An interventional study of Preoperative oral decontamination with chlorhexidine in Bacterial Transmission, Intubation Intratracheal and Chlorhexidine, sponsored by University Hospital Ulm. Not yet recruiting at 1 site in Germany. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by University Hospital Ulm · Not applicable, Interventional, and Prevention
Postoperative respiratory complications, such as bacterial pneumonia, are common and serious problems after general anesthesia. They can lead to longer hospital stays, more complications, and increased mortality. One possible cause is that bacteria from the mouth and throat enter the lower airways during tracheal intubation.
The mouth and throat naturally contain many bacteria, including potentially harmful microorganisms. During general anesthesia, coughing and swallowing reflexes are reduced or absent. When a tracheal tube is inserted, secretions from the mouth and throat may be carried into the trachea. The tube may also support the movement of contaminated fluid into the lower airways.
ORAL-PROTECT I is a prospective, randomized, controlled study. It investigates whether simple oral hygiene before surgery can reduce the transfer of bacteria into the trachea during airway management under general anesthesia.
The study includes patients aged 60 years or older undergoing elective surgery under general anesthesia with tracheal intubation. Participants are randomly assigned to an intervention group or a control group. The intervention group performs oral hygiene immediately before anesthesia. This includes brushing the teeth and tongue for about 3 minutes, followed by rinsing and gargling for about 1 minute with a chlorhexidine antiseptic solution. The control group receives standard care without additional oral hygiene.
Oral, pharyngeal, and tracheal swabs will be collected at predefined time points. The primary outcome is based on the perioperative tracheal bacterial load, sampled every 30 minutes and assessed at two hours after induction of anesthesia. The co-primary outcome is based on the oral bacterial load immediately before endotracheal intubation.
Secondary outcomes include changes in oral and tracheal bacterial load over time and identification of the microorganisms detected. The study aims to clarify early bacterial transfer during airway management and to evaluate whether a simple preoperative oral hygiene measure can reduce this process.
ORAL-PROTECT I is a prospective, randomized, controlled, unblinded, parallel-group trial investigating whether preoperative oral hygiene can reduce early bacterial transmission from the mouth and throat into the trachea during airway management under general anesthesia.
Postoperative respiratory complications, including bacterial pneumonia, are common and clinically relevant adverse events after general anesthesia. They can contribute to increased morbidity, prolonged hospital stay, and mortality. One possible mechanism is the transmission of bacteria from the oral cavity and pharynx into the lower airways during tracheal intubation. The oral cavity and pharynx naturally contain a broad bacterial flora, including potentially pathogenic microorganisms. During general anesthesia, protective swallowing and coughing reflexes are reduced or absent. During tracheal intubation, bacteria-contaminated secretions from the mouth and throat may enter the trachea and lower airways.
The study includes patients aged 60 years or older undergoing elective surgery under general anesthesia with tracheal intubation. Potentially eligible patients are screened before surgery. Patients are screened for eligibility during pre-admission testing and are approached for study participation. On the day of surgery, patients are reassessed for eligibility before randomization to confirm that eligibility criteria are still met. Patients who performed oral hygiene less than four hours before induction are excluded before randomization.
Eligible participants are randomly assigned to either the intervention group or the control group using a REDCap-based randomization tool. Participants in the intervention group undergo supervised oral hygiene immediately before induction of anesthesia, consisting of 3 minutes of tongue and tooth brushing and 1 minute of chlorhexidine gargling. Participants in the control group receive standard clinical care without additional preoperative oral hygiene measures. All other perioperative procedures, including anesthetic management, airway management, surgical care, and postoperative treatment, are at the discretion of the treating anesthesiologist and independent of study participation.
Bacterial load is assessed using swab-based microbiological sampling at predefined time points. Samples are collected from the oral cavity, pharynx, and trachea to describe perioperative bacterial contamination and its development over time. The perioperative tracheal bacterial load is sampled at 30-minute intervals.
Sample handling and microbiological processing follow a standardized operating procedure. This includes uniform transport conditions, timely laboratory processing, neutralization of residual antiseptic activity, serial dilution, plating on appropriate culture media, aerobic incubation, and quantitative colony counting. Samples from both study groups are processed identically to minimize systematic bias and allow reliable comparison of bacterial load. Additional assessments include the intraoperative course of tracheal bacterial load, tracheal bacterial load before extubation, oral bacterial load approximately 24 hours after surgery, and qualitative microbiological characterization of detected bacteria. Adverse events are evaluated after the intervention and anesthesia.
The study aims to provide insight into early perioperative bacterial transmission during airway management and to evaluate whether a simple, low-risk preoperative oral hygiene intervention can influence bacterial contamination of the trachea under general anesthesia.
University Hospital Ulm is the lead sponsor of 10 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard clinical care without additional preoperative oral hygiene or oral decontamination measures before induction of general anesthesia.
Supervised preoperative oral decontamination immediately before induction of general anesthesia using chlorhexidine for 1 minute \& tooth/tongue brushing for 3 minutes
Procedure: Preoperative oral decontamination with chlorhexidine
The intervention consists of supervised preoperative oral decontamination performed in the operating room holding/ induction area immediately before induction of general anesthesia. Participants brush their teeth and tongue for 3 minutes, followed by a rinse with chlorhexidine oral antiseptic solution for 1 minute. The intervention is performed right before endotracheal intubation. All other perioperative procedures are at the discretion of the anesthesiologist in the room.
Change in tracheal bacterial load at 2 hours after anesthesia induction
The primary outcome is the change in tracheal bacterial load, defined through tracheal swab obtained 2 hours after induction of anesthesia.
Time frame: At 2 hours after induction and intubation
Change in oral bacterial load
The co-primary outcome is the peri-interventional change in oral bacterial load due to the oral hygiene measures obtained through oral swabs immediately before endotracheal intubation.
Time frame: Immediately before endotracheal intubation.
Intraoperative development of tracheal bacterial load
This secondary outcome assesses the intraoperative development of tracheal bacterial load during the surgery. Serial tracheal samples are collected every 30 minutes until extubation.
Time frame: Every 30 minutes intraoperatively from endotracheal intubation until washout of anesthesia prior to extubation.
Change of tracheal bacterial load immediately before extubation
This secondary outcome assesses the tracheal bacterial load immediately before extubation.
Time frame: Immediately before extubation.
Change of oral bacterial load 24 hours postoperatively
This secondary outcome assesses the change in oral bacterial load obtained 24 (± 2) hours after surgery.
Time frame: Approximately 24 hours postoperatively, with a tolerance of ±2 hours.
Qualitative microbiological characterization of bacteria detected in tracheal samples
Descriptive analysis of colony forming bacteria that were obtained through tracheal swabs.
Time frame: Tracheal swabs are obtained from right after intubation until extubation. For the primary outcome all samples are plated. If Colony Forming Units (CFU) occur on those within 48 hours, characterization will be performed.
Safety events related to the oral hygiene intervention
This secondary outcome assesses safety events potentially related to the preoperative oral hygiene intervention, including oral mucosal irritation, discomfort, intolerance of the mouth rinse, or other adverse events.
Time frame: From the start of the oral hygiene intervention until approximately 24 hours postoperatively.
Plan to share: No
Start is estimated for Jun 2026; primary completion for Oct 2026, 4 months later.
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