Can 10 Seconds Inspiratory Hold Open Atelectasis in Mechanically Ventilated Patients?
1 other identifier
interventional
12
1 country
1
Brief Summary
This study evaluates whether sustaining inspiratory pressure for 10 seconds at a time can open collapsed lung areas in non-dependant regions of the lung in mechanically ventilated patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 5, 2014
CompletedFirst Posted
Study publicly available on registry
November 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedNovember 24, 2014
November 1, 2014
5 months
November 5, 2014
November 21, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Ventilation in previously non-ventilated lung tissue
Registered using electrical impedance tomography, E.I.T., via PulmoVista500 by Dräger Medical
During intervention and for 30 minutes after ended intervention
Study Arms (1)
Inspiratory hold
EXPERIMENTALMechanical inspiratory pressure held for 10 seconds at a time.
Interventions
Sustainment of the ventilators inspiratory pressure for 10 seconds at a time
Eligibility Criteria
You may qualify if:
- Continuously or intermittently mechanically ventilated with artificial airway (endotracheal tube or tracheostomy tube)
- Pressure controlled or pressure supported ventilator mode
- PEEP ≤ 12 cm H2O, registered peak pressure ≤ 32 cm H2O
- Non-ventilated lung regions according to E.I.T. measurements
- Richmond Agitation Score 0 -(-5)
- Circulatory stable or stabilized
You may not qualify if:
- Pregnancy
- BMI \> 50
- Pacemaker or other electrically active implants
- Skin lesions, wounds or bandages on chest area where E.I.T. belt needs to be placed
- Undrained pneumothorax
- Pulsating air-mattress
- Unstable skeletal injury to spinal column
- Recent brain injury or spinal chord injury
- Recent injury to heart, to major blood vessels in chest, to major airways or to the oesophagus.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oslo University Hospitallead
- University of Oslocollaborator
Study Sites (1)
Oslo university Hospital, Ullevål
Oslo, Oslo County, 0450, Norway
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nina K Vøllestad, Dr.Scient
University of Oslo
- STUDY CHAIR
Harald Noddeland, PhD, MD
Oslo University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2014
First Posted
November 7, 2014
Study Start
November 1, 2014
Primary Completion
April 1, 2015
Study Completion
August 1, 2015
Last Updated
November 24, 2014
Record last verified: 2014-11