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

Primary Purpose

Obstructive Sleep Apnea (OSA)

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Audiovisual Distraction
Sponsored by
Hospital for Special Surgery, New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obstructive Sleep Apnea (OSA)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Audiovisual Distraction

    Standard of care sedation

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    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.
    Additional Sedation
    Patient request for additional sedation
    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).
    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.

    Full Information

    First Posted
    January 4, 2017
    Last Updated
    May 5, 2022
    Sponsor
    Hospital for Special Surgery, New York
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03020914
    Brief Title
    Effects of Audiovisual Distraction on Desaturation and Airway Intervention in OSA-patients
    Acronym
    AVD
    Official Title
    Effects of Audiovisual Distraction Versus Standard Sedation on Desaturation and Airway Intervention in OSA-patients Undergoing Total Knee Arthroplasty Under Neuraxial Anesthesia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2017 (undefined)
    Primary Completion Date
    May 2019 (Actual)
    Study Completion Date
    May 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hospital for Special Surgery, New York

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Patients will be randomly assigned to either one of two groups: Standard of care sedation 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. Standard of care sedation with an initial dose of midazolam in preparation for the administration of the neuraxial anesthesia; propofol infusion titrated to effect. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obstructive Sleep Apnea (OSA)

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    19 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Audiovisual Distraction
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Standard of care sedation
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Audiovisual Distraction
    Other Intervention Name(s)
    Audiovisual Aids, Zeiss Cinemizer OLED Glasses, HappyMed Video Glasses
    Intervention Description
    watching a movie using video glasses and headphones
    Primary Outcome Measure Information:
    Title
    Desaturations
    Description
    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)
    Secondary Outcome Measure Information:
    Title
    Airway Interventions
    Description
    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)
    Title
    Additional Sedation
    Description
    Patient request for additional sedation
    Time Frame
    intraoperative
    Title
    Patient Satisfaction
    Description
    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
    Title
    Alertness Levels
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Stavros G Memtsoudis, MD, PhD
    Organizational Affiliation
    Hospital for Special Surgery, New York
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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