ORAL-PROTECT I: Oral Asepsis Preventing Transmission During Intubation (ORAL-PROTECT I)

June 21, 2026 updated by: Manfred Blobner, University Hospital Ulm

ORAL-PROTECT I: Oral Asepsis for Preoperative Reduction Of Tracheal Bacterial Establishment, Colonization, and Transmission

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Physician on Duty
  • Phone Number: +49-731-50060043

Study Locations

  • Germany
    • Baden-Wurttemberg
      • Ulm, Baden-Wurttemberg, Germany, 89081
        • Ulm University Medical Center, Department of Anesthesiology and Intensive Care Medicine
        • Contact:

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 60 years
  • Elective surgery under general anesthesia with endotracheal intubation
  • Expected duration of surgery ≥ 2 hours
  • Ability to provide written informed consent

Exclusion Criteria:

  • Systemic antibiotic therapy within 7 days before surgery
  • Planned postoperative systemic antibiotic therapy
  • Known hypersensitivity or allergy to chlorhexidine
  • Pneumonia or clinically relevant respiratory infection within 7 days before surgery
  • Inability to perform the study intervention as intended
  • Preoperative oral hygiene on the day of surgery, less than four hours prior to induction of the general anesthesia

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of care
Standard clinical care without additional preoperative oral hygiene or oral decontamination measures before induction of general anesthesia.
Active Comparator: Preoperative oral decontamination with chlorhexidine & tooth & tongue brushing
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in tracheal bacterial load at 2 hours after anesthesia induction
Time Frame: At 2 hours after induction and intubation
The primary outcome is the change in tracheal bacterial load, defined through tracheal swab obtained 2 hours after induction of anesthesia.
At 2 hours after induction and intubation
Change in oral bacterial load
Time Frame: Immediately before endotracheal intubation.
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.
Immediately before endotracheal intubation.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative development of tracheal bacterial load
Time Frame: Every 30 minutes intraoperatively from endotracheal intubation until washout of anesthesia prior to extubation.
This secondary outcome assesses the intraoperative development of tracheal bacterial load during the surgery. Serial tracheal samples are collected every 30 minutes until extubation.
Every 30 minutes intraoperatively from endotracheal intubation until washout of anesthesia prior to extubation.
Change of tracheal bacterial load immediately before extubation
Time Frame: Immediately before extubation.
This secondary outcome assesses the tracheal bacterial load immediately before extubation.
Immediately before extubation.
Change of oral bacterial load 24 hours postoperatively
Time Frame: Approximately 24 hours postoperatively, with a tolerance of ±2 hours.
This secondary outcome assesses the change in oral bacterial load obtained 24 (± 2) hours after surgery.
Approximately 24 hours postoperatively, with a tolerance of ±2 hours.
Qualitative microbiological characterization of bacteria detected in tracheal samples
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.
Descriptive analysis of colony forming bacteria that were obtained through tracheal swabs.
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
Time Frame: From the start of the oral hygiene intervention until approximately 24 hours postoperatively.
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.
From the start of the oral hygiene intervention until approximately 24 hours postoperatively.

Collaborators and Investigators

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

Sponsor

University Hospital Ulm

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 20, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

May 27, 2026

First Submitted That Met QC Criteria

June 21, 2026

First Posted (Actual)

June 25, 2026

Study Record Updates

Last Update Posted (Actual)

June 25, 2026

Last Update Submitted That Met QC Criteria

June 21, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ethical Committee Number 23/26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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