Trial Outcomes & Findings for Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) and Laser Laryngeal Surgery (NCT NCT03086265)
NCT ID: NCT03086265
Last Updated: 2020-03-17
Results Overview
Peripheral oxygen saturation is an estimate of the amount of oxygen in the blood.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Duration of surgery (average approximately 1 hour)
Results posted on
2020-03-17
Participant Flow
Participant milestones
| Measure |
THRIVE
Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
|
Endotracheal Tube
Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
THRIVE
n=10 Participants
Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
|
Endotracheal Tube
n=10 Participants
Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 15 • n=10 Participants
|
52 years
STANDARD_DEVIATION 12 • n=10 Participants
|
53 years
STANDARD_DEVIATION 13 • n=20 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=10 Participants
|
6 Participants
n=10 Participants
|
14 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=10 Participants
|
4 Participants
n=10 Participants
|
6 Participants
n=20 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants
|
10 participants
n=10 Participants
|
20 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Duration of surgery (average approximately 1 hour)Peripheral oxygen saturation is an estimate of the amount of oxygen in the blood.
Outcome measures
| Measure |
THRIVE
n=10 Participants
Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
|
Endotracheal Tube
n=10 Participants
Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
|
|---|---|---|
|
Lowest Intraoperative Peripheral Oxygen Saturation (SpO2)
|
97 percentage of oxygen
Standard Deviation 2
|
97 percentage of oxygen
Standard Deviation 3
|
PRIMARY outcome
Timeframe: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour), recovery room (approximately 1 hour)Population: This outcome was assessed in THRIVE participants only. Participants with measurements at each respective time point are included in the analysis.
Outcome measures
| Measure |
THRIVE
n=10 Participants
Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
|
Endotracheal Tube
Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
|
|---|---|---|
|
Partial Pressure of Oxygen in the Arterial Blood (PaO2)
Induction
|
365 mmHg
Standard Deviation 40
|
—
|
|
Partial Pressure of Oxygen in the Arterial Blood (PaO2)
10 minutes post-induction
|
294 mmHg
Standard Deviation 79
|
—
|
|
Partial Pressure of Oxygen in the Arterial Blood (PaO2)
20 minutes post-induction
|
279 mmHg
Standard Deviation 81
|
—
|
|
Partial Pressure of Oxygen in the Arterial Blood (PaO2)
30 minutes post-induction
|
245 mmHg
Standard Deviation 81
|
—
|
|
Partial Pressure of Oxygen in the Arterial Blood (PaO2)
40 minutes post-induction
|
223 mmHg
Standard Deviation 67
|
—
|
|
Partial Pressure of Oxygen in the Arterial Blood (PaO2)
Spontaneous ventilation
|
251 mmHg
Standard Deviation 102
|
—
|
|
Partial Pressure of Oxygen in the Arterial Blood (PaO2)
Recovery room
|
86 mmHg
Standard Deviation 13
|
—
|
PRIMARY outcome
Timeframe: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour), recovery room (approximately 1 hour)Population: This outcome was assessed in THRIVE participants only. Participants with measurements at each respective time point are included in the analysis.
Outcome measures
| Measure |
THRIVE
n=10 Participants
Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
|
Endotracheal Tube
Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
|
|---|---|---|
|
Partial Pressure of Carbon Dioxide in the Arterial Blood (PaCO2)
Induction
|
32 mmHg
Standard Deviation 5
|
—
|
|
Partial Pressure of Carbon Dioxide in the Arterial Blood (PaCO2)
10 minutes post-induction
|
54 mmHg
Standard Deviation 5
|
—
|
|
Partial Pressure of Carbon Dioxide in the Arterial Blood (PaCO2)
20 minutes post-induction
|
65 mmHg
Standard Deviation 9
|
—
|
|
Partial Pressure of Carbon Dioxide in the Arterial Blood (PaCO2)
30 minutes post-induction
|
77 mmHg
Standard Deviation 8
|
—
|
|
Partial Pressure of Carbon Dioxide in the Arterial Blood (PaCO2)
40 minutes post-induction
|
86 mmHg
Standard Deviation 7
|
—
|
|
Partial Pressure of Carbon Dioxide in the Arterial Blood (PaCO2)
Spontaneous ventilation
|
71 mmHg
Standard Deviation 13
|
—
|
|
Partial Pressure of Carbon Dioxide in the Arterial Blood (PaCO2)
Recovery room
|
37 mmHg
Standard Deviation 5
|
—
|
PRIMARY outcome
Timeframe: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour), recovery room (approximately 1 hour)Population: This outcome was assessed in THRIVE participants only. Participants with measurements at each respective time point are included in the analysis.
