Sleep Disordered BreathingNCT01851798
Evaluation of Sleep Disordered Breathing Following Ambulatory Surgery
An observational study of Sleep Disordered Breathing, run by Walter Reed National Military Medical Center at 1 site in United States.
Trial summary
Obstructive sleep apnea (OSA) is a relatively common medical condition that includes upper-airway obstruction and consequent cessation of breathing during sleep with significant associated other medical problems. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Sleep Disordered Breathing
- What is being tested?
- Home sleep test administered to all enrolled subjects
- How many people
- 203 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Dec 2015
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ambulatory orthopedic surgery patients presenting to Walter Reed National Military Medical Center
Who may be able to join
- Male and female military health care beneficiaries between the ages of 18 and 85 years presenting for elective ambulatory orthopedic surgery at WRNMMC main operating room.
- American Society of Anesthesiologist physical classification (ASA) I-II
- Scheduled for elective ambulatory orthopedic surgery
- Patients English speaking and capable of providing informed consent.
Who cannot join
- Patients who are pregnant or breast-feeding at the time of the procedure. Pregnancy will be ruled out by day of surgery urine human chorionic gonadotropin (HCG) when appropriate.
- Chronic opioid, benzodiazepine, pregabalin, or other sedating medication users
- Chronic alcohol users (defined by daily or greater use upon standard anesthesia preoperative interview)
- Patients who require home oxygen use
- Patients who have a tracheostomy
- Patients who decline to participate.
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
About this study
Official title: Postoperative Home Sleep Test Changes in Ambulatory Surgical Patients With and Without Obstructive Sleep Apnea: A Prospective Clinical Trial
Obstructive sleep apnea (OSA) is a relatively common medical condition that includes upper-airway obstruction and consequent cessation of breathing during sleep with significant associated other medical problems. The time period around surgery has been demonstrated to be an independent risk factor for various complications but the mechanism is not well understood.
This protocol proposes to study the fundamental question of what changes occur in the postoperative setting to ambulatory patients with and without OSA by administering a validated "STOP-BANG" screening questionnaire and conducting preoperative and postoperative Home Sleep Testing (HST). In doing so, critical evidence shall be gained in the understanding of postoperative sleep disorder breathing changes associated with surgery and anesthesia. With evidence, sound perioperative management recommendations and policy may be developed to assist with caring for this large and at risk surgical population.
Read the detailed description
Obstructive sleep apnea (OSA) is a highly prevalent syndrome of upper-airway obstruction and consequent cessation of respiration during sleep. Associated complications include impairment in the cardiovascular and cerebrovascular, neurological and endocrine systems. There is growing concern that the perioperative period may acutely worsen existing OSA or potentially induce sleep disordered breathing in susceptible individuals. Indeed, the presence of OSA has been shown to be an independent risk factor for perioperative complications. The mechanism for this perioperative risk, however, has yet to be fully elucidated.
This study proposes to investigate the relationship between surgical anesthesia and OSA with an observational prospective single-blinded investigation. A sample of 600 adult female and male orthopedic surgery patients scheduled for elective ambulatory orthopedic surgery at WRNMMC will be enrolled. Study subjects shall undergo an unattended Home Sleep Test (HST) the night before surgery followed by surgery and anesthesia as determined by the surgical team unchanged by study participation. Following the surgical procedure and anesthesia, the study subject will undergo a series of two additional HSTs on the first night following surgery and again on post-operative night three and complete a postoperative questionnaire including a validated screening questionnaire and information pertaining to postoperative pain and medication use.
Qualitative and quantitative analysis will be performed on the data. The prevalence in the ambulatory orthopedic population of screening positive with the STOP-BANG questionnaire, a validated Obstructive Sleep Apnea (OSA) screening tool, will be determined as well as the prevalence of OSA diagnosed by the preoperative Home Sleep Test (HST). The analysis of the HST data will be blinded as to OSA status, if known, and screening results using the validated "STOP-BANG" screening questionnaire. There are several additional research questions posed in this observational prospective single-blinded clinical study to determine if OSA, as defined by apnea-hypopnea index (AHI), is a significant factor in adverse events associated with ambulatory orthopedic surgery. First, a study sample size of 600 was selected to provide 82% power to detect a significant difference in unplanned admissions between patients with OSA (estimated at 20% of the surgical orthopedic population) and without OSA. This assumes 10% of patients without OSA experience unplanned admissions compared with 20% of patients with OSA. Other adverse perioperative events to be examined include difficult intubations, upper airway obstruction after extubation, bronchospasm, laryngospasm, arrhythmia such as atrial fibrillation, and need for mechanical ventilation
Additional questions to be examined include if surgery and anesthesia, the specific anesthetic technique, intraoperative sedative use, or postoperative sedative use is associated with any Home Sleep Test (HST) parameter (AHI, Oxygen Desaturation Index (ODI), pulse oximetry (SpO2) nadir, or percentage of time SpO2<90%). Paired t-tests will be used to perform the analyses except for the question of anesthetic technique for which analysis of variance followed by Tukey's post-hoc multiple comparisons will be employed.
