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

NCT03020914 | Completed Results

• 1 other identifier: 2016-0648
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients will be randomly assigned to either one of two groups:

1. 1.Standard of care sedation
2. 2.Audiovisual distraction during surgery and in the recovery room using video goggles and headphones; patients can choose a movie from a preexisting library

Conditions

Obstructive Sleep Apnea (OSA)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Airway Interventions

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

• Additional Sedation

  intraoperative

• Patient Satisfaction

  10 minutes before recovery room discharge

• Alertness Levels

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

Study Arms (2)

Audiovisual Distraction

EXPERIMENTAL

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

Standard of care sedation

NO INTERVENTION

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.

Interventions

Audiovisual Distraction DEVICE

watching a movie using video glasses and headphones

Also known as: Audiovisual Aids, Zeiss Cinemizer OLED Glasses, HappyMed Video Glasses

Audiovisual Distraction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Marla Sharp, MPH, MA
• Organization: Hospital for Special Surgery

sharpm@hss.edu

646-797-8419

Study Officials

• Stavros G Memtsoudis, MD, PhD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: January 13, 2017
• Study Start: January 1, 2017
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: May 6, 2022
• Results First Posted: May 6, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share