Respiratory ComplicationsNCT02729077
Risk Factors for Post-Operative Respiratory Complications in Patients at Risk for OSA
An observational study of Respiratory Complications, run by Ohio State University at 1 site in United States.
Trial summary
This study investigates the incidence of postoperative respiratory complications (PRCs) including: oxygen desaturation events, tracheal re-intubations within 48 hours of surgery, and failure to wean from ventilator within 48 hours of surgery - in patients with and without risk factors for OSA undergoing elective… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Complications
- What is being tested?
- Pulse Oximetry
- Type of treatment
- Medical device
- How many people
- 324 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 4 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients at Ohio State University Wexner Medical Center, aged between 18-75 years, with an American Society of Anesthesiologists (ASA) physical status of I (normal healthy patient), II (patients with mild systemic disease; no functional limitation) or III (patient with severe systemic disease; definite functional impairment - with relatively stable disease, but requiring therapy) who are scheduled to undergo elective surgeries under sevoflurane general anesthesia as a standard of care.
Who may be able to join
- Male or female , 18 to 75 years of age
- ASA I, II or III
- Capable and willing to consent
- Participants literate in English language
Who cannot join
- ASA IV or V
- Patients with severe visual or auditory disorder
- Illiteracy
- Chronic Obstructive Pulmonary Disease
- Restrictive Lung Diseases
- Benzodiazepines use
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- Patients who were undergoing surgical procedures involving the upper airway, including tonsillectomy, septoplasty, uvuloplasty, uvulopalatoplasty, uvulopharyngoplasty, or uvulopalatopharyngoplasty, as these procedures were most likely to have been indicated to cure the primary disease process (OSA)
- Cardiac surgeries
- Neurosurgeries (Brain)
- Any condition, which in the opinion of the investigator would make subject ineligible for participation in the study such as history of unstable cardiovascular, pulmonary, renal, hepatic, neurologic (seizures), hematologic or endocrine abnormality (hyperthyroidism, unstable Diabetes type I/II)
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
Official title: PERIOPERATIVE RISK FACTORS FOR POSTOPERATIVE RESPIRATORY COMPLICATIONS IN PATIENTS AT RISK FOR OBSTRUCTIVE SLEEP APNEA
This study investigates the incidence of postoperative respiratory complications (PRCs) including: oxygen desaturation events, tracheal re-intubations within 48 hours of surgery, and failure to wean from ventilator within 48 hours of surgery - in patients with and without risk factors for OSA undergoing elective, non-cardiac surgery (NCS).
Read the detailed description
324 subjects will be enrolled into one of two groups: increased or not increased risk for OSA, n=162 patients per group. Preoperative assessments of OSA status, Mallampati score (an assessment for mouth and throat morphology), STOP-BANG test (assessment for risk of OSA), and medical history will be used to determine patient group assignment. All subjects will receive standard general anesthesia and monitoring as a part of standard of care whether or not she/he will participate in the study, including ECG, arterial pressure, SpO2, BIS, Blood pressure (BP), heart rate (HR), and respiratory rate (RR), all of which will be continuously recorded and data will be saved for every three minutes during induction using standard monitors. Standard monitoring assessments in PACU will be used, and patients with increased perioperative risk for OSA will be closely monitored for hypoxemia and other complications. The Nellcor Pulse Oximetry Sensor will be applied in PACU and continuously monitor the patient's oxygen saturation and respiratory rate for the first 48 hours postoperatively. At the end of the 48 hours, the device will be removed, and the de-identified data will be transferred to a computer with analysis software and examined for patterns in respiratory distress in both patient groups. Data collected from the Nellcor Bedside Respiratory Patient Monitoring System on pulse and oxygen saturation, as well as data on clinically significant events, such as PRCs, acute respiratory failure, tracheal reintubation, hypoxemia, CHF, MI, A-fib, and delirium will be analyzed to understand the effects of OSA on postoperative recovery
- Conditions
- Respiratory Complications
- Being tested
- Pulse Oximetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse OximetryDevice
Use of pulse oximetry device for 48 hours after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Increased risk for OSA | Vital signs including oxygen saturation, respiratory rate, ECG, arterial pressure, BIS, blood pressure, heart rate will be monitored and hypoxemia will be measured during anesthetic care, and oxygen saturation and respiratory rate will be measured for 48 hours after surgery with pulse oximetry. Patients in this arm will be especially evaluated for hypoxemia and other complications. Receives: Device: Pulse Oximetry | |
| Not increased risk for OSA | Vital signs including oxygen saturation, respiratory rate, ECG, arterial pressure, BIS, blood pressure, heart rate will be monitored and hypoxemia will be measured during anesthetic care, and oxygen saturation and respiratory rate will be measured for 48 hours after surgery with pulse oximetry. Receives: Device: Pulse Oximetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of postoperative respiratory complications (PRCs) based on cumulative minutes per 24 hours of oxygen desaturation events ≤ 90%
Identify respiratory complications such as hypoxemia, respiratory failure requiring assisted ventilation, and reintubation, every 24 hours
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startJul 2016
- Primary completion4 Feb 2021
- Study completion4 Feb 2021
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.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic - MITG
- Responsible party
- Principal investigator, Jyoti Pandya, Ohio State University
- Investigators
- Nicoleta Stoicea, MD, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02729077
- Sponsor's protocol ID
- 2015H0052
- Status last verified
- Feb 2021
- First submitted
- 31 Mar 2016
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PERIOPERATIVE RISK FACTORS FOR POSTOPERATIVE RESPIRATORY COMPLICATIONS IN PATIENTS AT RISK FOR OBSTRUCTIVE SLEEP APNEA
- ClinicalTrials.gov ID
- NCT02729077
- Acronym / sponsor ID
- 2015H0052
- Conditions
- Respiratory Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Medtronic - MITG
- Study start
- Jul 2016
- Primary completion
- 4 Feb 2021 (actual)
- Study completion
- 4 Feb 2021 (actual)
- First posted
- 6 Apr 2016 (estimated)
- 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.
