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Effects of Audiovisual Distraction on Desaturation and Airway Intervention in OSA-patients

Effects of Audiovisual Distraction Versus Standard Sedation on Desaturation and Airway Intervention in OSA-patients Undergoing Total Knee Arthroplasty Under Neuraxial Anesthesia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03020914
Acronym
AVD
Enrollment
19
Registered
2017-01-13
Start date
2017-01-31
Completion date
2019-05-31
Last updated
2022-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea (OSA)

Brief summary

Patients will be randomly assigned to either one of two groups: 1. Standard of care sedation 2. Audiovisual distraction during surgery and in the recovery room using video goggles and headphones; patients can choose a movie from a preexisting library Monitoring and anesthesia regimen will be standardized

Detailed description

Before consent patients will be thoroughly informed about possible risks or benefits and about their possibilities to end the study at any time point or to ask for additional sedation if they feel uncomfortable or anxious. After they consent, they will be randomly assigned to either receive standard sedation (Group 1) or audiovisual distraction (Group 2). Each group will consist of 30 patients. The randomization schedule will be created by a member of the Healthcare Research Institute using SAS software, who is not otherwise involved in the trial. 1. Standard of care sedation with an initial dose of midazolam in preparation for the administration of the neuraxial anesthesia; propofol infusion titrated to effect. 2. Audiovisual distraction during surgery and in the recovery room using video goggles and headphones; patients can choose a movie from a preexisting library; with an initial dose of midazolam in preparation for the administration of the neuraxial anesthesia, additional sedation with midazolam in 1 mg increments if requested by the patient or deemed necessary by the anesthesia provider. The intraoperative anesthesia regimen will be standardized: * All patients will be monitored according to the American Society of Anesthesiologists standard, receive either a radial arterial line or non-invasive blood pressure measurement according to the preferences of the anesthesia provider and O2 via nasal cannula or face mask in the operation room and the recovery room. * ondansetron,decadron and ketorolac may be administered as per clinical judgment of the attending anesthesiologist. * Patients in both groups will receive neuraxial anesthesia. The attending anesthesiologist is free to add an ultrasound guided peripheral nerve block: * Neuraxial anesthesia (combined spinal-epidural, epidural or spinal) as preferred by the attending anesthesiologist. Decadron may be used as in addition to the local anesthetic if the anesthesia provider wishes to do so. * If a peripheral nerve block is performed the appropriate amount of bupivacaine will be administered under ultrasound-guidance as a single shot. * In case an epidural catheter was placed patients will receive a patient controlled epidural analgesia immediately after arrival at the recovery room for postoperative pain management. * Opioids and other medications with sedative or respiratory depressant side effects that are not specifically mentioned above should be omitted (if possible without harm for the patient) Patients in the audiovisual distraction group will choose a movie, start watching it in the holding area and continue watching it in the operation room as well as the first 30 min in the recovery room. Audiovisual equipment will be removed for transfers or at patient request.

Interventions

watching a movie using video glasses and headphones

Sponsors

Hospital for Special Surgery, New York
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Patients with known OSA (preexisting diagnosis of obstructive sleep apnea (OSA) or patients with a STOP BANG Score of 5 or above) undergoing primary total knee arthroplasty under neuraxial anesthesia

Exclusion criteria

* Contraindications to neuraxial anesthesia or allergy to study medication * Patients with audiovisual impairments prohibiting them from proper use of the study device: * Patients who are blind * Patients with hearing aids * Age \<18 years * Patients with inability to communicate in English or understand the study requirements * Patients with prior history of claustrophobia * Patients with prior history of epilepsy or seizure disorder * Patients undergoing a revision

Design outcomes

Primary

MeasureTime frameDescription
Desaturationsstart of anesthesia until 30 minutes after recovery room admission (ca. 3 hours)number of desaturation events (SpO2\< 90% for ≥ 10 sec) measured during this time frame