The pH range is 0 to 14, with 7 being neutral. A pH of less than 7 indicate acidity, whereas a pH of greater than 7 indicates a base.
Outcome measures
| Measure |
THRIVE
n=10 Participants
Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
|
Endotracheal Tube
Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
|
|---|---|---|
|
pH in Blood
Induction
|
7.4 pH
Standard Deviation 0
|
—
|
|
pH in Blood
10 minutes post-induction
|
7.2 pH
Standard Deviation 0
|
—
|
|
pH in Blood
20 minutes post-induction
|
7.2 pH
Standard Deviation 0
|
—
|
|
pH in Blood
30 minutes post-induction
|
7.1 pH
Standard Deviation 0
|
—
|
|
pH in Blood
40 minutes post-induction
|
7.1 pH
Standard Deviation 0.1
|
—
|
|
pH in Blood
Spontaneous ventilation
|
7.4 pH
Standard Deviation 0.1
|
—
|
|
pH in Blood
Recovery room
|
7.4 pH
Standard Deviation 0
|
—
|
PRIMARY outcome
Timeframe: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)Population: Participants with measurements at each respective time point are included in the analysis.
Outcome measures
| Measure |
THRIVE
n=10 Participants
Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
|
Endotracheal Tube
n=10 Participants
Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
|
|---|---|---|
|
Heart Rate
30 minutes post-induction
|
79 beats per minute
Standard Deviation 14
|
76 beats per minute
Standard Deviation 12
|
|
Heart Rate
Induction
|
65 beats per minute
Standard Deviation 11
|
70 beats per minute
Standard Deviation 15
|
|
Heart Rate
10 minutes post-induction
|
72 beats per minute
Standard Deviation 12
|
81 beats per minute
Standard Deviation 14
|
|
Heart Rate
20 minutes post-induction
|
79 beats per minute
Standard Deviation 13
|
79 beats per minute
Standard Deviation 9
|
|
Heart Rate
40 minutes post-induction
|
81 beats per minute
Standard Deviation 15
|
73 beats per minute
Standard Deviation 9
|
|
Heart Rate
Spontaneous ventilation
|
72 beats per minute
Standard Deviation 14
|
71 beats per minute
Standard Deviation 15
|
PRIMARY outcome
Timeframe: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)Population: Participants with measurements at each respective time point are included in the analysis.
Outcome measures
| Measure |
THRIVE
n=10 Participants
Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
|
Endotracheal Tube
n=10 Participants
Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
|
|---|---|---|
|
Mean Arterial Pressure (MAP)
Induction
|
90 mmHg
Standard Deviation 16
|
92 mmHg
Standard Deviation 12
|
|
Mean Arterial Pressure (MAP)
10 minutes post-induction
|
78 mmHg
Standard Deviation 12
|
76 mmHg
Standard Deviation 9
|
|
Mean Arterial Pressure (MAP)
20 minutes post-induction
|
71 mmHg
Standard Deviation 9
|
83 mmHg
Standard Deviation 17
|
|
Mean Arterial Pressure (MAP)
30 minutes post-induction
|
72 mmHg
Standard Deviation 12
|
85 mmHg
Standard Deviation 13
|
|
Mean Arterial Pressure (MAP)
40 minutes post-induction
|
69 mmHg
Standard Deviation 13
|
80 mmHg
Standard Deviation 12
|
|
Mean Arterial Pressure (MAP)
Spontaneous ventilation
|
88 mmHg
Standard Deviation 14
|
88 mmHg
Standard Deviation 18
|
PRIMARY outcome
Timeframe: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)Population: Participants with measurements at each respective time point are included in the analysis.
Stroke volume - the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the body surface area (BSA) (m\^2).
