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Assessment of an Oral Endotracheal Subglottic Tube Holder

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ClinicalTrials.gov Identifier: NCT03328182
Recruitment Status : Completed
First Posted : November 1, 2017
Results First Posted : July 5, 2019
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
Hollister Incorporated

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Intubation
Intervention Device: New oral endotracheal tube holder
Enrollment 34
Recruitment Details  
Pre-assignment Details  
Arm/Group Title New Oral Endotracheal Tube Holder
Hide Arm/Group Description

Single Study Product Arm

New oral endotracheal tube holder: The single arm study product is designed to hold a standard or subglottic ET tube.

Period Title: Overall Study
Started 34
Completed 30
Not Completed 4
Reason Not Completed
Withdrawal by Subject             1
Protocol Violation             2
No Product Evaluated             1
Arm/Group Title New Oral Endotracheal Tube Holder
Hide Arm/Group Description

Single Study Product Arm

New oral endotracheal tube holder: The single arm study product is designed to hold a standard or subglottic ET tube.

Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
Enrolled patients found eligible per Inclusion/Exclusion Criteria
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 30 participants
52.5
(21 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
13
  43.3%
Male
17
  56.7%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
1.Primary Outcome
Title Overall Acceptability With Study Product
Hide Description The overall acceptability relating to general experience with the study product during use will be rated with a 5-point Likert scale ranging from 1=Very Unacceptable to 5=Very Acceptable
Time Frame At product removal (maximum 29 days of patient wearing product)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title New Oral Endotracheal Tube Holder
Hide Arm/Group Description:

Single Study Product Arm

New oral endotracheal tube holder: The single arm study product is designed to hold a standard or subglottic ET tube.

Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
Very Acceptable
13
  43.3%
Acceptable
15
  50.0%
Neither acceptable nor acceptable
0
   0.0%
Unacceptable
2
   6.7%
Very Unacceptable
0
   0.0%
2.Primary Outcome
Title Usability of Study Product
Hide Description The usability of the study product at application and at removal.
Time Frame At application and product removal (maximum 29 days of patient wearing product)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title New Oral Endotracheal Tube Holder
Hide Arm/Group Description:

Single Study Product Arm

New oral endotracheal tube holder: The single arm study product is designed to hold a standard or subglottic ET tube.

Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
Ease of application Very easy to apply
20
  66.7%
Easy to apply
8
  26.7%
Neither easy nor difficult to apply
1
   3.3%
Difficult to apply
1
   3.3%
Very difficult to apply
0
   0.0%
Not Applicable
0
   0.0%
Ease of removal Very easy to apply
18
  60.0%
Easy to apply
7
  23.3%
Neither easy nor difficult to apply
2
   6.7%
Difficult to apply
1
   3.3%
Very difficult to apply
0
   0.0%
Not Applicable
2
   6.7%
Time Frame maximum 29 days of patient wearing product
Adverse Event Reporting Description Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product.
 
Arm/Group Title New Oral Endotracheal Tube Holder
Hide Arm/Group Description

Single Study Product Arm

New oral endotracheal tube holder: The single arm study product is designed to hold a standard or subglottic ET tube.

All-Cause Mortality
New Oral Endotracheal Tube Holder
Affected / at Risk (%)
Total   1/30 (3.33%)    
Hide Serious Adverse Events
New Oral Endotracheal Tube Holder
Affected / at Risk (%) # Events
Total   3/30 (10.00%)    
General disorders   
Oral Bleeding  [1]  1/30 (3.33%)  1
Loose teeth  [2]  1/30 (3.33%)  1
Infections and infestations   
Death  [3]  1/30 (3.33%)  1
Indicates events were collected by systematic assessment
[1]
Patient constantly was biting for over 24 hours after product placement before oral bleeding occurred. Oral bleeding was exacerbated significantly by the heparin drip and other anticoagulation he was on while in the ICU.
[2]
Loose teeth due to prolonged biting, probably NOT related to study device.
[3]
Patient passed due to sepsis progression--not related to device
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
New Oral Endotracheal Tube Holder
Affected / at Risk (%) # Events
Total   1/30 (3.33%)    
Skin and subcutaneous tissue disorders   
Skin lesion  [1]  1/30 (3.33%)  1
Indicates events were collected by systematic assessment
[1]
Skin lesion on patient's skin, below nose, but above upper outer lip. Lesion could be due to a herpetic lesion or an underlying skin condition not previously identified/documented. Investigator indicated AE was probably not related to study device.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 18 months from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director Global Clinical Affairs
Organization: Hollister Incorporated
Phone: 8476802837
EMail: stacy.haddad@hollister.com
Layout table for additonal information
Responsible Party: Hollister Incorporated
ClinicalTrials.gov Identifier: NCT03328182    
Other Study ID Numbers: 5855-I
First Submitted: October 16, 2017
First Posted: November 1, 2017
Results First Submitted: April 11, 2019
Results First Posted: July 5, 2019
Last Update Posted: July 5, 2019