Secondary

MeasureTime frameDescription
Airway Interventionsstart of anesthesia until 30 minutes after recovery room admission (ca. 3 hours)each airway intervention (defined as one of the following: jaw thrust, oropharyngeal airway, nasopharyngeal airway, mask ventilation, larynx mask or intubation) that is implemented during this time frame will be observed and documented by research staff, if it occurs.
Additional SedationintraoperativePatient request for additional sedation
Patient Satisfaction10 minutes before recovery room dischargePatient satisfaction at recovery room discharge as measured by the Heidelberg perianesthetic questionnaire, which assesses patients' peri-anaesthetic satisfaction on a four-point Likert scale ranging from 0 (unimportant to me) to 3 (very important to me). Scores for each question are summed for a final score, with higher total score signifying higher satisfaction and lower total score signifying lower satisfaction. The score scale has a minimum value of 0 and a maximum value of 114 (based off 3 as the highest response score for 38 individual questions).
Alertness Levels4 times: preoperative, intraoperative, at time of recovery room admission, 10 minutes before recovery room dischargeAlertness levels measured using the Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S), which rates alertness on a scale of 0-5, with higher ratings representing increased alertness (e.g. '5 - Responds readily to name spoken in normal tone'). Results reflect a median score of ratings collected at 4 time points.

Participant flow

Participants by arm

ArmCount
Audiovisual Distraction
Patients get audiovisual distraction during surgery and in the recovery room using video goggles and headphones; patients can choose a movie from a preexisting library; with an initial dose of midazolam in preparation for the administration of the neuraxial anesthesia, additional sedation with midazolam in 1 mg increments if requested by the patient or deemed necessary by the anesthesia provider. Audiovisual Distraction: watching a movie using video glasses and headphones
10
Standard of Care Sedation
Standard of care sedation with with a initial dose of midazolam in preparation for the administration of the neuraxial anesthesia; propofol infusion titrated to effect.
9
Total19

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudySurgery Cancelled10

Baseline characteristics

CharacteristicAudiovisual DistractionTotalStandard of Care Sedation
Age, Continuous64 years
STANDARD_DEVIATION 8.04
66 years
STANDARD_DEVIATION 6.99
69 years
STANDARD_DEVIATION 4.7
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants1 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
9 Participants18 Participants9 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
2 Participants2 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants1 Participants0 Participants
Race (NIH/OMB)
White
7 Participants16 Participants9 Participants
Region of Enrollment
United States
10 participants19 participants9 participants
Sex: Female, Male
Female
6 Participants13 Participants7 Participants
Sex: Female, Male
Male
4 Participants6 Participants2 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

Desaturations

number of desaturation events (SpO2\< 90% for ≥ 10 sec) measured during this time frame

Time frame: start of anesthesia until 30 minutes after recovery room admission (ca. 3 hours)

ArmMeasureValue (MEDIAN)
Audiovisual DistractionDesaturations0 number of desaturation events
Standard of Care SedationDesaturations1 number of desaturation events
Secondary

Additional Sedation

Patient request for additional sedation

Time frame: intraoperative

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Audiovisual DistractionAdditional Sedation2 Participants
Standard of Care SedationAdditional Sedation1 Participants
Secondary

Airway Interventions

each airway intervention (defined as one of the following: jaw thrust, oropharyngeal airway, nasopharyngeal airway, mask ventilation, larynx mask or intubation) that is implemented during this time frame will be observed and documented by research staff, if it occurs.

Time frame: start of anesthesia until 30 minutes after recovery room admission (ca. 3 hours)

ArmMeasureValue (NUMBER)
Audiovisual DistractionAirway Interventions2 airway interventions
Standard of Care SedationAirway Interventions7 airway interventions
Secondary

Alertness Levels

Alertness levels measured using the Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S), which rates alertness on a scale of 0-5, with higher ratings representing increased alertness (e.g. '5 - Responds readily to name spoken in normal tone'). Results reflect a median score of ratings collected at 4 time points.

Time frame: 4 times: preoperative, intraoperative, at time of recovery room admission, 10 minutes before recovery room discharge

ArmMeasureValue (MEDIAN)
Audiovisual DistractionAlertness Levels0 score on a scale
Standard of Care SedationAlertness Levels0 score on a scale
Secondary

Patient Satisfaction

Patient satisfaction at recovery room discharge as measured by the Heidelberg perianesthetic questionnaire, which assesses patients' peri-anaesthetic satisfaction on a four-point Likert scale ranging from 0 (unimportant to me) to 3 (very important to me). Scores for each question are summed for a final score, with higher total score signifying higher satisfaction and lower total score signifying lower satisfaction. The score scale has a minimum value of 0 and a maximum value of 114 (based off 3 as the highest response score for 38 individual questions).

Time frame: 10 minutes before recovery room discharge

ArmMeasureValue (MEAN)
Audiovisual DistractionPatient Satisfaction55 score on a scale
Standard of Care SedationPatient Satisfaction54 score on a scale

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026