Oropharyngeal and Nasopharyngeal Decontamination With Chlorhexidine Gluconate in the Reduction of the Postoperative Morbidity and Mortality After Major Pulmonary Resections

Study Overview
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Brief Summary
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Despite improvement of per and postoperative management, major pulmonary surgery continues to carry out a high morbidity with a significant mortality. Among postoperative complications, respiratory failures (nosocomial pneumonia, ARDS) are currently the most frequent and serious, as well as being the primary cause of hospital death, after major pulmonary resections. Vast majority of these complications are notoriously infectious and should be considered as hospital-acquired infections. These complications result in a dramatic increased of substantial hospital costs in term of length of hospital stay, antibiotics and morbidity. Current management of these complications stands on antibiotics, oxygen supply and physiotherapy. In severe case, a ventilatory support (invasive or non invasive) is justify in near 25 % of cases. Recent data have suggested that proximal airways colonizations could be an essential first step in the pathogenesis of theses respiratory failures. Previous works have long demonstrated that bacterial colonization was frequent between 21 to 40 % in lung cancer patients. These colonizations could act as a major predisposing factor to these postoperative respiratory failures. Because distal airways and lung parenchyma are free from bacteria at the moment of the surgery, respiratory complications should be the result from contamination by potential microorganisms belonging the upper aero-digestive tract. Consequently, decontamination of the oropharyngeal and nasopharyngeal cavities before and during the first days after surgery could have a beneficial advantage in the prevention of these complications. This decontamination has been demonstrated to be effective in critically-ill patients in intensive care unit, in cardiac surgery and in esophageal surgery. Decontamination of oropharynx and nasopharynx with Chlorhexidine Gluconate has significantly reduced the rate of postoperative global hospital-acquired infections and respiratory infectious as well. To date, data on the efficacy of this decontamination protocol in major pulmonary resections are not available.

Official Title
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Oropharyngeal and Nasopharyngeal Decontamination With Chlorhexidine Gluconate in the Reduction of the Postoperative Morbidity and Mortality After Major Pulmonary Resections: a Multicentric, Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial

Conditions
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Infections and Respiratory Infectious

Intervention / Treatment
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* Drug: Chlorhexidine Gluconate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult men and women over 18 years Submitted to major pulmonary resections for primary lung cancer or pulmonary metastasis Anatomical resections (segmentectomy, lobectomy, pneumonectomy) With mediastinal lymph node dissection. Patient fit for operation After informed consent Non inclusion criteria: Patients < 18 years Pulmonary infectious lesions Recent respiratory infections Tracheostomy Swallow difficulties Need for non-invasive ventilation before surgery Documented sensibility to Chlorhexidine Previous ENT cancer Previous thoracic surgery Patients with an oral assessment score (OAG) >9

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: chlorhexidine gluconate<br> | Drug: Chlorhexidine Gluconate<br>* Oropharyngeal and nasopharyngeal decontamination with Chlorhexidine Gluconate<br>|
| Experimental: placebo<br> | Drug: Placebo<br>* Oropharyngeal and nasopharyngeal decontamination with placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of patients requiring ventilatory support |  | 36 MONTHS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of documented hospital-acquired respiratory infections |  | 36 MONTHS | 
| occurrence of documented non-respiratory hospital-acquired infections |  | 36 months |