ORAL-PROTECT I: Oral Asepsis Preventing Transmission During Intubation

NCT07669064 | Not Yet Recruiting

• 1 other identifier: Ethical Committee Number 23/26
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bacterial Transmission; Intubation Intratracheal; Chlorhexidine

Keywords

anesthesia, general; oral hygiene; bacterial load; oropharyngeal; respiratory mucosa; chlorhexidine; tracheal intubation; mouth rinsing

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Immediately before endotracheal intubation.

Secondary Outcomes (5)

• Intraoperative development of tracheal bacterial load

  Every 30 minutes intraoperatively from endotracheal intubation until washout of anesthesia prior to extubation.

• Change of tracheal bacterial load immediately before extubation

  Immediately before extubation.

• Change of oral bacterial load 24 hours postoperatively

  Approximately 24 hours postoperatively, with a tolerance of ±2 hours.

• Qualitative microbiological characterization of bacteria detected in tracheal samples

  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

  From the start of the oral hygiene intervention until approximately 24 hours postoperatively.

Study Arms (2)

Standard of care

NO INTERVENTION

Standard clinical care without additional preoperative oral hygiene or oral decontamination measures before induction of general anesthesia.

Preoperative oral decontamination with chlorhexidine & tooth & tongue brushing

ACTIVE COMPARATOR

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

Interventions

Preoperative oral decontamination with chlorhexidine PROCEDURE

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.

Preoperative oral decontamination with chlorhexidine & tooth & tongue brushing

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Ulm: lead

Study Sites (1)

Ulm University Medical Center, Department of Anesthesiology and Intensive Care Medicine

Ulm, Baden-Wurttemberg, 89081, Germany

Location

Related Publications (9)

• Naumova EA, Weber L, Pankratz V, Czenskowski V, Arnold WH. Bacterial viability in oral biofilm after tooth brushing with amine fluoride or sodium fluoride. Arch Oral Biol. 2019 Jan;97:91-96. doi: 10.1016/j.archoralbio.2018.10.013. Epub 2018 Oct 17.

  PMID: 30368202 BACKGROUND

• Shuai Y, Wang X, Chen S, Huang T, Wang Z, Zhang Y. Preoperative oral hygiene treatment reduces bacterial transport and colonization during intubation for orthopedic surgery. J Oral Sci. 2024;66(2):134-138. doi: 10.2334/josnusd.23-0425.

  PMID: 38631883 BACKGROUND

• Okochi M, Nomura S, Kaga C, Honda H. Peptide array-based screening of human mesenchymal stem cell-adhesive peptides derived from fibronectin type III domain. Biochem Biophys Res Commun. 2008 Jun 20;371(1):85-9. doi: 10.1016/j.bbrc.2008.04.019. Epub 2008 Apr 14.

  PMID: 18413142 BACKGROUND

• Pneumatikos IA, Dragoumanis CK, Bouros DE. Ventilator-associated pneumonia or endotracheal tube-associated pneumonia? An approach to the pathogenesis and preventive strategies emphasizing the importance of endotracheal tube. Anesthesiology. 2009 Mar;110(3):673-80. doi: 10.1097/ALN.0b013e31819868e0.

  PMID: 19212256 BACKGROUND

• Fourrier F, Duvivier B, Boutigny H, Roussel-Delvallez M, Chopin C. Colonization of dental plaque: a source of nosocomial infections in intensive care unit patients. Crit Care Med. 1998 Feb;26(2):301-8. doi: 10.1097/00003246-199802000-00032.

  PMID: 9468169 BACKGROUND

• Scannapieco FA, Stewart EM, Mylotte JM. Colonization of dental plaque by respiratory pathogens in medical intensive care patients. Crit Care Med. 1992 Jun;20(6):740-5. doi: 10.1097/00003246-199206000-00007.

  PMID: 1597025 BACKGROUND

• Cozowicz C, Zhong H, Reisinger L, Illescas A, Giannakis P, Liu J, Poeran JV, Memtsoudis SG. Inpatient Cost of Complications after Total Hip and Knee Arthroplasty. Anesthesiology. 2026 Mar 1;144(3):611-621. doi: 10.1097/ALN.0000000000005856. Epub 2025 Nov 20.

  PMID: 41264388 BACKGROUND

• Martin CT, Gao Y, Pugely AJ. Incidence And Risk Factors For 30-Day Readmissions After Hip Fracture Surgery. Iowa Orthop J. 2016;36:155-60.

  PMID: 27528853 BACKGROUND

• Hui S, Fowler AJ, Cashmore RMJ, Fisher TJ, Schlautmann J, Body S, Lan-Pak-Kee V, Webb M, Kyriakides M, Ng JY, Chisvo NS, Pearse RM, Abbott TEF. Routine postoperative noninvasive respiratory support and pneumonia after elective surgery: a systematic review and meta-analysis of randomised trials. Br J Anaesth. 2022 Feb;128(2):363-374. doi: 10.1016/j.bja.2021.10.047. Epub 2021 Dec 13.

  PMID: 34916050 BACKGROUND

MeSH Terms

Interventions

Chlorhexidine

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Central Study Contacts

Béla-Simon Paschold, M.D.

CONTACT

+49-731-50060390; bela-simon.paschold@uniklinik-ulm.de

Physician on Duty

CONTACT

+49-731-50060043

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Professor of Anesthesiology and Intensive Care

Model Details: This study is a randomized, controlled, parallel-group trial comparing two groups: the intervention group receives preoperative oral decontamination. The control group receives standard clinical care without additional oral hygiene measures.

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 25, 2026
• Study Start: June 20, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)