Can 10 Seconds Inspiratory Hold Open Atelectasis in Mechanically Ventilated Patients?

Atelectasis Clinical Trial

Official title:

Can 10 Seconds Inspiratory Hold Open Atelectasis in Mechanically Ventilated Patients? A Pilot Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02285894
• Other study ID #: 2014/375 (REK)
• Status: Recruiting
• Phase: N/A
• First received: November 5, 2014
• Last updated: November 21, 2014
• Start date: November 2014
• Est. completion date: August 2015

Study information

• Verified date: November 2014
• Source: Oslo University Hospital
• Contact: Sarah LB Wilberg, Bachelor
• Phone: +47 95 80 82 90
• Email: sara-wi[@]online.no
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Interventional

Clinical Trial 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.

Description:

Collapse of lung volume, atelectasis, is a common complication in sedated and mechanically ventilated patients. In adults the atelectasis occur mainly in the dependant areas of the lung. In this study the investigators examine whether these atelectasis can be opened by repeatedly sustaining the inspiratory pressure for 10 seconds when the patient has been positioned so that the atelectasis is located in a non-dependant position. Furthermore, the investigators examine how many times the inspiratory pressure needs to be sustained before the atelectasis is opened and at what pressure.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: August 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atelectasis
• Pulmonary Atelectasis

Intervention

Other:
• Inspiratory hold
Sustainment of the ventilators inspiratory pressure for 10 seconds at a time

Locations

Country	Name	City	State
Norway	Oslo university Hospital, Ullevål	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No