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

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

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.

Study Overview

• Status: Unknown
• Conditions: Atelectasis
• Intervention / Treatment: Other: Inspiratory hold

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.

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah LB Wilberg, Bachelor; Phone Number: +47 95 80 82 90; Email: sara-wi@online.no
• Study Contact Backup: Name: Knut Gaustad, MD; Phone Number: +47 41 55 25 76; Email: knut.gaustad@getmail.no

Study Locations

• Norway
  • Oslo, Norway, 0450
    • Recruiting
    • Oslo University Hospital, Ullevål
    • Contact: Sarah LB Wilberg, Bachelor; Phone Number: +4795808290; Email: sara-wi@online.no
    • Contact: Knut Gaustad, MD; Phone Number: +4741552576; Email: knut.gaustad@getmail.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Inspiratory hold; Mechanical inspiratory pressure held for 10 seconds at a time.	Other: Inspiratory hold; Sustainment of the ventilators inspiratory pressure for 10 seconds at a time

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: University of Oslo
• Investigators: Principal Investigator: Nina K Vøllestad, Dr.Scient, University of Oslo; Study Chair: Harald Noddeland, PhD, MD, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Anticipated): April 1, 2015
• Study Completion (Anticipated): August 1, 2015

Study Registration Dates

• First Submitted: November 5, 2014
• First Submitted That Met QC Criteria: November 6, 2014
• First Posted (Estimate): November 7, 2014

Study Record Updates

• Last Update Posted (Estimate): November 24, 2014
• Last Update Submitted That Met QC Criteria: November 21, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis
• Other Study ID Numbers: 2014/375 (REK)