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

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

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

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea (OSA)
• Intervention / Treatment: Device: Audiovisual Distraction

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Audiovisual Distraction; watching a movie using video glasses and headphones; Other Names: Audiovisual Aids; Zeiss Cinemizer OLED Glasses; HappyMed Video Glasses
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Desaturations	number of desaturation events (SpO2< 90% for ≥ 10 sec) measured during this time frame	start of anesthesia until 30 minutes after recovery room admission (ca. 3 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	start of anesthesia until 30 minutes after recovery room admission (ca. 3 hours)
Additional Sedation	Patient request for additional sedation	intraoperative
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).	10 minutes before recovery room discharge
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.	4 times: preoperative, intraoperative, at time of recovery room admission, 10 minutes before recovery room discharge

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York
• Investigators: Principal Investigator: Stavros G Memtsoudis, MD, PhD, Hospital for Special Surgery, New York

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: January 4, 2017
• First Submitted That Met QC Criteria: January 11, 2017
• First Posted (Estimate): January 13, 2017

Study Record Updates

• Last Update Posted (Actual): May 6, 2022
• Last Update Submitted That Met QC Criteria: May 5, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Sympathomimetics; Adrenergic Uptake Inhibitors; Methamphetamine
• Other Study ID Numbers: 2016-0648

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO