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| Name | Class |
|---|---|
| Bispebjerg Hospital | OTHER |
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Aim: To describe the duration of desaturation and bradypnea in postoperative opioid-naïve and chronic opioid patients. Patients: 691 patients included from two previous WARD (Wireless Assessment of Respiratory and circulatory Distress) projects. Outcome: Respiratory deviations four hours after opioid administration
Aim: To describe the duration of desaturation and bradypnea in postoperative opioid-naïve and chronic opioid patients within the first four hours following opioid administration in addition to the chronic dose, using a continuously wireless monitoring system.
Patients: 691 patients included from two previous WARD (Wireless Assessment of Respiratory and circulatory Distress) projects. Continuous wireless monitoring data of peripheral tissue oxygenation (SpO2) and respiratory rate (RR) was conducted in postoperative patients. Data were stratified into opioid-naïve and chronic opioid patients, based on their preoperative opioid history. Patients who did not receive opioids postoperatively were served as the control group. Data was evaluated one hour before and four hours after opioid administration. The primary outcome was the cumulative duration of SpO2 <88%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opioid-naive patients | Opioid-naive patients are defined as the absence of any documented opioid use in the available preoperatively medical records, and are receiving opioids postoperatively |
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| Chronic opioid patients | Chronic opioid patients were defined as current or previous use of the following medications, re-gardless of the duration of use: morphine, tramadol, tapentadol, fentanyl, oxycodone, ketobe-midone, methadone, or buprenorphine. This was verified through patients' preoperative medical records. All chronic opioid users received postoperative opioids. |
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| Control group | Patients who did not receive pre- or postoperative opioids were served as the overall control group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous vital sign monitoring | Device | Wireless monitoring system that provided continuous, non-invasive collection of their vital signs, including peripheral oxygen saturation (SpO2) and respiratory rate (RR), for up to 92 hours following surgery or until discharge. The respiratory rate was monitored via FDA-approved Isansys Lifetouch electrocardiogram (ECG) patch, which was placed on the left side of the chest. SpO2 levels were continuously recorded using the Nonin WristOx 3150, a wrist-mounted finger oximeter. |
| Measure | Description | Time Frame |
|---|---|---|
| SpO2 <88% in the four hours following opioid administration | four hours following opioid administration |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory deviations four hours after opioid administration | SpO2 <92%, <88 %, <85%, <80% and respiratory rate ≤11 min-1, ≤8 min-1, ≤5 min-1 | four hours following opioid administration |
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Inclusion Criteria:
Exclusion Criteria:
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Patients from studies WARD Surgery Observational [gov: NCT03491137] and the control group from a WARD Surgery Randomized Controlled Trial (RCT) [gov: NCT04640415 - submitted] were assessed for inclusion eligibility.
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| Name | Affiliation | Role |
|---|---|---|
| Eske Kvanner Aasvang, Professor | Rigshospitalet, Denmark | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | 2100 | Denmark | |||
| Bispebjerg Hospital |
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| ID | Term |
|---|---|
| D007040 | Hypoventilation |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
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| Copenhagen |
| 2400 |
| Denmark |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |