Obstructive Sleep ApneaNCT02930538
Can Postoperative Outcomes be Predicted From Asking OSA Screening Questions Pre-operatively?
An observational study of Obstructive Sleep Apnea, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
The proposed research will determine whether a 6-item screening questionnaire previously shown to correlate with moderate or severe OSA is useful for predicting postoperative outcomes in children undergoing surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Survey
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2016to 2 Nov 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children having surgery at Nationwide Children's Hosp (NCH).
Who may be able to join
- The study will include all who are presenting for surgery to the main operating room, ambulatory surgical center or procedure center at Nationwide Children's Hospital.
Who cannot join
- Emergency surgery and any caregiver or patient refusal.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
The proposed research will determine whether a 6-item screening questionnaire previously shown to correlate with moderate or severe OSA is useful for predicting postoperative outcomes in children undergoing surgery under general anesthesia.
Read the detailed description
The survey will be administered preoperatively in the ENT clinic or the preoperative surgical unit. The following data will also be recorded: patient demographics (age, gender, BMI), surgical procedure, length of procedure and anesthetic, and smoking exposure. Based on differences in postoperative outcomes (e.g., supplemental oxygen requirement in the PACU) observed in the derivation cohort for the 6-item questionnaire, the study will enroll 1,000 patients to attain sufficient power for evaluating the 6-item questionnaire in the overall cohort and in demographically or clinically defined subgroups.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Survey
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Completing a survey on RedCap
| Study group | Role | What they receive |
|---|---|---|
| Children undergoing surgery | Children ages 3-18 undergoing a surgical procedure at Nationwide Children's Hosp. Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liters of Oxygen
The patient's oxygen requirement while in the PACU.
Measured: 1 hr post-op
Secondary outcomes (2)
Narcotic usage in mg
The patient's opiod requirement while in the PACU.
Measured: 1 hr post-op
PACU length of stay
Measured: 1-2 hr post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2016 (estimated)
- Study start22 Nov 2016
- Primary completion2 Nov 2021
- Study completion2 Nov 2021
Why it stopped: PI left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vidya Raman, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02930538
- Sponsor's protocol ID
- IRB16-00491
- Status last verified
- Feb 2022
- First submitted
- 15 Sep 2016
- Last updated
- 14 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Postoperative Outcomes be Predicted From Asking OSA Screening Questions Pre-operatively?
- ClinicalTrials.gov ID
- NCT02930538
- Acronym / sponsor ID
- IRB16-00491
- Conditions
- Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI left the institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- 22 Nov 2016 (actual)
- Primary completion
- 2 Nov 2021 (actual)
- Study completion
- 2 Nov 2021 (actual)
- First posted
- 12 Oct 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.
The proposed research will determine whether a 6-item screening questionnaire previously shown to correlate with moderate or severe OSA is useful for predicting postoperative outcomes in children undergoing surgery under general anesthesia.
Detailed description
The survey will be administered preoperatively in the ENT clinic or the preoperative surgical unit. The following data will also be recorded: patient demographics (age, gender, BMI), surgical procedure, length of procedure and anesthetic, and smoking exposure. Based on differences in postoperative outcomes (e.g., supplemental oxygen requirement in the PACU) observed in the derivation cohort for the 6-item questionnaire, the study will enroll 1,000 patients to attain sufficient power for evaluating the 6-item questionnaire in the overall cohort and in demographically or clinically defined subgroups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children undergoing surgery | – | Other: SurveyChildren ages 3-18 undergoing a surgical procedure at Nationwide Children's Hosp. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children having surgery at Nationwide Children's Hosp (NCH).
Key inclusion criteria (1 listed)
- The study will include all who are presenting for surgery to the main operating room, ambulatory surgical center or procedure center at Nationwide Children's Hospital.
Key exclusion criteria (1 listed)
- Emergency surgery and any caregiver or patient refusal.
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 |
|---|---|---|
| SurveyCompleting a survey on RedCap | Other | Children undergoing surgery |
Primary outcome
Liters of Oxygen
Time frame: 1 hr post-op
The patient's oxygen requirement while in the PACU.
2 secondary outcomes
Narcotic usage in mg
Time frame: 1 hr post-op
PACU length of stay
Time frame: 1-2 hr post-op
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Obstructive Sleep Apnea, run by Nationwide Children's Hospital 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 14 Feb 2022. 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 was withdrawn before enrolling participants, so there are no results.
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?
Liters of Oxygen (time frame: 1 hr post-op). 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 14 Feb 2022.