Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Use in Pediatric Procedures

• ClinicalTrials.gov Identifier: NCT03430206
• Recruitment Status: Completed
• First Posted: February 12, 2018
• Results First Posted: August 6, 2020
• Last Update Posted: August 6, 2020
• Sponsor: Stanford University
• Information provided by (Responsible Party): Thomas Caruso, Stanford University

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Conditions: Oxygen Deficiency; Desaturation of Blood; Hypoventilation; Anesthesia; Adverse Effect
• Intervention: Device: High-flow nasal cannula
• Enrollment: 78

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Standard of Care	THRIVE
Arm/Group Description	Control subjects will undergo their scheduled procedure and recovery with the usual standard care.	Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
Period Title: Overall Study
Started	40	38
Completed	18	21
Not Completed	22	17

Baseline Characteristics

Arm/Group Title		Standard of Care	THRIVE	Total
Arm/Group Description		Control subjects will undergo their scheduled procedure and recovery with the usual standard care.	Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).	Total of all reporting groups
Overall Number of Baseline Participants		18	21	39
Baseline Analysis Population Description		Participants who completed the protocol are included in the analysis
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	18 participants	21 participants	39 participants
		5.1 (4.6)	6.6 (6.2)	5.5 (5.5)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	18 participants	21 participants	39 participants
	Female	6 33.3%	8 38.1%	14 35.9%
	Male	12 66.7%	13 61.9%	25 64.1%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
White	Number Analyzed	18 participants	21 participants	39 participants
		13 72.2%	12 57.1%	25 64.1%
Asian	Number Analyzed	18 participants	21 participants	39 participants
		2 11.1%	3 14.3%	5 12.8%
Unknown/Unreported	Number Analyzed	18 participants	21 participants	39 participants
		3 16.7%	6 28.6%	9 23.1%
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants
United States	Number Analyzed	18 participants	21 participants	39 participants
		18 100.0%	21 100.0%	39 100.0%
Percent Oxygen Saturation [1]; Mean (Standard Deviation); Unit of measure: Percent Saturation
	Number Analyzed	18 participants	18 participants	36 participants
		99.7 (0.6)	99.3 (1.5)	99.5 (1.2)
		[1] Measure Analysis Population Description: 3 participants in the THRIVE group were missing baseline values

Outcome Measures

1. Primary Outcome

Title	Number of Surgical Interruptions
Description	Number of surgical interruptions defined by a pause in surgical procedures due to need to intervene, normalized to case length.
Time Frame	Duration of surgery (generally less than 2 hours)

Outcome Measure Data

Analysis Population Description

Participants who completed the protocol are included in the analysis

Arm/Group Title	Standard of Care	THRIVE
Arm/Group Description:	Control subjects will undergo their scheduled procedure and recovery with the usual standard care.	Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
Overall Number of Participants Analyzed	18	21
Mean (95% Confidence Interval); Unit of Measure: Interruptions
	0.645; (0.308 to 1.35)	0.302; (0.121 to 0.753)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard of Care, THRIVE
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.206
	Comments	[Not Specified]
	Method	Regression, Negative Binomial
	Comments	[Not Specified]

2. Secondary Outcome

Title	Oxygen Desaturation Index
Description	Oxygen desaturation index is defined as the number of times a patient has a 4% decrease in saturation from a 120 second rolling mean for greater than 10 seconds
Time Frame	Duration of surgery (generally less than 2 hours)

Outcome Measure Data

Analysis Population Description

Participants who completed the protocol are included in the analysis

Arm/Group Title	Standard of Care	THRIVE
Arm/Group Description:	Control subjects will undergo their scheduled procedure and recovery with the usual standard care.	Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
Overall Number of Participants Analyzed	18	21
Mean (95% Confidence Interval); Unit of Measure: Events
	1.09; (0.415 to 2.86)	0.312; (0.100 to 0.976)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard of Care, THRIVE
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.101
	Comments	[Not Specified]
	Method	Regression, Negative Binomial
	Comments	[Not Specified]

