Endotracheal Tube Intracuff Pressure and Leak

• Sponsor: Kris Jatana (Other)
• Overall Status: Completed
• CT.gov ID: NCT02376179
• Collaborator: (none)
• Enrollment: 84
• Location: 1
• Duration (Months): 22
• Patients Per Site Per Month: 3.8

Study Details

Study Description

Brief Summary

We have devised a simple method to continuously measure the endotracheal tube cuff pressure (CP) using an invasive pressure monitoring setup (IPMS), which is used routinely in the operating room to monitor arterial or central venous pressures. We have previously confirmed both in vitro and in vivo (previous IRB approved protocol), a clinically applicable agreement of the IPMS readings with the values obtained from a standard manometer (gold standard). In the current study, we will prospectively evaluate the relationship between the patient's head position and CP in patients undergoing otolaryngological surgery. A secondary outcome measure is the oxygen or nitrous oxygen concentration in the oropharynx.

Condition or Disease	Intervention/Treatment	Phase
Otolaryngological Surgery	Device: Cuffed ETT

Study Design

• Study Type: Observational
• Actual Enrollment: 84 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Endotracheal Tube Intracuff Pressure and Leak Around the Cuff During Retractor Placement for Tonsillectomy and/or Adenoidectomy
• Study Start Date: Aug 1, 2014
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Cuffed ETT Pediatric patients intubated with a cuffed endotracheal tube for adenotonsillectomy.	Device: Cuffed ETT; Other Names: Kimberly Clark Microcuff ETT

Outcome Measures

Primary Outcome Measures

1. Changes in the Intracuff Pressure [during time of surgery]

   Changes in the intracuff pressure from baseline of cuffed ETT's after positioning of the patient's head and retractor placement.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Less than 18 years of age, undergoing otolaryngological surgery with endotracheal intubation.

Exclusion Criteria:

• Patient who is intubated with an uncuffed endotracheal tube.

• Patients who have a limitation for movement of the neck or concerns of the stability of the cervical spine.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nationwide Children's Hospital	Columbus	Ohio	United States	43205

Sponsors and Collaborators

• Kris Jatana

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kris Jatana, ENT Surgeon, Nationwide Children's Hospital
• ClinicalTrials.gov Identifier: NCT02376179
• Other Study ID Numbers: IRB13-00613
• First Posted: Mar 3, 2015
• Last Update Posted: Dec 11, 2019
• Last Verified: Dec 1, 2019

Study Results

Participant Flow

Arm/Group Title	Cuffed ETT
Arm/Group Description	Pediatric patients intubated with a cuffed endotracheal tube for adenotonsillectomy.
Period Title: Overall Study
STARTED	84
COMPLETED	84
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Cuffed ETT
Arm/Group Description	Pediatric patients intubated with a cuffed endotracheal tube for adenotonsillectomy. Cuffed ETT
Overall Participants	84
Age (Count of Participants)
<=18 years	84 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	5.7 (3.9)
Sex: Female, Male (Count of Participants)
Female	46 54.8%
Male	38 45.2%
Region of Enrollment (participants) [Number]
United States	84 100%

Outcome Measures

1. Primary Outcome

Title	Changes in the Intracuff Pressure
Description	Changes in the intracuff pressure from baseline of cuffed ETT's after positioning of the patient's head and retractor placement.
Time Frame	during time of surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cuffed ETT
Arm/Group Description	Pediatric patients intubated with a cuffed endotracheal tube for adenotonsillectomy. Cuffed ETT
Measure Participants	84
Mean (Standard Deviation) [cmH2O]	3 (7)

Adverse Events

Arm/Group Title	Cuffed ETT
Arm/Group Description	Pediatric patients intubated with a cuffed endotracheal tube for adenotonsillectomy.
All Cause Mortality
	Cuffed ETT
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Cuffed ETT
	Affected / at Risk (%)	# Events
Total	0/84 (0%)
Other (Not Including Serious) Adverse Events
	Cuffed ETT
	Affected / at Risk (%)	# Events
Total	0/84 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT 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.