Lastly is the clinically relevant question addressing whether there is a difference between patients who screen as high risk for OSA and those who screen as low risk for OSA with regard to pre and postoperative AHI, ODI, SpO2 nadir, or percentage of time SpO2<90%? High- and low-risk patients per the screening instrument will be compared using t-tests for independent samples.
Ultimately understanding the relationship between surgical anesthesia and OSA may be used to risk stratify patients, identify those at an increased risk for perioperative complications, or potentially aid in determining perioperative management plans.
- Conditions
- Sleep Disordered Breathing
- Being tested
- Home sleep test administered to all enrolled subjects
- Keywords
- OSA, Sleep disordered breathing, anesthesia, ambulatory orthopedic surgery
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home sleep test administered to all enrolled subjectsOther
| Study group | Role | What they receive |
|---|---|---|
| ambulatory orthopedic surgery patients with OSA | ambulatory orthopedic surgery patients with home sleep test preoperative AHI => 5 Receives: Other: Home sleep test administered to all enrolled subjects | |
| ambulatory orthopedic surgery patients without OSA | ambulatory orthopedic surgery patients with home sleep test preoperative AHI < 5 Receives: Other: Home sleep test administered to all enrolled subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unplanned hospital admission
Measured: First three post operative days
Secondary outcomes (1)
Prevalence of OSA in orthopedic ambulatory surgical population
Prevalence of OSA in study population will be evaluated by preoperative home sleep test. The number of enrolled subject who have a home sleep test Apnea Hypopnea Index (AHI)=>5 will be considered positive. Prevalence will be determined by the percent of subjects who test positive of all those enrolled over the study period.
Measured: Determined by home sleep test on night before surgery over study duration expected to be 2-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Staffing changes precluded sleep study interpretation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Disordered BreathingStudies 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
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Uniformed Services University of the Health Sciences
- Responsible party
- Principal investigator, Arlene Hudson, Walter Reed National Military Medical Center
- Investigators
- Arlene Hudson, MD, Principal investigator, Walter Reed National Military Medical Center and Uniformed Services University of the Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01851798
- Sponsor's protocol ID
- WRNMMC IRB#384867
- Status last verified
- Dec 2015
- First submitted
- 8 May 2013
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hudson AJ, Walter RJ, Flynn J, Szpisjak DF, Olsen C, Rodgers M, Capaldi VF 2nd, McDuffie B, Lettieri CJ. Ambulatory Surgery Has Minimal Impact on Sleep Parameters: A Prospective Observational Trial. J Clin Sleep Med. 2018 Apr 15;14(4):593-602. doi: 10.5664/jcsm.7052.
PubMed 29609705
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Home Sleep Test Changes in Ambulatory Surgical Patients With and Without Obstructive Sleep Apnea: A Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT01851798
- Acronym / sponsor ID
- WRNMMC IRB#384867
- Conditions
- Sleep Disordered Breathing
- Keywords
- OSA, Sleep disordered breathing, anesthesia, ambulatory orthopedic surgery
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Staffing changes precluded sleep study interpretation
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Walter Reed National Military Medical CenterUS federal agency
- Collaborators
- Uniformed Services University of the Health Sciences
- Study start
- Apr 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 10 May 2013 (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.
Obstructive sleep apnea (OSA) is a relatively common medical condition that includes upper-airway obstruction and consequent cessation of breathing during sleep with significant associated other medical problems. The time period around surgery has been demonstrated to be an independent risk factor for various complications but the mechanism is not well understood.
This protocol proposes to study the fundamental question of what changes occur in the postoperative setting to ambulatory patients with and without OSA by administering a validated "STOP-BANG" screening questionnaire and conducting preoperative and postoperative Home Sleep Testing (HST). In doing so, critical evidence shall be gained in the understanding of postoperative sleep disorder breathing changes associated with surgery and anesthesia. With evidence, sound perioperative management recommendations and policy may be developed to assist with caring for this large and at risk surgical population.
Detailed description
Obstructive sleep apnea (OSA) is a highly prevalent syndrome of upper-airway obstruction and consequent cessation of respiration during sleep. Associated complications include impairment in the cardiovascular and cerebrovascular, neurological and endocrine systems. There is growing concern that the perioperative period may acutely worsen existing OSA or potentially induce sleep disordered breathing in susceptible individuals. Indeed, the presence of OSA has been shown to be an independent risk factor for perioperative complications. The mechanism for this perioperative risk, however, has yet to be fully elucidated.
This study proposes to investigate the relationship between surgical anesthesia and OSA with an observational prospective single-blinded investigation. A sample of 600 adult female and male orthopedic surgery patients scheduled for elective ambulatory orthopedic surgery at WRNMMC will be enrolled. Study subjects shall undergo an unattended Home Sleep Test (HST) the night before surgery followed by surgery and anesthesia as determined by the surgical team unchanged by study participation. Following the surgical procedure and anesthesia, the study subject will undergo a series of two additional HSTs on the first night following surgery and again on post-operative night three and complete a postoperative questionnaire including a validated screening questionnaire and information pertaining to postoperative pain and medication use.
