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| Name | Class |
|---|---|
| Orlando Regional Medical Center | OTHER |
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Insertion of a breathing tube to enable treatment with mechanical ventilation (respirator) is often associated with complications, such as infection and lung injury. Leakage of secretions around the breathing tube (microaspiration) is a major factor leading to complications. The investigators propose that a standardized, enhanced oral suction protocol will be effective in reducing microaspiration and harms associated with mechanical ventilation. The investigators hypothesize that those randomized to the enhanced oral suction protocol will have less microaspiration and other ventilator-associated conditions than those in the usual care, standard suction group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced oral suction | Experimental | Deep oropharyngeal suction with catheter |
|
| Usual Care Oral Suction | Sham Comparator | Oropharyngeal suction with suction swab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced oropharyngeal suction | Other | Deep oropharyngeal suction with catheter every 4 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Microaspiration as Measured by Tracheal Amylase | Specimens will be obtained every 12 hours for up to 14 days or subject no longer meets inclusion (e.g., extubation, tracheostomy, etc.); tracheal amylase measured in U/L. | Every 12 hours up to 14 days |
| Microaspiration as Measured by Percentage of Tracheal Specimens Positive for Amylase Per Participant | Specimens will be obtained every 12 hours for up to 14 days or subject no longer meets inclusion criteria | Every 12 hours up to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilator-Associated Condition (VAC) Rate | VAC rate was calculated between control and intervention groups using the Centers for Disease Control and Prevention (2013) criteria. | VAC assessed for 2 days beyond last intervention; mean 5.4 days |
| Time to VAC |
| Measure | Description | Time Frame |
|---|---|---|
| Tracheal to Oral Ratio of Amylase | The ratio of the tracheal value to the oral value of amylase for each paired sample was calculated (ratio included baseline specimen collected). | Every 12 hours up to 14 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary L Sole, PhD | Univesity of Central Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Regional Medical Center | Orlando | Florida | 32806 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36116866 | Derived | Bourgault AM, Xie R, Talbert S, Sole ML. Association of enteral feeding with microaspiration in critically ill adults. Appl Nurs Res. 2022 Oct;67:151611. doi: 10.1016/j.apnr.2022.151611. Epub 2022 Jun 30. | |
| 34719715 | Derived | Talbert S, Bourgault AM, Rathbun KP, Abomoelak B, Deb C, Mehta D, Sole ML. Pepsin A in Tracheal Secretions From Patients Receiving Mechanical Ventilation. Am J Crit Care. 2021 Nov 1;30(6):443-450. doi: 10.4037/ajcc2021528. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Enhanced Oral Suction | Deep oropharyngeal suction with catheter every 4 hours; standard oral cleansing every 4 hours. |
| FG001 | Usual Care Oral Suction | Oral suction with suction swab every 4 hours; standard oral cleansing every 4 hours. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Enhanced Oral Suction | Deep oropharyngeal suction with catheter every 4 hours; standard oral cleansing every 4 hours. |
| BG001 | Usual Care Oral Suction | Oropharyngeal suction with suction swab; standard oral cleansing every 4 hours. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Microaspiration as Measured by Tracheal Amylase | Specimens will be obtained every 12 hours for up to 14 days or subject no longer meets inclusion (e.g., extubation, tracheostomy, etc.); tracheal amylase measured in U/L. | Posted | Mean | Standard Deviation | U/L | Every 12 hours up to 14 days |
|
Data were collected for the duration of participant enrollment in study (mean 5.4 days); range 1.5 to 14.0 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enhanced Oral Suction | Deep oropharyngeal suction with catheter every 4 hours; standard oral cleansing every 4 hours. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary Lou Sole | University of Central Florida | 407-823-5496 | mary.sole@ucf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 11, 2014 | Jul 23, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Usual Care | Other | Oral suction with suction swab every 4 hours |
|
| VAC was assessed for two days beyond the last intervention; mean 5.4 days |
| 31241194 | Derived | Sole ML, Talbert S, Yan X, Penoyer D, Mehta D, Bennett M, Emery KP, Middleton A, Deaton L, Abomoelak B, Deb C. Impact of deep oropharyngeal suctioning on microaspiration, ventilator events, and clinical outcomes: A randomized clinical trial. J Adv Nurs. 2019 Nov;75(11):3045-3057. doi: 10.1111/jan.14142. Epub 2019 Aug 7. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| APACHE 2 | Severity of illness; Range 0-71; higher number = greater severity; rare for scores to exceed 55 | Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Microaspiration as Measured by Percentage of Tracheal Specimens Positive for Amylase Per Participant | Specimens will be obtained every 12 hours for up to 14 days or subject no longer meets inclusion criteria | Posted | Number | percentage specimens positive amylase | Every 12 hours up to 14 days |
|
|
|
|
| Secondary | Ventilator-Associated Condition (VAC) Rate | VAC rate was calculated between control and intervention groups using the Centers for Disease Control and Prevention (2013) criteria. | Posted | Count of Participants | Participants | VAC assessed for 2 days beyond last intervention; mean 5.4 days |
|
|
|
|
| Secondary | Time to VAC | Posted | Mean | Standard Deviation | Days | VAC was assessed for two days beyond the last intervention; mean 5.4 days |
|
|
|
| Other Pre-specified | Tracheal to Oral Ratio of Amylase | The ratio of the tracheal value to the oral value of amylase for each paired sample was calculated (ratio included baseline specimen collected). | Posted | Mean | Standard Deviation | Ratio of tracheal amylase to oral value | Every 12 hours up to 14 days |
|
|
|
|
| Post-Hoc | Clinical Outcome: Ventilator Hours | Posted | Mean | Standard Deviation | Hours | Duration of Mechanical Ventilation |
|
|
|
|
| Post-Hoc | Clinical Outcome: Intensive Care Unit Length of Stay | Posted | Mean | Standard Deviation | Days | Duration of Intensive Care Unit Stay |
|
|
|
|
| Post-Hoc | Clinical Outcome: Hospital Length of Stay | Posted | Mean | Standard Deviation | Days | Duration of Hospital Stay |
|
|
|
|
| 41 |
| 206 |
| 0 |
| 206 |
| 0 |
| 206 |
| EG001 | Usual Care Oral Suction | Oral suction with suction swab every 4 hours; standard oral cleansing every 4 hours. | 49 | 204 | 0 | 204 | 0 | 204 |
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