Respiratory ComplicationsNCT07227389
Timing of Opioid Administration and Postoperative Respiratory Depression.
An observational study of Respiratory Complications and Opioid Induced Respiratory Depression, run by Wayne State University at 1 site in United States.
Trial summary
The goal of this study is to determine if a relationship can be detected between the administration of an opioid and quantitative respiratory depression in spontaneously breathing non-intubated patients who have undergone general anesthesia and have received perioperative opioids. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Complications, Opioid Induced Respiratory Depression, Postoperative Respiratory Complications
- What is being tested?
- Respiratory volume monitoring
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2026to 1 Feb 2029
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Surgical patients receiving general anesthesia with an expected anesthetic time of at least 2 hours
Who may be able to join
- Written informed consent
- Adults ≥18 years of age and ≤85 years of age
- Patients planned for general anesthesia with an expected anesthetic time of at least 2 hours
- Patients expected to receive postoperative opioid analgesia
Who cannot join
- Non-operative procedure (imaging)
- Patients not admitted to the PACU postoperatively
- Use of patient-controlled analgesia systems
- Female patients who are pregnant or breastfeeding
- Patients with asymmetric lung disease
- American Society of Anesthesiologists (ASA) classification V
- Emergency surgery (ASA E Modifier)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Detroit Medical Center
Detroit, Michigan, 48201
George McKelvey M Clinical Co-ordinator, PhD, 3135986036, George.McKelvey@northstaranesthesia.com
About this study
Official title: The Relationship Between Timing of Opioid Administration and Postoperative Respiratory Depression.
The goal of this study is to determine if a relationship can be detected between the administration of an opioid and quantitative respiratory depression in spontaneously breathing non-intubated patients who have undergone general anesthesia and have received perioperative opioids.
The primary aim is to determine the temporal effect of opioid administration on respiratory depression as assessed by minute ventilation with a reduction of at least 20% in the percent of predicted minute ventilation.
Read more
A secondary aim is to determine a dose response of opioid administration and its effect on minute ventilation.
The investigators aim to determine the influence of opioid administration on minute ventilation on spontaneously breathing patients during post-anesthesia care unit (PACU) stay.
Read the detailed description
Opioids have been used as a mainstay of perioperative analgesia since the late 18th century. The use of opioids, however, is not without risk as both short-term and long-term complications have been reported leading to in-hospital morbidity as well as increased 30-day readmission. Multiple postoperative complications are attributed to opioid administration including respiratory, cardiovascular, neurological, and gastrointestinal. As such, the routine use of opioids postoperatively is constantly being re-evaluated in search of better alternatives. For the time being, opioid prescription is largely provider dependent and hence the complications are varied. Opioids act on central and peripheral receptors leading to analgesia, but also cause worsening sleep apnea, decreased ventilatory response to hypoxia and hypercarbia, and may lead to hyperalgesia and sedation, thus feeding a vicious cycle. Certain patient populations have increased analgesic demand postoperatively and are thus at increased risk of postoperative opioid-induced respiratory depression (OIRD). This is especially true in patients with morbid obesity, chronic opioid use, obstructive sleep apnea (OSA), or sleep-disordered breathing (SDB). Higher risk patients also include those with concomitant pulmonary disease. The morbidity and mortality are even higher in the unmonitored setting. Current efforts at monitoring postoperative patients are mostly intermittent peripheral oximetry checks by the inpatient ward staff unless the patient is present in a step-down or intensive care unit. There are no clear guidelines on continuous postoperative oxygenation monitoring mostly due to the lack of published data. Intermittent checks are typically done every four or eight hours and are generally suboptimal at detecting episodes of hypoxemia. Other indirect methods of measuring hypoxemia include incidence of naloxone administration and/or code blue (cardio-respiratory arrest) emergencies. While continuous peripheral pulse oximetry in the postoperative period is currently the best available means to detect hypoxemia, it is not without flaws. Several factors can lead to falsely decreased measured oxygen saturation including motion artifacts, cold fingers, and sleep position. Oximetry would also detect hypoxemia after the oxygen reserves