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

Primary Purpose

Atelectasis

Status

Unknown status

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

Inspiratory hold

Sponsored by

Oslo University Hospital

About this trial

This is an interventional treatment trial for Atelectasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Oslo university Hospital, UllevålRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Inspiratory hold

Arm Description

Mechanical inspiratory pressure held for 10 seconds at a time.

Outcomes

Primary Outcome Measures

Ventilation in previously non-ventilated lung tissue

Registered using electrical impedance tomography, E.I.T., via PulmoVista500 by Dräger Medical

Secondary Outcome Measures

Full Information

NCT ID

First Posted

November 5, 2014

Last Updated

November 21, 2014

Sponsor

Oslo University Hospital

Collaborators

University of Oslo

1. Study Identification

Unique Protocol Identification Number

NCT02285894

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Unknown status

Study Start Date

November 2014 (undefined)

Primary Completion Date

April 2015 (Anticipated)

Study Completion Date

August 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Oslo University Hospital

Collaborators

University of Oslo

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atelectasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Inspiratory hold

Arm Type

Experimental

Arm Description

Mechanical inspiratory pressure held for 10 seconds at a time.

Intervention Type

Other

Intervention Name(s)

Inspiratory hold

Intervention Description

Sustainment of the ventilators inspiratory pressure for 10 seconds at a time

Primary Outcome Measure Information:

Title

Ventilation in previously non-ventilated lung tissue

Description

Registered using electrical impedance tomography, E.I.T., via PulmoVista500 by Dräger Medical

Time Frame

During intervention and for 30 minutes after ended intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sarah LB Wilberg, Bachelor

Phone

+47 95 80 82 90

Email

sara-wi@online.no

First Name & Middle Initial & Last Name or Official Title & Degree

Knut Gaustad, MD

Phone

+47 41 55 25 76

Email

knut.gaustad@getmail.no

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nina K Vøllestad, Dr.Scient

Organizational Affiliation

University of Oslo

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Harald Noddeland, PhD, MD

Organizational Affiliation

Oslo University Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Oslo university Hospital, Ullevål

City

Oslo

ZIP/Postal Code

0450

Country

Norway

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sarah LB Wilberg, Bachelor

Phone

+4795808290

Email

sara-wi@online.no

First Name & Middle Initial & Last Name & Degree

Knut Gaustad, MD

Phone

+4741552576

Email

knut.gaustad@getmail.no

12. IPD Sharing Statement

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

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