Gastrointestinal Complications in Association With Oropharyngeal and Respiratory Infections in Mechanical Ventilation

August 29, 2017 updated by: Menna Allah Gamal, Assiut University
Detection of gastrointestinal complications in mechanically ventilated critically ill patients and its relation to oropharyngeal and respiratory infections in relation to oropharyngeal and gastric PH.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Detailed Description

Hospital acquired or nosocomial infections continue to be an important cause of morbidity and mortality. The critically ill patient is at particular risk of developing intensive care unit acquired infection, with the lungs being especially vulnerable. Nosocomial bacterial pneumonia occurring after two days of mechanical ventilation is referred to as ventilator associated pneumonia, and is the most common nosocomial infection seen in the intensive care unit. Intubation of the trachea and mechanical ventilation is associated with a 7-fold to 21-fold increase in the incidence of pneumonia and up to 28% of patients receiving mechanical ventilation will develop this complication. Its development is associated with an attributable increase in morbidity and mortality. Ventilator associated pneumonia (VAP) is defined as nosocomial pneumonia occurring in a patient after 48 hours of mechanical ventilation via a tracheal or tracheostomy tube. It is commonly classified as either early onset (occurring within 96 hours of start of mechanical ventilation) or late onset (.96 hours after start of mechanical ventilation). It is a common condition, difficult to diagnose accurately, and expensive to treat. Its development prolongs a patient's stay in the intensive care unit (ICU), and is associated with significant morbidity and mortality. Most cases seem to result from aspiration of pathogenic material that commonly colonises the oropharyngeal airways of the critically ill. Simple measures to decrease the incidence of aspiration or reduce the burden of colonisation of the oropharynx may aid in the prevention of ventilator associated pneumonia. VAP is the infection that occurs 48 hours after intubation, which was not incubated during the period of the patient's admission, and 72 hours after extubation.

The gastrointestinal tract is believed to play an important role in ventilator-associated pneumonia (VAP), because during critical illness the stomach often is colonized with enteric Gram-negative bacteria. These are the same bacteria that frequently are isolated from the sputum of patients with VAP.

This is known as the "gastropulmonary hypothesis" and it postulates the following sequence. First, the stomach is colonized by potentially pathogenic microorganisms, either from an exogenous source (contaminated liquid injected into a nasogastric tube), or from an endogenous source (Detection of gastrointestinal complications in mechanically ventilated critically ill patients and its relation to oropharyngeal and respiratory infections in relation to oropharyngeal and gastric PH duodenogastric reflux). This is followed by retrograde colonization of the oropharynx . Finally, the lower respiratory tract is colonized from sustained microaspiration of contaminated oropharyngeal (or gastric) secretions around the endotracheal tube cuff.

The Role of Gastric pH on the Incidence of VAP

Under fasting conditions, gastric sterility is maintained by an acidic pH. Clinical evidence suggests that a gastric pH of 3.5 prevents bacterial colonization, whereas a pH 4.0 is associated with clinically important bacterial colonization and a higher incidence of nosocomial pneumonia.

Critically-ill patients with either respiratory failure requiring mechanical ventilation or coagulopathy are at increased risk for clinically important, stress-related GI bleeding .This has been associated with a significantly higher mortality rate, compared to patients without evidence of bleeding (48.5 vs 9.1%, p _ 0.001).

Giving that such patients show an increasing risk of important gastrointestinal (GI) bleeding, stress-ulcer prophylaxis (SUP) has been recommended for the prevention of upper GI hemorrhage. SUP strategy rely on drugs that block the secretion of gastric acid and increase the gastric pH (histamine-2-receptor antagonists - H2RA, and proton pump inhibitor - PPI) and those that does not alter gastric pH (sucralfate). The increase of gastric pH leads to bacterial overgrowth and potential colonization of trachea determining a higher risk of VAP.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

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Study Contact

Study Contact

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Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

male and female patients between 18 and 70 years in ICU units on mechanical ventilator

Description

Inclusion Criteria:

  • all critically ill mechanically ventilated patients between 18 and 70 years

Exclusion Criteria:

  • patients take drugs affect gastric and oropharyngeal PH such as antacids, proton pump inhibitors, H2 receptor antagonists

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
measurement of gastric and oropharyngeal ph in mechanically ventilated patients
Time Frame: 30 minutes
correlation between gastric and oropharyngeal ph and presence of gastrointestinal and respiratory complications in mechanically ventilated patients
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2018

Study Registration Dates

First Submitted

First Submitted

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August 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 30, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 30, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Gastrointestinal tract and VAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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