have been depleted, which is usually later in the process. Most preventable deaths attributable to OIRD seem to occur shortly after release from the post-anesthesia care unit (PACU) and are more likely during the night shift or during other times of decreased nursing availability. Noninvasive continuous respiratory monitoring is possible using a novel respiratory volume monitor (RVM) that utilizes bio-impedance to detect tidal volumes, respiratory rate, and minute ventilation in non-intubated patients (ExSpiron). The realtime minute ventilation (MV) as obtained from the RVM is contrasted with the calculated predicted MV according to the patients size and gender to end up with a percent of the predicted MV (%MVPRED) that relates to the degree of respiratory depression. The use and quantification of this ratio can aid in analyzing the respiratory effect that an opioid dose can have on the patient. Where a MVPRED of 80% can relate to mild respiratory depression. Here the investigators aim to capture the influence of opioid dosage on minute ventilation, with a primary outcome of a %MVPRED reduction of at least 20%. Respiratory Metrics: Respiratory metrics, including MV, %MVPRED, TV, and RR will be recorded by the Respiratory Volume Monitor (ExSpiron, Senzime, Uppsala, Sweden). Metrics will be recorded every 5 seconds and calculated as an average of the previous 30-second window. De-identified respiratory metric data will be downloaded directly from each patient every day and at the completion of the study using the built-in user interface. Clinicians will be asked to record the precise time of any respiratory interventions.
Rationale for conducting the research: The researchers propose to evaluate the effect of opioids on respiratory depression as monitored by a non-invasive respiratory volume monitor on postoperative non-intubated patients. Primarily, the aim is to determine the correlation between opioid administration and decreased respiratory function. More specifically, the immediate effect that opioid administration has on minute ventilation. In order to test this relationship, the researchers put forward a blinded observation study on adult patients in the PACU who require pain management with opioids.
Rationale for the selected participant population: Patients in the PACU often require pain management with opioids. Monitoring these patients with a non-invasive respiratory monitor for opioid induced respiratory depression (OIRD) may potentially detect adverse events earlier than conventional standard of care monitors.
- Conditions
- Respiratory Complications, Opioid Induced Respiratory Depression, Postoperative Respiratory Complications
- Being tested
- Respiratory volume monitoring
- Keywords
- opioids, bio-impedance, hypoxia, hypercapnia, minute ventilation
- Medical subject headings
- Hypoxia, Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory volume monitoringDiagnostic test
Noninvasive continuous respiratory monitoring utilizing bio-impedance to detect tidal volumes, respiratory rate, and minute ventilation.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients receiving general anesthesia with an expected anesthetic time of at least 2 hours Receives: Diagnostic Test: Respiratory volume monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory interventions 1
Initiation or cessation of mechanical ventilation
Measured: Within 4 hours of patient admittance to Post Anesthetic Care Unit (PACU)
Respiratory interventions 2
Initiation or cessation of Bilevel Positive Airway Pressure
Measured: Within 4 hours of patient admittance to Post Anesthetic Care Unit
Respiratory interventions 3
Initiation/cessation of high flow nasal cannula
Measured: Within 4 hours of patient admittance to Post Anesthetic Care Unit
Respiratory interventions 4
Initiation/cessation of low flow nasal cannula
Measured: Within 4 hours of patient admittance to Post Anesthetic Care Unit
Secondary outcomes (7)
Oxygen saturation of peripheral blood (SpO2)
Oxygen saturation of peripheral blood during PACU stay
Measured: Duration of PACU stay (up to 4 hours)
Arterial Blood gas levels
Arterial Blood gas levels during surgery
Measured: Duration of surgery (up to 2hrs)
Venous Blood gas levels
Venousl Blood gas levels during surgery
Measured: Duration of surgery (up to 2hrs)
Hypercapnia
Hypercapnic episode as measured by EtCO2
Measured: Duration of patient stay in PACU (up to 4 hours)
Hypoxia
Hypoxic episodes episode as measured by SpO2
Measured: Duration of patient stay in PACU (up to 4 hours)
Patient transfer occurrence
Patient transfer to higher/lower acuity level such as ICU, hospital floor, step-down unit
Measured: During patient stay (up to 30 days)
Initiation of patient prone position placement
Occurance time of patient placement into the prone position
Measured: During patient PACU stay (up to 4 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2025
- Study start1 Feb 2026
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory ComplicationsStudies of the same condition, open and under way.