This study investigates the incidence of postoperative respiratory complications (PRCs) including: oxygen desaturation events, tracheal re-intubations within 48 hours of surgery, and failure to wean from ventilator within 48 hours of surgery - in patients with and without risk factors for OSA undergoing elective, non-cardiac surgery (NCS).
Detailed description
324 subjects will be enrolled into one of two groups: increased or not increased risk for OSA, n=162 patients per group. Preoperative assessments of OSA status, Mallampati score (an assessment for mouth and throat morphology), STOP-BANG test (assessment for risk of OSA), and medical history will be used to determine patient group assignment. All subjects will receive standard general anesthesia and monitoring as a part of standard of care whether or not she/he will participate in the study, including ECG, arterial pressure, SpO2, BIS, Blood pressure (BP), heart rate (HR), and respiratory rate (RR), all of which will be continuously recorded and data will be saved for every three minutes during induction using standard monitors. Standard monitoring assessments in PACU will be used, and patients with increased perioperative risk for OSA will be closely monitored for hypoxemia and other complications. The Nellcor Pulse Oximetry Sensor will be applied in PACU and continuously monitor the patient's oxygen saturation and respiratory rate for the first 48 hours postoperatively. At the end of the 48 hours, the device will be removed, and the de-identified data will be transferred to a computer with analysis software and examined for patterns in respiratory distress in both patient groups. Data collected from the Nellcor Bedside Respiratory Patient Monitoring System on pulse and oxygen saturation, as well as data on clinically significant events, such as PRCs, acute respiratory failure, tracheal reintubation, hypoxemia, CHF, MI, A-fib, and delirium will be analyzed to understand the effects of OSA on postoperative recovery
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Increased risk for OSA | – | Device: Pulse OximetryVital signs including oxygen saturation, respiratory rate, ECG, arterial pressure, BIS, blood pressure, heart rate will be monitored and hypoxemia will be measured during anesthetic care, and oxygen saturation and respiratory rate will be measured for 48 hours after surgery with pulse oximetry. Patients in this arm will be especially evaluated for hypoxemia and other complications. |
| Not increased risk for OSA | – | Device: Pulse OximetryVital signs including oxygen saturation, respiratory rate, ECG, arterial pressure, BIS, blood pressure, heart rate will be monitored and hypoxemia will be measured during anesthetic care, and oxygen saturation and respiratory rate will be measured for 48 hours after surgery with pulse oximetry. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients at Ohio State University Wexner Medical Center, aged between 18-75 years, with an American Society of Anesthesiologists (ASA) physical status of I (normal healthy patient), II (patients with mild systemic disease; no functional limitation) or III (patient with severe systemic disease; definite functional impairment - with relatively stable disease, but requiring therapy) who are scheduled to undergo elective surgeries under sevoflurane general anesthesia as a standard of care.
Key inclusion criteria (4 listed)
- Male or female , 18 to 75 years of age
- ASA I, II or III
- Capable and willing to consent
- Participants literate in English language
Key exclusion criteria (10 listed)
- ASA IV or V
- Patients with severe visual or auditory disorder
- Illiteracy
- Chronic Obstructive Pulmonary Disease
- Restrictive Lung Diseases
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 |
|---|---|---|
| Pulse OximetryUse of pulse oximetry device for 48 hours after surgery. | Device | Increased risk for OSA, Not increased risk for OSA |
Primary outcome
incidence of postoperative respiratory complications (PRCs) based on cumulative minutes per 24 hours of oxygen desaturation events ≤ 90%
Time frame: 24 hours
Identify respiratory complications such as hypoxemia, respiratory failure requiring assisted ventilation, and reintubation, every 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- 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. This study is not recruiting at the moment.
Nicoleta Stoicea, MD, PhD principal investigator
Ohio 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, run by Ohio 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 10 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: finished, as of the sponsor's last update on 24 Feb 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of postoperative respiratory complications (PRCs) based on cumulative minutes per 24 hours of oxygen desaturation events ≤ 90% (time frame: 24 hours). 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 24 Feb 2021.