ORAL-PROTECT I: Oral Asepsis Preventing Transmission During Intubation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversity Hospital Ulm
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 60 years
Elective surgery under general anesthesia with endotracheal intubation
Expected duration of surgery ≥ 2 hours
Ability to provide written informed consent
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Preoperative oral decontamination with chlorhexidine
Procedure/SurgeryThe 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Standard of careNo intervention 0 interventions
Group B: Preoperative oral decontamination with chlorhexidine & tooth & tongue brushingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 intubation2
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.Secondary outcomes
1
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.2
Change of tracheal bacterial load immediately before extubation
This secondary outcome assesses the tracheal bacterial load immediately before extubation.
Time frame
Immediately before extubation.3
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.4
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: