Esophageal Cancer, Lung Cancer, Post-operative Pneumonia
Conditions
Keywords
Incidence of post-operative pneumonia in patients undergoing surgery for primary lung cancer or primary esophageal cancer
Brief summary
Postoperative pneumonia is a major complication in patients undergoing thoracic surgery. It leads to considerable morbidity and contributes to perioperative morbidity. There is evidence in literature that supports the use of strategies for improved oral hygiene and specialized endotracheal tubes in preventing ventilator associated pneumonia (VAP) in mechanically ventilated patients. This study aims at utilizing a combination of these interventions in the perioperative period in patients undergoing planned thoracic surgical procedures.
Interventions
Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution and for the duration of the hospitalization or 5 days postoperatively.
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with lung lesions undergoing anatomic resection (lobectomy/segmentectomy/bilobectomy/pulmonary sleeve resection/pneumonectomy) 2. Patients with poor lung function (FEV1% \<50% or DLCO\<50% predicted or home oxygen requirement) and lung lesions undergoing non-anatomic lung resection (i.e. wedge resection). 3. Patients undergoing esophageal resection.
Exclusion criteria
1. Patients with ongoing symptomatic dental infections. 2. Patients with recent/ongoing pneumonia (\<15 days from initial surgical patient evaluation). 3. Patients who've received a therapeutic course of antibiotics within 15 days prior to thoracic surgery. 4. Patients with a preexisting tracheostomy. 5. Age\<18 6. Patients with an allergy to Peridex/chlorhexidine solution
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Develop Postoperative Pneumonia in the Two Groups: Lung Cancer Resection Patients and Esophageal Resection Patients | Within 30 days of surgery | Patients will be considered to have postoperative pneumonia if they meet three of the following criteria within 30 days after surgery; 1. Fever (Temperature \>38.2 C) 2. Leucocytosis (WBC\>12,000/cu mm) 3. New infiltrate on chest X-ray 4. Positive sputum or bronchial culture 5. Treatment with antibiotics These criteria are utilized by the national Society of Thoracic Surgeons' database. |
| Adherence to the Pre-operative Toothbrushing Regimen | Completion of pre-operative toothbrushing (three times a day for 5 days prior to surgery) | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative Mortality | Within 30 days of surgery | — |
| Compliance With Oral Hygiene Regimen as Measured by a Daily Brushing Diary | Within 30 days of surgery (comparing pre-op and post-op) | — |
| Incidence of Fever | Within 24 hours of surgery | — |
| Postoperative Respiratory Failure | Within 30 days of surgery | Postoperative respiratory failure = need for postoperative mechanical ventilation, need for bronchoscopy for atelectasis, need for tracheostomy |
| Compliance With Oral Hygiene Regimen as Measured by the Number of Participants Who Completed the Modified Morisky Medication/Intervention Adherence Scale and Knowledge Questionnaire | Within 30 days of surgery | Compliance is measured by the number of participants who completed the Modified Morisky Medication/Intervention Adherence Scale and Knowledge Questionnaire |
Countries
United States
Participant flow
Recruitment details
The study opened to participant enrollment on 09/22/2011 and closed to participant enrollment on 06/08/2016.
Participants by arm
| Arm | Count |
|---|---|
| Pre-operative Brushing (Pilot Portion) -Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution | 20 |
| Pre-operative & Post-Operative Brushing (Esophageal Resection) * Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution
* The intensive toothbrushing regimen and chlorhexidine mouthwash will be continued for the duration of the hospitalization or a minimum of 5 days postoperatively in the study group. | 50 |
| Pre-operative & Post-Operative Brushing (Lung Resection) * Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution
* The intensive toothbrushing regimen and chlorhexidine mouthwash will be continued for the duration of the hospitalization or a minimum of 5 days postoperatively in the study group. | 62 |
| Total | 132 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Antibiotics for pre-op infection | 0 | 0 | 2 |
| Overall Study | Non-compliance | 0 | 4 | 0 |
| Overall Study | No surgery/No qualifying surgery | 1 | 0 | 12 |
| Overall Study | Not eligible | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 4 |
Baseline characteristics
| Characteristic | Pre-operative & Post-Operative Brushing (Esophageal Resection) | Pre-operative & Post-Operative Brushing (Lung Resection) | Total | Pre-operative Brushing (Pilot Portion) |
|---|---|---|---|---|
| Age, Continuous | 58 years | 63 years | 62 years | 66 years |
| Region of Enrollment United States | 50 Participants | 62 Participants | 132 Participants | 20 Participants |
| Sex: Female, Male Female | 9 Participants | 29 Participants | 45 Participants | 7 Participants |
| Sex: Female, Male Male | 41 Participants | 33 Participants | 87 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 50 | 1 / 62 |
| serious Total, serious adverse events | 0 / 20 | 0 / 50 | 0 / 62 |
Outcome results
Primary
Adherence to the Pre-operative Toothbrushing Regimen
Time frame: Completion of pre-operative toothbrushing (three times a day for 5 days prior to surgery)
Population: This outcome measure was for only the pilot portion of the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pre-operative Brushing (Pilot Portion) | Adherence to the Pre-operative Toothbrushing Regimen | 16 Participants |
Primary
Number of Participants Who Develop Postoperative Pneumonia in the Two Groups: Lung Cancer Resection Patients and Esophageal Resection Patients
Patients will be considered to have postoperative pneumonia if they meet three of the following criteria within 30 days after surgery; 1. Fever (Temperature \>38.2 C) 2. Leucocytosis (WBC\>12,000/cu mm) 3. New infiltrate on chest X-ray 4. Positive sputum or bronchial culture 5. Treatment with antibiotics These criteria are utilized by the national Society of Thoracic Surgeons' database.
Time frame: Within 30 days of surgery
Population: -None of the participants from the pilot portion are included in this outcome measure as the pilot portion only measured compliance of pre-operative toothbrushing.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pre-operative & Post-Operative Brushing (Esophageal Resection) | Number of Participants Who Develop Postoperative Pneumonia in the Two Groups: Lung Cancer Resection Patients and Esophageal Resection Patients | 5 Participants |
| Pre-operative & Post-Operative Brushing (Lung Resection) | Number of Participants Who Develop Postoperative Pneumonia in the Two Groups: Lung Cancer Resection Patients and Esophageal Resection Patients | 1 Participants |
Secondary
Compliance With Oral Hygiene Regimen as Measured by a Daily Brushing Diary
Time frame: Within 30 days of surgery (comparing pre-op and post-op)
Population: The Pilot Portion is not included in this outcome measure. 3 participants in the esophageal resection group was not evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pre-operative & Post-Operative Brushing (Esophageal Resection) | Compliance With Oral Hygiene Regimen as Measured by a Daily Brushing Diary | Pre-op (compliant ≥ 80% of the time) | 39 Participants |
| Pre-operative & Post-Operative Brushing (Esophageal Resection) | Compliance With Oral Hygiene Regimen as Measured by a Daily Brushing Diary | Pre-op (compliant 60-79.9% of the time) | 4 Participants |
| Pre-operative & Post-Operative Brushing (Esophageal Resection) | Compliance With Oral Hygiene Regimen as Measured by a Daily Brushing Diary | Pre-op (compliant 40-59.9% of the time) | 0 Participants |
| Pre-operative & Post-Operative Brushing (Esophageal Resection) | Compliance With Oral Hygiene Regimen as Measured by a Daily Brushing Diary | Pre-op (compliant ≤39.9% of the time) | 0 Participants |
| Pre-operative & Post-Operative Brushing (Esophageal Resection) | Compliance With Oral Hygiene Regimen as Measured by a Daily Brushing Diary | Post-op (compliant ≥ 80% of the time) | 26 Participants |
| Pre-operative & Post-Operative Brushing (Esophageal Resection) | Compliance With Oral Hygiene Regimen as Measured by a Daily Brushing Diary | Post-op (compliant 60-79.9% of the time) | 3 Participants |
| Pre-operative & Post-Operative Brushing (Esophageal Resection) | Compliance With Oral Hygiene Regimen as Measured by a Daily Brushing Diary | Post-op (compliant 40-59.9% of the time) | 6 Participants |
| Pre-operative & Post-Operative Brushing (Esophageal Resection) | Compliance With Oral Hygiene Regimen as Measured by a Daily Brushing Diary | Post-op (compliant ≤39.9% of the time) | 8 Participants |
| Pre-operative & Post-Operative Brushing (Lung Resection) | Compliance With Oral Hygiene Regimen as Measured by a Daily Brushing Diary | Post-op (compliant ≤39.9% of the time) | 22 Participants |
| Pre-operative & Post-Operative Brushing (Lung Resection) | Compliance With Oral Hygiene Regimen as Measured by a Daily Brushing Diary | Pre-op (compliant ≥ 80% of the time) | 50 Participants |
| Pre-operative & Post-Operative Brushing (Lung Resection) | Compliance With Oral Hygiene Regimen as Measured by a Daily Brushing Diary | Post-op (compliant ≥ 80% of the time) | 28 Participants |
| Pre-operative & Post-Operative Brushing (Lung Resection) | Compliance With Oral Hygiene Regimen as Measured by a Daily Brushing Diary | Pre-op (compliant 60-79.9% of the time) | 9 Participants |
| Pre-operative & Post-Operative Brushing (Lung Resection) | Compliance With Oral Hygiene Regimen as Measured by a Daily Brushing Diary | Post-op (compliant 40-59.9% of the time) | 5 Participants |
| Pre-operative & Post-Operative Brushing (Lung Resection) | Compliance With Oral Hygiene Regimen as Measured by a Daily Brushing Diary | Pre-op (compliant 40-59.9% of the time) | 1 Participants |
| Pre-operative & Post-Operative Brushing (Lung Resection) | Compliance With Oral Hygiene Regimen as Measured by a Daily Brushing Diary | Post-op (compliant 60-79.9% of the time) | 7 Participants |
