Oral Suction Intervention to Reduce Aspiration and Ventilator Events: NO-ASPIRATE

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

513 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2017-12-31

Brief Summary

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Insertion of a breathing tube to enable treatment with mechanical ventilation (respirator) is often associated with complications, such as infection and lung injury. Leakage of secretions around the breathing tube (microaspiration) is a major factor leading to complications. The investigators propose that a standardized, enhanced oral suction protocol will be effective in reducing microaspiration and harms associated with mechanical ventilation. The investigators hypothesize that those randomized to the enhanced oral suction protocol will have less microaspiration and other ventilator-associated conditions than those in the usual care, standard suction group.

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Detailed Description

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Conditions

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Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Enhanced oral suction

Deep oropharyngeal suction with catheter

Group Type EXPERIMENTAL

Enhanced oropharyngeal suction

Intervention Type OTHER

Deep oropharyngeal suction with catheter every 4 hours

Usual Care Oral Suction

Oropharyngeal suction with suction swab

Group Type SHAM_COMPARATOR

Usual Care

Intervention Type OTHER

Oral suction with suction swab every 4 hours

Interventions

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Enhanced oropharyngeal suction

Deep oropharyngeal suction with catheter every 4 hours

Intervention Type OTHER

Usual Care

Oral suction with suction swab every 4 hours

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* orally intubated with endotracheal tube and treated with mechanical ventilation
* 24 hours or less since intubation
* expected to be intubated for at least 36 hours after enrollment

Exclusion Criteria

* documented aspiration at time of intubation
* intubation to treat known aspiration
* treatment with rescue mechanical ventilation therapies (oscillator)
* re-intubation
* contraindications to receiving the intervention (e.g., oral injuries)
* history of lung or head/neck cancers that may produce amylase in the lungs
* history of disease that affects saliva production (e.g., Sjögren's syndrome)
* prisoners

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No