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Completed

NCT Number: NCT02284178

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

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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Key information

Conditions

Respiratory Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orlando Regional Medical Center

Orlando, Florida, 32806, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enhanced oropharyngeal suction

Other

Deep oropharyngeal suction with catheter every 4 hours

Usual Care

Other

Oral suction with suction swab every 4 hours

Primary outcomes

  1. Microaspiration as Measured by Tracheal Amylase

    Time frame: Every 12 hours up to 14 days

    Specimens will be obtained every 12 hours for up to 14 days or subject no longer meets inclusion (e.g., extubation, tracheostomy, etc.); tracheal amylase measured in U/L.

  2. Microaspiration as Measured by Percentage of Tracheal Specimens Positive for Amylase Per Participant

    Time frame: Every 12 hours up to 14 days

    Specimens will be obtained every 12 hours for up to 14 days or subject no longer meets inclusion criteria

Secondary outcomes

  1. Ventilator-Associated Condition (VAC) Rate

    Time frame: VAC assessed for 2 days beyond last intervention; mean 5.4 days

    VAC rate was calculated between control and intervention groups using the Centers for Disease Control and Prevention (2013) criteria.

  2. Time to VAC

    Time frame: VAC was assessed for two days beyond the last intervention; mean 5.4 days

Other outcomes

  1. Tracheal to Oral Ratio of Amylase

    Time frame: Every 12 hours up to 14 days

    The ratio of the tracheal value to the oral value of amylase for each paired sample was calculated (ratio included baseline specimen collected).

Sponsors and collaborators

Lead sponsor

University of Central Florida

Other

Collaborators

  • Orlando Regional Medical Center

Registry information

Acronym: NO-ASPIRATE

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Nov 5, 2014
Registry last updated
Aug 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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