3. Secondary Outcome

Title	Number of Oxygen Desaturation Events <90% or Defined by a 5% Fall From Baseline if Baseline Saturation < 94%.
Description	Relative incidence of oxygen desaturation as measured by pulse oximetry by second adjusted for post surgical diagnosis
Time Frame	Duration of surgery (generally less than 2 hours)

Outcome Measure Data

Analysis Population Description

Participants who completed the protocol are included in the analysis

Arm/Group Title	Standard of Care	THRIVE
Arm/Group Description:	Control subjects will undergo their scheduled procedure and recovery with the usual standard care.	Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
Overall Number of Participants Analyzed	18	21
Mean (95% Confidence Interval); Unit of Measure: Events
	0.536; (0.195 to 1.473)	0.268; (0.087 to 0.826)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard of Care, THRIVE
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.371
	Comments	[Not Specified]
	Method	Regression, Negative Binomial
	Comments	[Not Specified]

4. Secondary Outcome

Title	Incidence of Oxygen Desaturation
Description	Absolute incidence of oxygen desaturation less than 90% as measured by pulse oximetry by second
Time Frame	Duration of surgery (generally less than 2 hours)

Outcome Measure Data

Analysis Population Description

This outcome measure was removed from the analysis plan during the course of the study.

Arm/Group Title	Standard of Care	THRIVE
Arm/Group Description:	Control subjects will undergo their scheduled procedure and recovery with the usual standard care.	Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

5. Secondary Outcome

Title	Incidence of Adverse Events
Description	[Not Specified]
Time Frame	Up to 12 hours

Outcome Measure Data

Analysis Population Description

Participants who completed the protocol are included in the analysis

Arm/Group Title	Standard of Care	THRIVE
Arm/Group Description:	Control subjects will undergo their scheduled procedure and recovery with the usual standard care.	Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
Overall Number of Participants Analyzed	18	21
Mean (95% Confidence Interval); Unit of Measure: Events
	0.183; (0.061 to 0.547)	0.268; (0.107 to 0.672)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard of Care, THRIVE
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.601
	Comments	[Not Specified]
	Method	Regression, Negative Binomial
	Comments	[Not Specified]

6. Secondary Outcome

Title	End-Tidal Carbon Dioxide (ETCO2)
Description	Ventilation was measured with transcutaneous carbon dioxide sensor
Time Frame	Duration of surgery (generally less than 2 hours)

Outcome Measure Data

Analysis Population Description

Participants who completed the protocol are included in the analysis

Arm/Group Title	Standard of Care	THRIVE
Arm/Group Description:	Control subjects will undergo their scheduled procedure and recovery with the usual standard care.	Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
Overall Number of Participants Analyzed	18	21
Mean (95% Confidence Interval); Unit of Measure: mmHg
	51.6; (46.5 to 56.7)	52.8; (48.2 to 57.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard of Care, THRIVE
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.738
	Comments	[Not Specified]
	Method	Regression, Negative Binomial
	Comments	[Not Specified]

7. Other Pre-specified Outcome

Title	Post-surgical Diagnosis
Description	Location of lesion(s) according to post-surgical diagnosis
Time Frame	Duration of surgery (generally less than 2 hours)

Outcome Measure Data

Analysis Population Description

Participants who completed the protocol are included in the analysis

Arm/Group Title	Standard of Care	THRIVE
Arm/Group Description:	Control subjects will undergo their scheduled procedure and recovery with the usual standard care.	Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
Overall Number of Participants Analyzed	18	21
Measure Type: Count of Participants; Unit of Measure: Participants
Supraglottic	2 11.1%	10 47.6%
Infraglottic	13 72.2%	10 47.6%
Both Supraglottic and Infraglottic	3 16.7%	1 4.8%

8. Other Pre-specified Outcome

Title	Gas Pain or Bloating
Description	Incidence of gas pain or bloating as measured by post-operative survey
Time Frame	Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperatively.

Outcome Measure Data Not Reported

9. Other Pre-specified Outcome

Title	Nasal Irritation
Description	Incidence of nasal irritation as measured by post-operative survey
Time Frame	Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperatively.

Outcome Measure Data Not Reported

10. Other Pre-specified Outcome

Title	Sinus Pressure / Pain
Description	Incidence of sinus pressure and/or pain as measured by post-operative survey
Time Frame	Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperatively.

