Respiratory Depression
Conditions
Brief summary
PRODIGY is a prospective, multi-center, post-market, international cohort study. The primary objective of this study is to derive a score to identify subjects at risk to have respiratory depression (RD) episodes in patients undergoing opioid therapy in the hospital ward and monitored by capnography. The score will be derived by using subjects within the derivation cohort and internally validated using subjects within the validation cohort. The primary endpoint used to derive the score will be the occurrence of RD episodes derived by Capnostream 20p device memory data combined with clinical data and validated by an independent Clinical Endpoint Committee (CEC) during the study course.
Interventions
DEVICECapnostream Monitor
Capnography and pulse oximetry monitoring data will be collected for up to 48 hours while patients are on the hospital ward. In addition, a 1-month follow up will be completed.
Sponsors
Medtronic - MITG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients receiving parenteral opioid therapy (for post-surgical or non-surgical) pain on the hospital ward. 2. Adult age (≥18 year old in US and Europe; ≥20 years old in Japan; ≥21 years old in Singapore). 3. Patient is able and willing to give informed consent.
Exclusion criteria
1. Expected length of stay ≤ 24 hours. 2. Patient is receiving intrathecal opioids. 3. Post-surgical patients with American Society of Anesthesiologists physical status (ASA PS) V or higher. 4. Patients with the status of Do Not Resuscitate (DNR), hospice, or receiving end of life therapy. 5. Ventilated or intubated patients. 6. Patient is unwilling or unable to comply fully with study procedures (including non-toleration of the capnography cannula) due to any disease condition which can raise doubt about compliance and influencing the study outcome. 7. Patient is a member of a vulnerable population, including legal incapacity or evidence that a subject cannot understand the purpose and risks of the study, regardless of authorized representative support. 8. Patient is participating in another potentially confounding drug or device clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine Number of Subjects With RD While on Opioid Therapy | 48 hours | Continuous respiratory monitoring using a Capnostream monitor will be included for collecting data for end tidal carbon dioxide (etCO2) and Oxygen saturation (SpO2). Positive RD determination was provided by an independent Clinical Event Committee, by assessing the following parameters: * etCO2 ≤ 15 or ≥ 60 mmHg for ≥ 3 minutes, or * RR ≤ 5 breaths for ≥ 3 minutes, or * SpO2 ≤ 85% for ≥ 3 minutes, or * Apnea episode lasting \> 30 seconds, or * Any respiratory Opioid-Related Adverse Event (rORADE). |
| To Derive and Validate a Risk Assessment Tool to Identify Subjects at Risk of Having RD While Undergoing Opioid Therapy on the Hospital Ward | 48 hours | A risk assessment tool will be derived and validated using the incidence of RD episodes captured by continuous capnography and pulse oximetry measurements recorded on the Capnostream device memory data in conjunction with the clinical data as reported by the investigator. |
Countries
France, Germany, Japan, Netherlands, Singapore, Spain, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Cohort Blinded capnography monitoring - all subjects enrolled | 1,495 |
| Total | 1,495 |
Baseline characteristics
| Characteristic | Single Cohort |
|---|---|
| Age, Continuous | 58.1 years STANDARD_DEVIATION 14.1 |
| Altitude Above Sea Level to Below High Alititude | 1228 Participants |
| Altitude At or Below Sea Level | 72 Participants |
| Altitude High Altitude (1500-3500 meters) | 105 Participants |
| Altitude Missing Data | 87 Participants |
| Altitude Very High Altitude (above 3500 meters) | 3 Participants |
| Apnea History Snore Loudly Missing Data | 95 Participants |
| Apnea History Snore Loudly No | 955 Participants |
| Apnea History Snore Loudly Yes | 445 Participants |
| Apnea History Stop Breathing or Choking/Gasping During Sleep Missing Data | 94 Participants |
| Apnea History Stop Breathing or Choking/Gasping During Sleep No | 1249 Participants |
| Apnea History Stop Breathing or Choking/Gasping During Sleep Yes | 152 Participants |
| Apnea History Tired, Fatigued, Sleepy During the Day Missing Data | 96 Participants |
| Apnea History Tired, Fatigued, Sleepy During the Day No | 1132 Participants |
| Apnea History Tired, Fatigued, Sleepy During the Day Yes | 267 Participants |
| Apnea History Treated for High Blood Pressure Missing Data | 5 Participants |
| Apnea History Treated for High Blood Pressure No | 812 Participants |
| Apnea History Treated for High Blood Pressure Yes | 678 Participants |
| ASA Score Class I | 122 Participants |
| ASA Score Class II | 703 Participants |
| ASA Score Class III | 610 Participants |