Outcome measures
| Measure |
THRIVE
n=10 Participants
Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
|
Endotracheal Tube
n=10 Participants
Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
|
|---|---|---|
|
Stroke Volume Index (SVI)
Induction
|
50 ml/b/m^2
Standard Deviation 10
|
48 ml/b/m^2
Standard Deviation 13
|
|
Stroke Volume Index (SVI)
10 minutes post-induction
|
45 ml/b/m^2
Standard Deviation 7
|
36 ml/b/m^2
Standard Deviation 7
|
|
Stroke Volume Index (SVI)
20 minutes post-induction
|
48 ml/b/m^2
Standard Deviation 10
|
35 ml/b/m^2
Standard Deviation 6
|
|
Stroke Volume Index (SVI)
30 minutes post-induction
|
51 ml/b/m^2
Standard Deviation 12
|
39 ml/b/m^2
Standard Deviation 9
|
|
Stroke Volume Index (SVI)
40 minutes post-induction
|
52 ml/b/m^2
Standard Deviation 6
|
43 ml/b/m^2
Standard Deviation 10
|
|
Stroke Volume Index (SVI)
Spontaneous ventilation
|
54 ml/b/m^2
Standard Deviation 17
|
53 ml/b/m^2
Standard Deviation 12
|
PRIMARY outcome
Timeframe: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)Population: Participants with measurements at each respective time point are included in the analysis.
Cardiac index: A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m\^2) to yield the cardiac index.
Outcome measures
| Measure |
THRIVE
n=10 Participants
Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
|
Endotracheal Tube
n=10 Participants
Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
|
|---|---|---|
|
Cardiac Index (CI)
Induction
|
3.2 L/min/m^2
Standard Deviation 0.7
|
3.4 L/min/m^2
Standard Deviation 0.9
|
|
Cardiac Index (CI)
10 minutes post-induction
|
3.2 L/min/m^2
Standard Deviation 0.7
|
3.0 L/min/m^2
Standard Deviation 0.7
|
|
Cardiac Index (CI)
20 minutes post-induction
|
3.7 L/min/m^2
Standard Deviation 0.5
|
2.8 L/min/m^2
Standard Deviation 0.5
|
|
Cardiac Index (CI)
30 minutes post-induction
|
3.9 L/min/m^2
Standard Deviation 0.7
|
3.0 L/min/m^2
Standard Deviation 0.6
|
|
Cardiac Index (CI)
40 minutes post-induction
|
4.2 L/min/m^2
Standard Deviation 0.8
|
3.1 L/min/m^2
Standard Deviation 0.7
|
|
Cardiac Index (CI)
Spontaneous ventilation
|
3.7 L/min/m^2
Standard Deviation 0.9
|
3.6 L/min/m^2
Standard Deviation 0.6
|
PRIMARY outcome
Timeframe: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)Population: Participants with measurements at each respective time point are included in the analysis.
SVRI equals systemic vascular resistance (SVR) times BSA. SVR is the resistance to blood flow through the systemic circulation and it was measured in Wood units. Wood unit =80 dyne\*seconds per centimetre\^5 (dyne\*sec/cm\^5).
Outcome measures
| Measure |
THRIVE
n=10 Participants
Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
|
Endotracheal Tube
n=10 Participants
Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
|
|---|---|---|
|
Systemic Vascular Resistance Index (SVRI)
Induction
|
2249 dynes*s/cm^5/m^2
Standard Deviation 652
|
2140 dynes*s/cm^5/m^2
Standard Deviation 443
|
|
Systemic Vascular Resistance Index (SVRI)
10 minutes post-induction
|
1769 dynes*s/cm^5/m^2
Standard Deviation 549
|
2026 dynes*s/cm^5/m^2
Standard Deviation 446
|
|
Systemic Vascular Resistance Index (SVRI)
20 minutes post-induction
|
1341 dynes*s/cm^5/m^2
Standard Deviation 321
|
2182 dynes*s/cm^5/m^2
Standard Deviation 440
|
|
Systemic Vascular Resistance Index (SVRI)
30 minutes post-induction
|
1330 dynes*s/cm^5/m^2
Standard Deviation 464
|
2080 dynes*s/cm^5/m^2
Standard Deviation 446
|
|
Systemic Vascular Resistance Index (SVRI)
40 minutes post-induction
|
1130 dynes*s/cm^5/m^2
Standard Deviation 217
|
1187 dynes*s/cm^5/m^2
Standard Deviation 530
|
|
Systemic Vascular Resistance Index (SVRI)
Spontaneous ventilation
|
1841 dynes*s/cm^5/m^2
Standard Deviation 443
|
2152 dynes*s/cm^5/m^2
Standard Deviation 578
|
PRIMARY outcome
Timeframe: Duration of surgery (average approximately 1 hour)Recorded from the end of surgery until the return of patient's protective airway reflexes and patient opening eyes to command.
