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

NCT ID: NCT02285894

Last Updated: 2014-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-08-31

Brief Summary

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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

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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.

Conditions

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Atelectasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Inspiratory hold

Mechanical inspiratory pressure held for 10 seconds at a time.

Group Type EXPERIMENTAL

Inspiratory hold

Intervention Type OTHER

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

Interventions

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Inspiratory hold

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oslo

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nina K Vøllestad, Dr.Scient

Role: PRINCIPAL_INVESTIGATOR

University of Oslo

Harald Noddeland, PhD, MD

Role: STUDY_CHAIR

Oslo University Hospital

Locations

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Oslo university Hospital, Ullevål

Oslo, Oslo County, Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Sarah LB Wilberg, Bachelor

Role: CONTACT

+47 95 80 82 90

Knut Gaustad, MD

Role: CONTACT

+47 41 55 25 76

Facility Contacts

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Sarah LB Wilberg, Bachelor

Role: primary

+4795808290

Knut Gaustad, MD

Role: backup

+4741552576

Other Identifiers

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2014/375 (REK)

Identifier Type: -

Identifier Source: org_study_id