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

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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:
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard of Care THRIVE
Hide 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
Arm/Group Title Standard of Care THRIVE Total
Hide 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
Hide 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
1.Primary Outcome
Title Number of Surgical Interruptions
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the protocol are included in the analysis
Arm/Group Title Standard of Care THRIVE
Hide 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)
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the protocol are included in the analysis
Arm/Group Title Standard of Care THRIVE
Hide 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)
Hide 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%.
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the protocol are included in the analysis
Arm/Group Title Standard of Care THRIVE
Hide 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)
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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
Hide Description [Not Specified]
Time Frame Up to 12 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the protocol are included in the analysis
Arm/Group Title Standard of Care THRIVE
Hide 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)
Hide 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)
Hide Description Ventilation was measured with transcutaneous carbon dioxide sensor
Time Frame Duration of surgery (generally less than 2 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the protocol are included in the analysis
Arm/Group Title Standard of Care THRIVE
Hide 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)
Hide 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
Hide Description Location of lesion(s) according to post-surgical diagnosis
Time Frame Duration of surgery (generally less than 2 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the protocol are included in the analysis
Arm/Group Title Standard of Care THRIVE
Hide 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
Hide 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
Hide 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
Hide 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
Hide 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
Hide 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
Time Frame Up to 12 hours
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard of Care THRIVE
Hide 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%) 
Hide Serious Adverse Events
Standard of Care THRIVE
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/38 (0.00%) 
Hide 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
Enrollment did not meet the threshold needed for statistical significance
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Thomas Caruso, MD, MEd
Organization: Stanford University
Phone: (626) 275-0341
EMail: tjcaruso@stanford.edu
Publications:
Layout table for additonal information
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