Outcome measures
| Measure |
THRIVE
n=10 Participants
Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
|
Endotracheal Tube
n=10 Participants
Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
|
|---|---|---|
|
Awakening/Extubation Time
|
14 minutes
Standard Deviation 3
|
13 minutes
Standard Deviation 6
|
PRIMARY outcome
Timeframe: Duration of surgery (average approximately 1 hour)Recorded from the moment of the introduction of the operating laryngoscope in patient's mouth to full surgical suspension.
Outcome measures
| Measure |
THRIVE
n=10 Participants
Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
|
Endotracheal Tube
n=10 Participants
Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
|
|---|---|---|
|
Time to Suspension
|
4 minutes
Standard Deviation 2
|
3 minutes
Standard Deviation 2
|
PRIMARY outcome
Timeframe: Duration of surgery (average approximately 1 hour)Number of adjustments of the suspension laryngoscope.
Outcome measures
| Measure |
THRIVE
n=10 Participants
Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
|
Endotracheal Tube
n=10 Participants
Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
|
|---|---|---|
|
Number of Suspension Adjustments
|
1 adjustments
Standard Deviation 1
|
2 adjustments
Standard Deviation 4
|
PRIMARY outcome
Timeframe: Duration of surgery (average approximately 1 hour)Recorded from the moment of the introduction of the operating laryngoscope in patient's mouth to withdrawing the laryngoscope at the completion of surgery.
Outcome measures
| Measure |
THRIVE
n=10 Participants
Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
|
Endotracheal Tube
n=10 Participants
Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
|
|---|---|---|
|
Duration of Surgery
|
61 minutes
Standard Deviation 29
|
57 minutes
Standard Deviation 44
|
SECONDARY outcome
Timeframe: Duration of surgery (average approximately 1 hour)Jet ventilation refers to delivery of oxygen via high pressure jet ventilator.
Outcome measures
| Measure |
THRIVE
n=10 Participants
Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
|
Endotracheal Tube
n=10 Participants
Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
|
|---|---|---|
|
Count of Participants Requiring Jet Ventilation
|
7 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Duration of surgery (average approximately 1 hour)Recorded from the discontinuation of anesthetic drugs to the return of patient's spontaneous ventilation.
Outcome measures
| Measure |
THRIVE
n=10 Participants
Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
|
Endotracheal Tube
n=10 Participants
Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
|
|---|---|---|
|
Time to Spontaneous Ventilation
|
5 minutes
Standard Deviation 4
|
11 minutes
Standard Deviation 5
|
SECONDARY outcome
Timeframe: Duration of surgery (average approximately 1 hour)Recorded from induction of anesthesia to the return of spontaneous ventilation.
Outcome measures
| Measure |
THRIVE
n=10 Participants
Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
|
Endotracheal Tube
n=10 Participants
Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
|
|---|---|---|
|
Apnea Time
|
70 minutes
Standard Deviation 28
|
87 minutes
Standard Deviation 48
|
SECONDARY outcome
Timeframe: Duration of surgery (average approximately 1 hour)Recorded from induction of anesthesia to patient's awakening/extubation
Outcome measures
| Measure |
THRIVE
n=10 Participants
Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
|
Endotracheal Tube
n=10 Participants
Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
|
|---|---|---|
|
Duration of Anesthesia
|
78 minutes
Standard Deviation 28
|
89 minutes
Standard Deviation 48
|
SECONDARY outcome
Timeframe: Duration of surgery (average approximately 1 hour)Outcome measures
| Measure |
THRIVE
n=10 Participants
Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
|
Endotracheal Tube
n=10 Participants
Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
|
|---|---|---|
|
Total Propofol Dose (Anesthetic)
|
730 mg
Standard Deviation 288
|
920 mg
Standard Deviation 388
|
SECONDARY outcome
Timeframe: Duration of surgery (average approximately 1 hour)Outcome measures
| Measure |
THRIVE
n=10 Participants
Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
|
Endotracheal Tube
n=10 Participants
Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
|
|---|---|---|
|
Total Remifentanil Dose (Anesthetic)
|
996 µg
Standard Deviation 674
|
1114 µg
Standard Deviation 432
|
SECONDARY outcome
Timeframe: Duration of surgery (average approximately 1 hour)Population: Participants who received phenylephrine are included in the analysis.
