Protective Manual Hyperinflation in Acute Mechanically Ventilated Trauma Patients

NCT ID: NCT01366274

Last Updated: 2011-06-06

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2011-12-31

Brief Summary

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This single-blinded randomized study aims to compare two methods of manual hyperinflation (protective - moderate tidal volumes with positive end expiratory pressure) and non-protective (large tidal volume and no positive end expiratory pressure) in ventilated acute trauma patients, to investigate the effect on inflammatory markers, lung compliance, oxygenation and sputum volume.

Detailed Description

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Current evidence in mechanical ventilation supports a "protective lung strategy" that is, smaller tidal volumes and prevention of loss of positive end expiratory pressure (PEEP). There is concern that manual hyperinflation (MHI) may conflict with this strategy and cause volutrauma and atelectrauma potentially leading to biotrauma.

This single-blinded randomized study aims to compare two methods of manual hyperinflation (protective - moderate tidal volumes with positive end expiratory pressure) and non-protective (large tidal volume and no positive end expiratory pressure) in ventilated acute trauma patients, to investigate the effect on inflammatory markers, lung compliance, oxygenation and sputum volume.

Conditions

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Critically Injured Mechanically Ventilated Trauma Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Usual method of MHI

Group Type ACTIVE_COMPARATOR

Usual method of MHI

Intervention Type OTHER

Manual hyperinflation for 10 minutes using a Mapleson C circuit and 100% oxygen with volume set at 12mls/kg and no positive end expiratory pressure in the circuit

Protective MHI

Group Type EXPERIMENTAL

Protective manual hyperinflation

Intervention Type OTHER

Manual hyperinflation for 10 minutes using a Mapleson C circuit and 100% oxygen with volume set at 8mls/kg and positive end expiratory pressure in the circuit appropriate to baseline levels

Interventions

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Protective manual hyperinflation

Manual hyperinflation for 10 minutes using a Mapleson C circuit and 100% oxygen with volume set at 8mls/kg and positive end expiratory pressure in the circuit appropriate to baseline levels

Intervention Type OTHER

Usual method of MHI

Manual hyperinflation for 10 minutes using a Mapleson C circuit and 100% oxygen with volume set at 12mls/kg and no positive end expiratory pressure in the circuit

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Trauma patients
* Day 1 of admission to intensive care
* Mechanically ventilated

Exclusion Criteria

* Pre-existing lung disease
* PEEP \> 12.5cmH20
* Nitric oxide in circuit
* Haemodynamically unstable
* Undrained pneumothorax
* Intracranial pressure \> 25mmHg
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royal Brisbane and Women's Hospital

OTHER_GOV

Sponsor Role collaborator

The University of Queensland

OTHER

Sponsor Role lead

Responsible Party

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University of Queensland

Locations

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Royal Brisbane & Womens Hospital

Brisbane, Queensland, Australia

Site Status

Countries

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Australia

Other Identifiers

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PMH1

Identifier Type: -

Identifier Source: org_study_id

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