Trial Outcomes & Findings for Effects of Audiovisual Distraction on Desaturation and Airway Intervention in OSA-patients (NCT NCT03020914)

NCT ID: NCT03020914

Last Updated: 2022-05-06

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 19 participants
• Primary outcome timeframe: start of anesthesia until 30 minutes after recovery room admission (ca. 3 hours)
• Results posted on: 2022-05-06

Participant Flow

Participant milestones

Measure	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	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.
Overall Study STARTED	10	9
Overall Study COMPLETED	9	9
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	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	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.
Overall Study Surgery Cancelled	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Audiovisual Distraction n=10 Participants 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	Standard of Care Sedation n=9 Participants 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.	Total n=19 Participants Total of all reporting groups
Age, Continuous	64 years STANDARD_DEVIATION 8.04 • n=5 Participants	69 years STANDARD_DEVIATION 4.70 • n=7 Participants	66 years STANDARD_DEVIATION 6.99 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	9 participants n=7 Participants	19 participants n=5 Participants

PRIMARY outcome

Timeframe: start 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

Outcome measures

Measure	Audiovisual Distraction n=9 Participants 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	Standard of Care Sedation n=9 Participants 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.
Desaturations	0 number of desaturation events Interval 0.0 to 0.0	1 number of desaturation events Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: start 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.

Outcome measures

Measure	Audiovisual Distraction n=9 Participants 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	Standard of Care Sedation n=9 Participants 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.
Airway Interventions	2 airway interventions	7 airway interventions

SECONDARY outcome

Timeframe: intraoperative

Patient request for additional sedation

Outcome measures

Measure	Audiovisual Distraction n=9 Participants 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	Standard of Care Sedation n=9 Participants 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.
Additional Sedation	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 10 minutes before recovery room discharge

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).

Outcome measures

Measure	Audiovisual Distraction n=9 Participants 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	Standard of Care Sedation n=9 Participants 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.
Patient Satisfaction	55 score on a scale Interval 49.0 to 56.0	54 score on a scale Interval 50.0 to 56.0

SECONDARY outcome

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

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.

Outcome measures

Measure	Audiovisual Distraction n=9 Participants 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	Standard of Care Sedation n=9 Participants 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.
Alertness Levels	0 score on a scale Interval 0.0 to 0.0	0 score on a scale Interval 0.0 to 0.0

Adverse Events

Audiovisual Distraction

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care Sedation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Marla Sharp, MPH, MA

Hospital for Special Surgery

Phone: 646-797-8419

Email: sharpm@hss.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place