Outcome measures
| Measure |
THRIVE
n=6 Participants
Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
|
Endotracheal Tube
n=4 Participants
Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
|
|---|---|---|
|
Total Phenylephrine Dose (Vasoactive Drug)
|
300 mg
Standard Deviation 591
|
479 mg
Standard Deviation 757
|
SECONDARY outcome
Timeframe: Duration of surgery (average approximately 1 hour)Population: Participants who received ephedrine are included in the analysis.
Outcome measures
| Measure |
THRIVE
n=3 Participants
Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
|
Endotracheal Tube
n=2 Participants
Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
|
|---|---|---|
|
Total Ephedrine Dose (Vasoactive Drug)
|
4 mg
Standard Deviation 8
|
1 mg
Standard Deviation 2
|
SECONDARY outcome
Timeframe: Duration of surgery (average approximately 1 hour)Population: Participants who received labetalol are included in the analysis.
Outcome measures
| Measure |
THRIVE
n=3 Participants
Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
|
Endotracheal Tube
n=6 Participants
Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
|
|---|---|---|
|
Total Labetalol Dose (Vasoactive Drug)
|
15 mg
Standard Deviation 22
|
13 mg
Standard Deviation 21
|
SECONDARY outcome
Timeframe: Duration of surgery (average approximately 1 hour)Recorded from patient's admission to the recovery room to patient's orientation to person, place, time, and situation as assessed by the recovery room nurse.
Outcome measures
| Measure |
THRIVE
n=10 Participants
Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
|
Endotracheal Tube
n=10 Participants
Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
|
|---|---|---|
|
Time to Patient Being Alert and Oriented x 4
|
23 minutes
Standard Deviation 29
|
23 minutes
Standard Deviation 19
|
SECONDARY outcome
Timeframe: Duration of recovery room stay (average approximately 1 hour)From admission to recovery room, to discharge from recovery room
Outcome measures
| Measure |
THRIVE
n=10 Participants
Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
|
Endotracheal Tube
n=10 Participants
Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
|
|---|---|---|
|
Recovery Room Discharge-ready Time
|
64 minutes
Standard Deviation 18
|
62 minutes
Standard Deviation 12
|
SECONDARY outcome
Timeframe: Duration of recovery room stay (average approximately 1 hour)Pain scale was 0-10 (0 = no pain, 10 - worst pain imaginable).
Outcome measures
| Measure |
THRIVE
n=10 Participants
Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
|
Endotracheal Tube
n=10 Participants
Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
|
|---|---|---|
|
First Pain Score in Recovery Room
|
2 score on a scale
Standard Deviation 4
|
3 score on a scale
Standard Deviation 3
|
SECONDARY outcome
Timeframe: Duration of recovery room stay (average approximately 1 hour)Pain scale was 0-10 (0 = no pain, 10 - worst pain imaginable).
Outcome measures
| Measure |
THRIVE
n=10 Participants
Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
|
Endotracheal Tube
n=10 Participants
Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
|
|---|---|---|
|
Pain Score at Discharge From Recovery Room
|
3 score on a scale
Standard Deviation 2
|
2 score on a scale
Standard Deviation 2
|
SECONDARY outcome
Timeframe: Recovery room to 7th postoperative dayAnalgesic consumption was measured in oral morphine milligram equivalents (MME)
Outcome measures
| Measure |
THRIVE
n=10 Participants
Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
|
Endotracheal Tube
n=10 Participants
Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
|
|---|---|---|
|
Analgesic Consumption
|
12 MME
Standard Deviation 17
|
8 MME
Standard Deviation 7
|
SECONDARY outcome
Timeframe: Prior to procedure, and 1-2 hours after procedureThe QoR15 has 15 questions each is on a scale of 0-10 to measure patient functionality. Scores are summed for an overall range of 0-150, with higher scores corresponding to better recovery.
Outcome measures
| Measure |
THRIVE
n=10 Participants
Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
|
Endotracheal Tube
n=10 Participants
Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
|
|---|---|---|
|
Quality of Recovery (QoR)15 Score
Preoperative
|
135 score on a scale
Standard Deviation 17
|
138 score on a scale
Standard Deviation 8
|
|
Quality of Recovery (QoR)15 Score
Postoperative
|
146 score on a scale
Standard Deviation 5
|
136 score on a scale
Standard Deviation 11
|
Adverse Events
THRIVE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Endotracheal Tube
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place