| ASA Score Class IV | 33 Participants |
| ASA Score Missing Data | 27 Participants |
| Body Mass Index | 29.7 kg/m^2 STANDARD_DEVIATION 8.3 |
| Height | 167.1 cm STANDARD_DEVIATION 10.9 |
| Race/Ethnicity, Customized Race/Ethnic Origin American Indian or Alaska Native | 5 Participants |
| Race/Ethnicity, Customized Race/Ethnic Origin Asian | 325 Participants |
| Race/Ethnicity, Customized Race/Ethnic Origin Black or African American | 174 Participants |
| Race/Ethnicity, Customized Race/Ethnic Origin Hispanic or Latino | 10 Participants |
| Race/Ethnicity, Customized Race/Ethnic Origin Missing Data | 105 Participants |
| Race/Ethnicity, Customized Race/Ethnic Origin Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnic Origin Other | 36 Participants |
| Race/Ethnicity, Customized Race/Ethnic Origin White | 839 Participants |
| Region of Enrollment France | 52 participants |
| Region of Enrollment Germany | 57 participants |
| Region of Enrollment Japan | 219 participants |
| Region of Enrollment Netherlands | 92 participants |
| Region of Enrollment Singapore | 100 participants |
| Region of Enrollment Spain | 97 participants |
| Region of Enrollment United States | 878 participants |
| Sex: Female, Male Female | 859 Participants |
| Sex: Female, Male Male | 635 Participants |
| Shirt Collar Neck Size Female - shirt collar <16 in/41 cm | 561 Participants |
| Shirt Collar Neck Size Female - shirt collar >=16 in/41 cm | 259 Participants |
| Shirt Collar Neck Size Male - shirt collar <17 in/43 cm | 377 Participants |
| Shirt Collar Neck Size Male - shirt collar >= 17 in/43 cm | 221 Participants |
| Shirt Collar Neck Size Missing Data | 77 Participants |
| STOP-BANG Score | 2.8 units on a scale STANDARD_DEVIATION 1.7 |
| Weight | 83.2 kg STANDARD_DEVIATION 25.2 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 1,495 |
| other Total, other adverse events | 181 / 1,495 |
| serious Total, serious adverse events | 145 / 1,495 |
Outcome results
Primary
Determine Number of Subjects With RD While on Opioid Therapy
Continuous respiratory monitoring using a Capnostream monitor will be included for collecting data for end tidal carbon dioxide (etCO2) and Oxygen saturation (SpO2). Positive RD determination was provided by an independent Clinical Event Committee, by assessing the following parameters: * etCO2 ≤ 15 or ≥ 60 mmHg for ≥ 3 minutes, or * RR ≤ 5 breaths for ≥ 3 minutes, or * SpO2 ≤ 85% for ≥ 3 minutes, or * Apnea episode lasting \> 30 seconds, or * Any respiratory Opioid-Related Adverse Event (rORADE).
Time frame: 48 hours
Population: A modified dataset (mFAS) was used to derive and validate the risk assessment tool. Subjects with major deviations or consent withdrawals; subjects which had no continuous monitoring data were also excluded. A total of 1336 patients were included in the derivation and validation of the tool.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Full Analysis Set | Determine Number of Subjects With RD While on Opioid Therapy | RD | 655 Participants |
| Full Analysis Set | Determine Number of Subjects With RD While on Opioid Therapy | No RD | 840 Participants |
Primary
To Derive and Validate a Risk Assessment Tool to Identify Subjects at Risk of Having RD While Undergoing Opioid Therapy on the Hospital Ward
A risk assessment tool will be derived and validated using the incidence of RD episodes captured by continuous capnography and pulse oximetry measurements recorded on the Capnostream device memory data in conjunction with the clinical data as reported by the investigator.
Time frame: 48 hours
Population: A modified dataset (mFAS) was used to derive and validate the risk assessment tool. Subjects excluded from the mFAS had major deviations or consent withdrawals or had no continuous monitoring data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Full Analysis Set | To Derive and Validate a Risk Assessment Tool to Identify Subjects at Risk of Having RD While Undergoing Opioid Therapy on the Hospital Ward | Low Risk for RD | 351 Participants |
| Full Analysis Set | To Derive and Validate a Risk Assessment Tool to Identify Subjects at Risk of Having RD While Undergoing Opioid Therapy on the Hospital Ward | Intermediate Risk for RD | 457 Participants |
| Full Analysis Set | To Derive and Validate a Risk Assessment Tool to Identify Subjects at Risk of Having RD While Undergoing Opioid Therapy on the Hospital Ward | High Risk for RD | 458 Participants |
Comparison: A modified Full Analysis Dataset (1335) was used to derive and validate the risk assessment tool. Subjects were excluded if they had major deviations or consent withdrawals. Subjects that did not have any monitoring data were also excluded. Finally, 69 subjects were further excluded from the model, as they were missing parameters to calculate their risk score.95% CI: [0.73, 0.79]