Qualitative and quantitative analysis will be performed on the data. The prevalence in the ambulatory orthopedic population of screening positive with the STOP-BANG questionnaire, a validated Obstructive Sleep Apnea (OSA) screening tool, will be determined as well as the prevalence of OSA diagnosed by the preoperative Home Sleep Test (HST). The analysis of the HST data will be blinded as to OSA status, if known, and screening results using the validated "STOP-BANG" screening questionnaire. There are several additional research questions posed in this observational prospective single-blinded clinical study to determine if OSA, as defined by apnea-hypopnea index (AHI), is a significant factor in adverse events associated with ambulatory orthopedic surgery. First, a study sample size of 600 was selected to provide 82% power to detect a significant difference in unplanned admissions between patients with OSA (estimated at 20% of the surgical orthopedic population) and without OSA. This assumes 10% of patients without OSA experience unplanned admissions compared with 20% of patients with OSA. Other adverse perioperative events to be examined include difficult intubations, upper airway obstruction after extubation, bronchospasm, laryngospasm, arrhythmia such as atrial fibrillation, and need for mechanical ventilation
Additional questions to be examined include if surgery and anesthesia, the specific anesthetic technique, intraoperative sedative use, or postoperative sedative use is associated with any Home Sleep Test (HST) parameter (AHI, Oxygen Desaturation Index (ODI), pulse oximetry (SpO2) nadir, or percentage of time SpO2<90%). Paired t-tests will be used to perform the analyses except for the question of anesthetic technique for which analysis of variance followed by Tukey's post-hoc multiple comparisons will be employed.
Lastly is the clinically relevant question addressing whether there is a difference between patients who screen as high risk for OSA and those who screen as low risk for OSA with regard to pre and postoperative AHI, ODI, SpO2 nadir, or percentage of time SpO2<90%? High- and low-risk patients per the screening instrument will be compared using t-tests for independent samples.
Ultimately understanding the relationship between surgical anesthesia and OSA may be used to risk stratify patients, identify those at an increased risk for perioperative complications, or potentially aid in determining perioperative management plans.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ambulatory orthopedic surgery patients with OSA | – | Other: Home sleep test administered to all enrolled subjectsambulatory orthopedic surgery patients with home sleep test preoperative AHI => 5 |
| ambulatory orthopedic surgery patients without OSA | – | Other: Home sleep test administered to all enrolled subjectsambulatory orthopedic surgery patients with home sleep test preoperative AHI < 5 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ambulatory orthopedic surgery patients presenting to Walter Reed National Military Medical Center
Key inclusion criteria (4 listed)
- Male and female military health care beneficiaries between the ages of 18 and 85 years presenting for elective ambulatory orthopedic surgery at WRNMMC main operating room.
- American Society of Anesthesiologist physical classification (ASA) I-II
- Scheduled for elective ambulatory orthopedic surgery
- Patients English speaking and capable of providing informed consent.
Key exclusion criteria (6 listed)
- Patients who are pregnant or breast-feeding at the time of the procedure. Pregnancy will be ruled out by day of surgery urine human chorionic gonadotropin (HCG) when appropriate.
- Chronic opioid, benzodiazepine, pregabalin, or other sedating medication users
- Chronic alcohol users (defined by daily or greater use upon standard anesthesia preoperative interview)
- Patients who require home oxygen use
- Patients who have a tracheostomy
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 |
|---|---|---|
| Home sleep test administered to all enrolled subjects | Other | ambulatory orthopedic surgery patients with OSA, ambulatory orthopedic surgery patients without OSA |
Primary outcome
Unplanned hospital admission
Time frame: First three post operative days
1 secondary outcome
Prevalence of OSA in orthopedic ambulatory surgical population
Time frame: Determined by home sleep test on night before surgery over study duration expected to be 2-3 years
Results and safety
The study was stopped early (reason given: Staffing changes precluded sleep study interpretation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2015.
- Derived from this study: PubMed 29609705Hudson AJ, Walter RJ, Flynn J, Szpisjak DF, Olsen C, Rodgers M, Capaldi VF 2nd, McDuffie B, Lettieri CJ. Ambulatory Surgery Has Minimal Impact on Sleep Parameters: A Prospective Observational Trial. J Clin Sleep Med. 2018 Apr 15;14(4):593-602. doi: 10.5664/jcsm.7052.
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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.
Arlene Hudson, MD principal investigator
Walter Reed National Military Medical Center and Uniformed Services University of the Health Sciences
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 Sleep Disordered Breathing, run by Walter Reed National Military Medical Center 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 6 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: stopped early, as of the sponsor's last update on 15 Dec 2015. 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 stopped early (reason given: Staffing changes precluded sleep study interpretation). Results are not available in the source record.
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?
Unplanned hospital admission (time frame: First three post operative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01851798, which also lists 1 linked publication.
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 15 Dec 2015.