Trial Outcomes & Findings for Improved Patient Recovery After Anesthesia With Hypercapnia Hyperpnoea (NCT NCT00708526)

Results Overview

average time in minutes from the time the surgeon finished closing the surgical incision until the time the investigator in the postoperative care unit determined that the patients meet the discharge criteria from the postoperative anesthesia care unit (their vital signs had been stable for at least 30 min, their pain scores were less than the tolerable pain scores, they could sit up without dizziness or nausea, and their Aldrete score was ≥8).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

up to 2 hours

Results posted on

2022-11-29

Participant Flow

Subjects were recruited from March 28-August 25, 2008 through the surgery schedule at the Moran Eye Center

Participant milestones

Participant milestones
Measure	Quick Emergence Device (QED) At the end of surgery, the Quick Emergence Device was placed between the endotracheal tube and the anesthesia breathing circuit. Minute ventilation was doubled and the end tidal carbon dioxide concentration (EtCO2) was elevated to approximately 48 mmHg.	Standard of Care At the end of surgery, the minute ventilation and EtCO2 remained at normal levels. The Quick Emergence Device was not used.
Wake up After Anesthesia STARTED	11	11
Wake up After Anesthesia COMPLETED	11	11
Wake up After Anesthesia NOT COMPLETED	0	0
Return of Cognitive Function STARTED	11	11
Return of Cognitive Function COMPLETED	11	11
Return of Cognitive Function NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Improved Patient Recovery After Anesthesia With Hypercapnia Hyperpnoea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Quick Emergence Device (QED) n=11 Participants At the end of surgery, the Quick Emergence Device was placed between the endotracheal tube and the anesthesia breathing circuit. Minute ventilation was doubled and the end tidal carbon dioxide concentration (EtCO2) was elevated to approximately 48 mmHg.	Standard of Care n=11 Participants At the end of surgery, the minute ventilation and EtCO2 remained at normal levels. The Quick Emergence Device was not used.	Total n=22 Participants Total of all reporting groups
Age, Continuous Age	43.7 years STANDARD_DEVIATION 15.1 • n=5 Participants	40.4 years STANDARD_DEVIATION 15 • n=7 Participants	42.1 years STANDARD_DEVIATION 15.1 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	11 participants n=7 Participants	22 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 2 hours

average time in minutes from the time the surgeon finished closing the surgical incision until the time the investigator in the postoperative care unit determined that the patients meet the discharge criteria from the postoperative anesthesia care unit (their vital signs had been stable for at least 30 min, their pain scores were less than the tolerable pain scores, they could sit up without dizziness or nausea, and their Aldrete score was ≥8).

Outcome measures

Outcome measures
Measure	Quick Emergence Device (QED) n=11 Participants At the end of surgery, the Quick Emergence Device was placed between the endotracheal tube and the anesthesia breathing circuit. Minute ventilation was doubled and the end tidal carbon dioxide concentration (EtCO2) was elevated to approximately 48 mmHg.	Standard of Care n=11 Participants At the end of surgery, the minute ventilation and EtCO2 remained at normal levels. The Quick Emergence Device was not used.
Recovery From Anesthesia	53.0 minutes Standard Deviation 15.2	62.9 minutes Standard Deviation 28.8

SECONDARY outcome

Timeframe: up to 30 minutes

Population: number of participants determined by protocol

average time in minutes from the time the surgeon finished closing the surgical incision at the end of surgery until the patients could correctly state their full name, the current year and their day, month and year of birth

Outcome measures

Outcome measures
Measure	Quick Emergence Device (QED) n=11 Participants At the end of surgery, the Quick Emergence Device was placed between the endotracheal tube and the anesthesia breathing circuit. Minute ventilation was doubled and the end tidal carbon dioxide concentration (EtCO2) was elevated to approximately 48 mmHg.	Standard of Care n=11 Participants At the end of surgery, the minute ventilation and EtCO2 remained at normal levels. The Quick Emergence Device was not used.
Return of Cognitive Function	10.9 minutes Standard Deviation 5.1	18.2 minutes Standard Deviation 9.7

Adverse Events

Quick Emergence Device (QED)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

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

Dwayne Westenskow, PhD

University of Utah

Phone: 801-581-2478

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place