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Assessment of an Endotracheal Tube Securement Device

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ClinicalTrials.gov Identifier: NCT01651260
Recruitment Status : Completed
First Posted : July 27, 2012
Results First Posted : October 28, 2015
Last Update Posted : March 23, 2016
Sponsor:
Information provided by (Responsible Party):
Hollister Incorporated

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition: Respiratory Insufficiency
Intervention: Other: Experimental ET Tube Securement Device

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited between July 2012 to February 2013 in the ICU setting at 6 hospitals.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Hollister ET Tube Securement Device Hollister endotracheal tube securement device : Subjects wear one Hollister ET tube securement device until the device either needs to be changed or is no longer required by the subject.

Participant Flow:   Overall Study
    Hollister ET Tube Securement Device
STARTED   65 
COMPLETED   62 
NOT COMPLETED   3 
unable to apply product                3 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Complete demographic profiles were obtained for 63 participants

Reporting Groups
  Description
Hollister ET Tube Securement Device Hollister endotracheal tube securement device: Subjects wear one Hollister ET tube securement device until the device either needs to be changed or is no longer required by the subject.

Baseline Measures
   Hollister ET Tube Securement Device 
Overall Participants Analyzed 
[Units: Participants]
 63 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.8  (15.6) 
Gender 
[Units: Participants]
 
Female   28 
Male   35 
Reason for intubation 
[Units: Participants]
 
Respiratory Failure   55 
Post-operative   3 
Other   5 


  Outcome Measures

1.  Primary:   Prevention of Damage and/or Occlusion of Endotracheal (ET) Tube During Use   [ Time Frame: 14 days ]

2.  Secondary:   Ease of Use   [ Time Frame: Between 1 - 14 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Adult subjects in respiratory insufficiency in ICU setting were intubated with only four ET tube sizes: 7.0, 7.5, 8.0 and 8.5 mm. No other sizes were represented in the sample population.


  More Information

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 agreement is:
unchecked 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Malford Cullum
Organization: Hollister Incorporated
phone: 847-918-3975
e-mail: malford.cullum@Hollister.com



Responsible Party: Hollister Incorporated
ClinicalTrials.gov Identifier: NCT01651260     History of Changes
Other Study ID Numbers: 5156-I
First Submitted: July 16, 2012
First Posted: July 27, 2012
Results First Submitted: March 18, 2014
Results First Posted: October 28, 2015
Last Update Posted: March 23, 2016