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Trial Outcomes & Findings for Effects of Sternal Wall Pressure in Children (NCT NCT00628407)

NCT ID: NCT00628407

Last Updated: 2011-03-11

Results Overview

The mean sternal force (measured in kg as a surrogate for Newtons \[1kg = 9.81 newtons\]) associated with a ≥2cm H2O peak endotracheal pressure (ETP) change.

Recruitment status

COMPLETED

Target enrollment

13 participants

Primary outcome timeframe

per case

Results posted on

2011-03-11

Participant Flow

Potential subjects were screened from January 1, 2007-June 2, 2008 using the protocol inclusion and exclusion criteria. Any patient in the PICU (7 South or 7 East), Progressive Care Unit (PCU) and Operating Room (OR) settings involving stable but critically ill, mechanically ventilated children from 6 months to \< 8 years of age.

Participant milestones

Participant milestones
Measure
Sternal Wall Pressure
Subjects that received gentle incremental sternal wall pressure.
Overall Study
STARTED
13
Overall Study
COMPLETED
13
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Sternal Wall Pressure in Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Sternal Wall Pressure
n=13 Participants
Age, Categorical
<=18 years
13 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Age Continuous
2.2 years
STANDARD_DEVIATION 2 • n=5 Participants
Sex: Female, Male
Female
1 Participants
n=5 Participants
Sex: Female, Male
Male
12 Participants
n=5 Participants
Region of Enrollment
United States
13 participants
n=5 Participants

PRIMARY outcome

Timeframe: per case

The mean sternal force (measured in kg as a surrogate for Newtons \[1kg = 9.81 newtons\]) associated with a ≥2cm H2O peak endotracheal pressure (ETP) change.

Outcome measures

Outcome measures
Measure
Sternal Wall Pressure
n=13 Participants
Sternal Force Associated With Change in Intrathoracic Pressure.
2.8 kg
Standard Deviation 0.9

Adverse Events

Sternal Wall Pressure

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vinay Nadkarni, MD

Children's Hospital of Philadelphia

Phone: 215-590-7430

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place