximetry During Sinus Endoscopy
| Status: | Recruiting |
|---|---|
| Conditions: | Sinusitis |
| Therapuetic Areas: | Otolaryngology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/23/2016 |
| Start Date: | October 2015 |
| End Date: | June 2017 |
| Contact: | Mohemmed Khan, MD |
| Email: | mohemmed.khan@mountsinai.org |
| Phone: | 201-707-2016 |
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.
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.
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
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