Outcome Measure Data Not Reported

11. Other Pre-specified Outcome

Title	Headache
Description	Incidence of headache as measured by post-operative survey
Time Frame	Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperatively.

Outcome Measure Data Not Reported

12. Other Pre-specified Outcome

Title	Other Adverse Events
Description	Other adverse events as measured by post-operative survey
Time Frame	Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperatively.

Outcome Measure Data Not Reported

Adverse Events

Time Frame	Up to 12 hours
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Standard of Care	THRIVE
Arm/Group Description	Control subjects will undergo their scheduled procedure and recovery with the usual standard care.	Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
All-Cause Mortality
	Standard of Care	THRIVE
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/40 (0.00%)	0/38 (0.00%)
Serious Adverse Events
	Standard of Care	THRIVE
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/40 (0.00%)	0/38 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Standard of Care	THRIVE
	Affected / at Risk (%)	Affected / at Risk (%)
Total	3/40 (7.50%)	4/38 (10.53%)
Gastrointestinal disorders
Nausea †	2/40 (5.00%)	2/38 (5.26%)
Emesis †	1/40 (2.50%)	0/38 (0.00%)
Respiratory, thoracic and mediastinal disorders
Sinus Pain †	0/40 (0.00%)	1/38 (2.63%)
Nose Bleeding †	0/40 (0.00%)	1/38 (2.63%)
Throat Pain †	0/40 (0.00%)	2/38 (5.26%)
Nasal Pain † [1]	1/40 (2.50%)	0/38 (0.00%)
† Indicates events were collected by systematic assessment; [1] Unconfirmed

Limitations and Caveats

Enrollment did not meet the threshold needed for statistical significance

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Thomas Caruso, MD, MEd
• Organization: Stanford University
• Phone: (626) 275-0341
• EMail: tjcaruso@stanford.edu

Publications:

Humphreys S, Rosen D, Housden T, Taylor J, Schibler A. Nasal high-flow oxygen delivery in children with abnormal airways. Paediatr Anaesth. 2017 Jun;27(6):616-620. doi: 10.1111/pan.13151. Epub 2017 Apr 10.

Doyle AJ, Stolady D, Mariyaselvam M, Wijewardena G, Gent E, Blunt M, Young P. Preoxygenation and apneic oxygenation using Transnasal Humidified Rapid-Insufflation Ventilatory Exchange for emergency intubation. J Crit Care. 2016 Dec;36:8-12. doi: 10.1016/j.jcrc.2016.06.011. Epub 2016 Jun 23.

Mir F, Patel A, Iqbal R, Cecconi M, Nouraei SA. A randomised controlled trial comparing transnasal humidified rapid insufflation ventilatory exchange (THRIVE) pre-oxygenation with facemask pre-oxygenation in patients undergoing rapid sequence induction of anaesthesia. Anaesthesia. 2017 Apr;72(4):439-443. doi: 10.1111/anae.13799. Epub 2016 Dec 30.

Humphreys S, Lee-Archer P, Reyne G, Long D, Williams T, Schibler A. Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) in children: a randomized controlled trial. Br J Anaesth. 2017 Feb;118(2):232-238. doi: 10.1093/bja/aew401.

Gustafsson IM, Lodenius Å, Tunelli J, Ullman J, Jonsson Fagerlund M. Apnoeic oxygenation in adults under general anaesthesia using Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) - a physiological study. Br J Anaesth. 2017 Apr 1;118(4):610-617. doi: 10.1093/bja/aex036.

Desai N, Fowler A. Use of Transnasal Humidified Rapid-Insufflation Ventilatory Exchange for Emergent Surgical Tracheostomy: A Case Report. A A Case Rep. 2017 Nov 1;9(9):268-270. doi: 10.1213/XAA.0000000000000589.

• Responsible Party: Thomas Caruso, Stanford University
• ClinicalTrials.gov Identifier: NCT03430206
• Other Study ID Numbers: IRB-43220
• First Submitted: January 20, 2018
• First Posted: February 12, 2018
• Results First Submitted: July 16, 2020
• Results First Posted: August 6, 2020
• Last Update Posted: August 6, 2020