- 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
- 52 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wael Saasouh, MD, Wayne State University
- Investigators
- Wael Saasouh, MD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07227389
- Sponsor's protocol ID
- IRB-23-08-6045
- Status last verified
- Jul 2026
- First submitted
- 7 Nov 2025
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Timing of Opioid Administration and Postoperative Respiratory Depression.
- ClinicalTrials.gov ID
- NCT07227389
- Acronym / sponsor ID
- IRB-23-08-6045
- Conditions
- Respiratory Complications, Opioid Induced Respiratory Depression, Postoperative Respiratory Complications
- Keywords
- opioids, bio-impedance, hypoxia, hypercapnia, minute ventilation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 12 Nov 2025 (actual)
- 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.
The goal of this study is to determine if a relationship can be detected between the administration of an opioid and quantitative respiratory depression in spontaneously breathing non-intubated patients who have undergone general anesthesia and have received perioperative opioids.
The primary aim is to determine the temporal effect of opioid administration on respiratory depression as assessed by minute ventilation with a reduction of at least 20% in the percent of predicted minute ventilation.
A secondary aim is to determine a dose response of opioid administration and its effect on minute ventilation.
The investigators aim to determine the influence of opioid administration on minute ventilation on spontaneously breathing patients during post-anesthesia care unit (PACU) stay.
Detailed description
Opioids have been used as a mainstay of perioperative analgesia since the late 18th century. The use of opioids, however, is not without risk as both short-term and long-term complications have been reported leading to in-hospital morbidity as well as increased 30-day readmission. Multiple postoperative complications are attributed to opioid administration including respiratory, cardiovascular, neurological, and gastrointestinal. As such, the routine use of opioids postoperatively is constantly being re-evaluated in search of better alternatives. For the time being, opioid prescription is largely provider dependent and hence the complications are varied. Opioids act on central and peripheral receptors leading to analgesia, but also cause worsening sleep apnea, decreased ventilatory response to hypoxia and hypercarbia, and may lead to hyperalgesia and sedation, thus feeding a vicious cycle. Certain patient populations have increased analgesic demand postoperatively and are thus at increased risk of postoperative opioid-induced respiratory depression (OIRD). This is especially true in patients with morbid obesity, chronic opioid use, obstructive sleep apnea (OSA), or sleep-disordered breathing (SDB). Higher risk patients also include those with concomitant pulmonary disease. The morbidity and mortality are even higher in the unmonitored setting. Current efforts at monitoring postoperative patients are mostly intermittent peripheral oximetry checks by the inpatient ward staff unless the patient is present in a step-down or intensive care unit. There are no clear guidelines on continuous postoperative oxygenation monitoring mostly due to the lack of published data. Intermittent checks are typically done every four or eight hours and are generally suboptimal at detecting episodes of hypoxemia. Other indirect methods of measuring hypoxemia include incidence of naloxone administration and/or code blue (cardio-respiratory arrest) emergencies. While continuous peripheral pulse oximetry in the postoperative period is currently the best available means to detect hypoxemia, it is not without flaws. Several factors can lead to falsely decreased measured oxygen saturation including motion artifacts, cold fingers, and sleep position. Oximetry would also detect hypoxemia after the oxygen reserves have been depleted, which is usually later in the process. Most preventable deaths attributable to OIRD seem to occur shortly after release from the post-anesthesia care unit (PACU) and are more likely during the night shift or during other times of decreased nursing availability. Noninvasive continuous respiratory monitoring is possible using a novel respiratory volume monitor (RVM) that utilizes bio-impedance to detect tidal volumes, respiratory rate, and minute ventilation in non-intubated patients (ExSpiron). The realtime minute ventilation (MV) as obtained from the RVM is contrasted with the calculated predicted MV according to the patients size and gender to end up with a percent of the predicted MV (%MVPRED) that relates to the degree of respiratory depression. The use and quantification of this ratio can aid in analyzing the respiratory effect that an opioid dose can have on the patient. Where a MVPRED of 80% can relate to mild respiratory depression. Here the investigators aim to capture the influence of opioid dosage on minute ventilation, with a primary outcome of a %MVPRED reduction of at least 20%. Respiratory Metrics: Respiratory metrics, including MV, %MVPRED, TV, and RR will be recorded by the Respiratory Volume Monitor (ExSpiron, Senzime, Uppsala, Sweden). Metrics will be recorded every 5 seconds and calculated as an average of the previous 30-second window. De-identified respiratory metric data will be downloaded directly from each patient every day and at the completion of the study using the built-in user interface. Clinicians will be asked to record the precise time of any respiratory interventions.
