Sleep Apnea, Obstructive
Conditions
Keywords
Obstructive Sleep Apnea, Pulse Oximetry
Brief summary
Patients with Obstructive Sleep Apnea (OSA) have cyclical patterns of lower blood oxygen during sleep because of repeated episodes of upper airway obstruction that cause their breathing to stop. When these patients have surgery, anesthetic drugs may worsen these patterns of lower blood oxygen. This study monitors ten patients at high risk for OSA and ten patients at low risk for OSA during surgery. Patterns of lower oxygen saturations should arise in the high risk group but not the low risk group.
Detailed description
Patients with Obstructive Sleep Apnea (OSA) have episodes of upper airway obstruction during sleep which have been shown to be accompanied by multiple oxygen desaturations followed by short recovery intervals until rising PaCO2 causes sleep disruption/rescue arousal. In the postoperative and conscious sedation arena, these patterns can deteriorate from a stable pattern to a severely unstable pattern which may go unrecognized and lead to an adverse event (respiratory/cardiac arrest; death). Anesthesia and the higher consumption of analgesics produce a profound reduction in pharyngeal tone, a dampening of both chemoreceptor sensitivity and arousal/rescue response. Thus the first 48 hours post operatively presents a vulnerable period. Respiratory disturbances are more prominent - respiratory arrest and hypopnea being the main adverse occurrences during this period. An algorithm has been developed that monitors saturation and indicates repetitive reductions in airflow through the upper airway and into the lungs. Presence of this pattern in the procedural sedation patient population has not been tested for its prevalence. This study will monitor patients during surgery to determine if this pattern occurs in this hospital setting.
Interventions
None listed
Sponsors
Medtronic - MITG
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age greater than 21 years * Patients scheduled for a procedure that requires analgesia and/or sedation by any route (intravenous, intramuscular, oral, epidural or intrathecal). * Patients with an anticipated length of sedation greater than or equal to one hour. * Patients in the ASA category I through III. * Patients who only receive propofol, benzodiazepines, and opioids.
Exclusion criteria
* Age less than 21 years * Patients whose room air oxygen saturation is \<90% * Patients receiving post-operative positive airway pressure support * Previous allergic/contact reactions to adhesives * CHF * Moderate or severe valvular disease * TIA/CVA * Carotid stenosis or endarterectomy * Anemia (HCT if available \< 30%) * Pulmonary hypertension * Dialysis * Pregnancy * Patients unable to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Saturation Pattern Detection (SPD) Indicative of Repetitive Reductions in Air Flow | 3 hours | Saturation Pattern Detection (SPD) is the pattern of oxygen saturation values plotted against time that occurs when patients have cyclical reduced air movement during breathing. Their blood oxygen level decreases and increases as they slow and increase their breathing. |
| Number of Participants Requiring Airway Support | 3 hours | Drugs during surgery may cause the throat to relax and block breathing. To treat this, the caregiver administers airway support. Airway support is moving the jaw forward, inserting a plastic tube (nasal-oral airway) or applying a mask with positive pressure. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from July through November 2009 in the medical clinic who were scheduled for surgery that required procedural sedation.
Participants by arm
| Arm | Count |
|---|---|
| Obstructive Sleep Apnea Surgery patients at high risk for Obstructive Sleep Apnea | 11 |
| Surgery Patients Surgery patients at low risk for Obstructive Sleep Apnea | 10 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Equipment failure | 1 | 0 |
Baseline characteristics
| Characteristic | Surgery Patients | Obstructive Sleep Apnea | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 20 Participants |
| Age, Continuous | 36 years STANDARD_DEVIATION 7 | 59 years STANDARD_DEVIATION 10 | 48 years STANDARD_DEVIATION 15 |
| Region of Enrollment United States | 10 participants | 11 participants | 21 participants |
| Sex: Female, Male Female | 10 Participants | 5 Participants | 15 Participants |
| Sex: Female, Male Male | 0 Participants | 6 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 11 | 0 / 10 |
| serious Total, serious adverse events | 0 / 11 | 0 / 10 |
Outcome results
Primary
Number of Participants Requiring Airway Support
Drugs during surgery may cause the throat to relax and block breathing. To treat this, the caregiver administers airway support. Airway support is moving the jaw forward, inserting a plastic tube (nasal-oral airway) or applying a mask with positive pressure.
Time frame: 3 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Obstructive Sleep Apnea | Number of Participants Requiring Airway Support | 8 Participants |
| Surgery Patients | Number of Participants Requiring Airway Support | 4 Participants |
Primary
Number of Participants With Saturation Pattern Detection (SPD) Indicative of Repetitive Reductions in Air Flow
Saturation Pattern Detection (SPD) is the pattern of oxygen saturation values plotted against time that occurs when patients have cyclical reduced air movement during breathing. Their blood oxygen level decreases and increases as they slow and increase their breathing.
Time frame: 3 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Obstructive Sleep Apnea | Number of Participants With Saturation Pattern Detection (SPD) Indicative of Repetitive Reductions in Air Flow | 4 Participants |
| Surgery Patients | Number of Participants With Saturation Pattern Detection (SPD) Indicative of Repetitive Reductions in Air Flow | 0 Participants |