| Pre-operative & Post-Operative Brushing (Lung Resection) | Compliance With Oral Hygiene Regimen as Measured by a Daily Brushing Diary | Pre-op (compliant ≤39.9% of the time) | 2 Participants |
Secondary
Compliance With Oral Hygiene Regimen as Measured by the Number of Participants Who Completed the Modified Morisky Medication/Intervention Adherence Scale and Knowledge Questionnaire
Compliance is measured by the number of participants who completed the Modified Morisky Medication/Intervention Adherence Scale and Knowledge Questionnaire
Time frame: Within 30 days of surgery
Population: None of the participants from the pilot portion are included in this outcome measure as the pilot portion only measured compliance of pre-operative toothbrushing and the participants did not complete the questionnaire.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pre-operative & Post-Operative Brushing (Esophageal Resection) | Compliance With Oral Hygiene Regimen as Measured by the Number of Participants Who Completed the Modified Morisky Medication/Intervention Adherence Scale and Knowledge Questionnaire | 46 Participants |
| Pre-operative & Post-Operative Brushing (Lung Resection) | Compliance With Oral Hygiene Regimen as Measured by the Number of Participants Who Completed the Modified Morisky Medication/Intervention Adherence Scale and Knowledge Questionnaire | 62 Participants |
Secondary
Incidence of Fever
Time frame: Within 24 hours of surgery
Population: None of the participants from the pilot portion are included in this outcome measure as the pilot portion only measured compliance of pre-operative toothbrushing.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pre-operative & Post-Operative Brushing (Esophageal Resection) | Incidence of Fever | 7 Participants |
| Pre-operative & Post-Operative Brushing (Lung Resection) | Incidence of Fever | 0 Participants |
Secondary
Perioperative Mortality
Time frame: Within 30 days of surgery
Population: None of the participants from the pilot portion are included in this outcome measure as the pilot portion only measured compliance of pre-operative toothbrushing.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pre-operative & Post-Operative Brushing (Esophageal Resection) | Perioperative Mortality | 0 Participants |
| Pre-operative & Post-Operative Brushing (Lung Resection) | Perioperative Mortality | 3 Participants |
Secondary
Postoperative Respiratory Failure
Postoperative respiratory failure = need for postoperative mechanical ventilation, need for bronchoscopy for atelectasis, need for tracheostomy
Time frame: Within 30 days of surgery
Population: None of the participants from the pilot portion are included in this outcome measure as the pilot portion only measured compliance of pre-operative toothbrushing.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pre-operative & Post-Operative Brushing (Esophageal Resection) | Postoperative Respiratory Failure | Bronchoscopy for atelectasis | 1 Participants |
| Pre-operative & Post-Operative Brushing (Esophageal Resection) | Postoperative Respiratory Failure | Trachestomy | 1 Participants |
| Pre-operative & Post-Operative Brushing (Esophageal Resection) | Postoperative Respiratory Failure | Respiratory failure | 5 Participants |
| Pre-operative & Post-Operative Brushing (Esophageal Resection) | Postoperative Respiratory Failure | Reintubation | 4 Participants |
| Pre-operative & Post-Operative Brushing (Lung Resection) | Postoperative Respiratory Failure | Reintubation | 0 Participants |
| Pre-operative & Post-Operative Brushing (Lung Resection) | Postoperative Respiratory Failure | Bronchoscopy for atelectasis | 1 Participants |
| Pre-operative & Post-Operative Brushing (Lung Resection) | Postoperative Respiratory Failure | Respiratory failure | 5 Participants |
| Pre-operative & Post-Operative Brushing (Lung Resection) | Postoperative Respiratory Failure | Trachestomy | 1 Participants |