Impact of Oral Care on Ventilator Associated Pneumonia (OH-VAP)

Ain Shams University

Status: Completed

Conditions: Ventilator Associated Pneumonia ( VAP)

Treatments: Procedure: Routine oral care + Chlorohexidine; Procedure: Toothbrushing + Chlorhexidine

Study type: Interventional

Funder types: Other

Identifiers

NCT07287566

FMASU MS407 /2024

FMA MS407 /2024 (Other Identifier)

Details and patient eligibility

About

The goal of this clinical trial was to find out whether cleaning the mouths of children in the Pediatric Intensive Care Unit (PICU) with toothbrushing and chlorhexidine lowers the chance of getting lung infections in patients on breathing machines compared to routine mouth care. The study determined whether this approach changed how long children need a breathing machine, how many days they stayed in the PICU, and whether it affects survival. The main questions it aimed to answer were:

• Did toothbrushing with chlorhexidine, compared to routine mouth care, lowered the risk of lung infections in patients on breathing machines in the PICU?
• Did this approach also affect recovery outcomes, including duration of needing a breathing machine, length of PICU stay, and survival rates?

Researchers compared toothbrushing and chlorhexidine to routine mouth care to see if toothbrushing and chlorhexidine lowered the risk of lung infections in patients on breathing machines.

Participants:

Had safety practices to prevent lung infections in patients on breathing machines Had toothbrushing and chlorhexidine or routine mouth care three times daily 5 minutes in each Had physical check-up and any tests needed as part of their care

Full description

Pediatric dentist trained the nurses to follow the proper oral care protocol. Safe practices as keeping the patient's head slightly raised while lying in bed and clean the patients mouth regularly to remove germs. Participants and researcher didn't know which oral care method was being administered making this double blinded study. The participants were divided into two groups 59 patients in each group. In Tooth brushing group, tooth paste and soft tooth brush was positioned at 45 degree angle with a firm gentle pressure, brushing back and forth or using a circular motion 15 to 20 times before moving to the next area for one minute plus application of chlorhexidine mouthwash to a swab on the oral mucosa, teeth, gums, hard palate, and tongue, followed by 20 milliliter (mL) of normal saline, the procedure was finished with hypo pharyngeal suctioning. In routine oral care group only a swab with chlorhexidine and rubbing it on the surface of the tongue, gum and mucosa followed by 20 mL of normal saline, the procedure was finished with hypo pharyngeal suctioning.

investigations include laboratory (Complete blood picture, C-reactive protein and Venous blood gases (VBG) were done. Radiological and microbiological included sputum culture collected on fifth day were also done.

Enrollment: 118 patients

Sex: All

Ages: 18 months to 16 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: dentate mechanically ventilated

-

Exclusion Criteria:

• primary immune deficiency coagulation disorders jaw fractures

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

118 participants in 2 patient groups

intervention group

Experimental group

Description:

Toothbrushing + Chlorohexidine

Treatment:

Procedure: Toothbrushing + Chlorhexidine

control group

Active Comparator group

Description:

Routine oral care + Chlorohexidine

Treatment:

Procedure: Routine oral care + Chlorohexidine