Rationale for conducting the research: The researchers propose to evaluate the effect of opioids on respiratory depression as monitored by a non-invasive respiratory volume monitor on postoperative non-intubated patients. Primarily, the aim is to determine the correlation between opioid administration and decreased respiratory function. More specifically, the immediate effect that opioid administration has on minute ventilation. In order to test this relationship, the researchers put forward a blinded observation study on adult patients in the PACU who require pain management with opioids.
Rationale for the selected participant population: Patients in the PACU often require pain management with opioids. Monitoring these patients with a non-invasive respiratory monitor for opioid induced respiratory depression (OIRD) may potentially detect adverse events earlier than conventional standard of care monitors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Diagnostic Test: Respiratory volume monitoringPatients receiving general anesthesia with an expected anesthetic time of at least 2 hours |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Surgical patients receiving general anesthesia with an expected anesthetic time of at least 2 hours
Key inclusion criteria (4 listed)
- Written informed consent
- Adults ≥18 years of age and ≤85 years of age
- Patients planned for general anesthesia with an expected anesthetic time of at least 2 hours
- Patients expected to receive postoperative opioid analgesia
Key exclusion criteria (7 listed)
- Non-operative procedure (imaging)
- Patients not admitted to the PACU postoperatively
- Use of patient-controlled analgesia systems
- Female patients who are pregnant or breastfeeding
- Patients with asymmetric lung disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory volume monitoringNoninvasive continuous respiratory monitoring utilizing bio-impedance to detect tidal volumes, respiratory rate, and minute ventilation. | Diagnostic test | Study group |
Primary outcome
Respiratory interventions 1
Time frame: Within 4 hours of patient admittance to Post Anesthetic Care Unit (PACU)
Initiation or cessation of mechanical ventilation
Respiratory interventions 2
Time frame: Within 4 hours of patient admittance to Post Anesthetic Care Unit
Initiation or cessation of Bilevel Positive Airway Pressure
Respiratory interventions 3
Time frame: Within 4 hours of patient admittance to Post Anesthetic Care Unit
Initiation/cessation of high flow nasal cannula
Respiratory interventions 4
Time frame: Within 4 hours of patient admittance to Post Anesthetic Care Unit
Initiation/cessation of low flow nasal cannula
7 secondary outcomes
Oxygen saturation of peripheral blood (SpO2)
Time frame: Duration of PACU stay (up to 4 hours)
Arterial Blood gas levels
Time frame: Duration of surgery (up to 2hrs)
Venous Blood gas levels
Time frame: Duration of surgery (up to 2hrs)
Hypercapnia
Time frame: Duration of patient stay in PACU (up to 4 hours)
Hypoxia
Time frame: Duration of patient stay in PACU (up to 4 hours)
Patient transfer occurrence
Time frame: During patient stay (up to 30 days)
Initiation of patient prone position placement
Time frame: During patient PACU stay (up to 4 hours)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- 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.
Wael Saasouh, MD principal investigator
Wayne State University
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 Respiratory Complications and Opioid Induced Respiratory Depression, run by Wayne State University 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 16 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact George M McKelvey, PhD (3135986036, George.McKelvey@northstaranesthesia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory interventions 1 (time frame: Within 4 hours of patient admittance to Post Anesthetic Care Unit (PACU)). The study lists 4 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 16 Jul 2026.