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

Ventilator Associated Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03267693
• Other study ID #: Gastrointestinal tract and VAP
• Status: Not yet recruiting
• Phase: N/A
• First received: August 27, 2017
• Last updated: August 29, 2017
• Start date: September 2017
• Est. completion date: October 2018

Study information

• Verified date: August 2017
• Source: Assiut University
• Contact: Menna Allah Gamal Said, BSC
• Phone: 01028153777
• Email: menna1992[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 2018
• Est. primary completion date: September 2018
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Respiratory Tract Infections
• Ventilator Associated Pneumonia

Intervention

Diagnostic Test:
• Gastric and oropharyngeal PH
measurement of gastric and oropharyngeal PH and their relation to respiratory and gastrointestinal complication in mechanically ventilated patients

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (1)

Hunter JD. Ventilator associated pneumonia. Postgrad Med J. 2006 Mar;82(965):172-8. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measurement of gastric and oropharyngeal ph in mechanically ventilated patients	correlation between gastric and oropharyngeal ph and presence of gastrointestinal and respiratory complications in mechanically ventilated patients	30 minutes