Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective is to determine the optimal intraoperative ventilation strategy among the chosen tidal volume and positive end-expiratory pressure (PEEP) levels, and standardize it in an enhanced recovery pathway for orthopedic surgical patients. In particular, we propose to determine which combination of intraoperative tidal volume and positive end-expiratory pressure is best for patients having elective orthopedic surgery.
This is a non-randomized alternating intervention cohort study in which all orthopedic surgery operating rooms will alternate amongst four designated ventilation settings which include two tidal volumes and two PEEP levels. At the end of the four-week sequence, the entire sequence will be repeated 26 times over a 2-year period. Thus, ventilator settings will not be randomized on a per-patient basis, or even among study weeks.
Ventilation parameters will be designated at the beginning of each study week. However, clinicians will be free to adjust to whatever ventilation settings they believe is optimal in individual patients to ensure oxygenation and patient safety.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low tidal volume and low PEEP | Experimental | Ventilation parameters will be set at tidal volume = 6 ml/ kg predicted body weight, and PEEP = 5 cm water (H2O). |
|
| Low tidal volume and high PEEP | Experimental | Ventilation parameters will be set at tidal volume = 6 ml/kg predicted body weight, and PEEP = 8 cm H2O. |
|
| High tidal volume and low PEEP | Experimental | Ventilation parameters will be set at tidal volume = 10 ml/kg predicted body weight, and PEEP = 5cm H2O. |
|
| High tidal volume and high PEEP | Experimental | Ventilation parameters will be set at tidal volume = 10 ml/kg predicted body weight, and PEEP = 8cm H2O. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low tidal Volume | Procedure | Tidal volume = 6 ml/kg predicted body weight |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time-weighted Average SaO2/FiO2 Ratio in the Postanesthesia Care Unit (PACU) | Primary outcome was oxygenation in the postoperative care unit, defined by the peripheral oxygen saturation divided by the fraction of inspired oxygen (SpO2/FiO2 ratio), a validated measure of acute lung injury. | After surgery until discharged from PACU or up to 90 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of Serious Postoperative Pulmonary Complications | Postoperative diagnoses will be collected from electronic medical records of patients. Individual chart reviews (blinded to ventilation management) will confirm that terms of the composite are met will be performed. | After surgery from 2 to 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Patients Need of Oxygen in Ward After Surgery | number of patients who need of Oxygen in ward after surgery during hospital stay | from out of operation room to discharge from the hospital |
| Patients With Unplanned ICU Admission |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alparslan Turan, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
Data will be shared on a collaborative basis.
After publication of the primary manuscript.
Data will be shared on a collaborative basis with investigators who plan substantive sub-analyses.
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Low Tidal Volume and Low PEEP | Ventilation parameters will be set at tidal volume = 6 ml/ kg predicted body weight, and PEEP = 5 cm water (H2O). (n = 727) Low tidal Volume: Tidal volume = 6 ml/kg predicted body weight Low PEEP: PEEP = 5 cm H2O |
| FG001 | Low Tidal Volume and High PEEP | Ventilation parameters will be set at tidal volume = 6 ml/kg predicted body weight, and PEEP = 8 cm H2O. (n = 635) Low tidal Volume: Tidal volume = 6 ml/kg predicted body weight High PEEP: PEEP = 8 cm H2O |
| FG002 | High Tidal Volume and Low PEEP | Ventilation parameters will be set at tidal volume = 10 ml/kg predicted body weight, and PEEP = 5cm H2O. (n = 799) High tidal Volume: Tidal volume = 10 ml/kg predicted body weight Low PEEP: PEEP = 5 cm H2O |
| FG003 | High Tidal Volume and High PEEP | Ventilation parameters will be set at tidal volume = 10 ml/kg predicted body weight, and PEEP = 8cm H2O. (n = 699) High tidal Volume: Tidal volume = 10 ml/kg predicted body weight High PEEP: PEEP = 8 cm H2O |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Low Tidal Volume and Low PEEP | Ventilation parameters will be set at tidal volume = 6 ml/ kg predicted body weight, and PEEP = 5 cm water (H2O). (n = 727) Low tidal Volume: Tidal volume = 6 ml/kg predicted body weight Low PEEP: PEEP = 5 cm H2O |
| BG001 | Low Tidal Volume and High PEEP |
| 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 | Time-weighted Average SaO2/FiO2 Ratio in the Postanesthesia Care Unit (PACU) | Primary outcome was oxygenation in the postoperative care unit, defined by the peripheral oxygen saturation divided by the fraction of inspired oxygen (SpO2/FiO2 ratio), a validated measure of acute lung injury. | The mean difference was estimated from a linear mixed regression model with surgeries from same patient as repeated measures, after propensity score weighting. | Posted | Mean | Standard Deviation | ratio | After surgery until discharged from PACU or up to 90 minutes |
|
1 week.
None observed
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Tidal Volume and Low PEEP | tidal volume = 6 ml/kg and PEEP = 5 cmH2O | 0 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| YanYan Han | Cleveland Clinic Foundation | 216-444-2250 | HANY3@ccf.org |
Not provided
| 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 20, 2020 | Jul 3, 2024 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| High tidal Volume | Procedure | Tidal volume = 10 ml/kg predicted body weight |
|
| Low PEEP | Procedure | PEEP = 5 cm H2O |
|
| High PEEP | Procedure | PEEP = 8 cm H2O |
|
| Oxygenation in Ward, Defined as Time Weighted Average (TWA) of SaO2/FIO2 Ratio |
Oxygen administration and SaO2 are normally recorded at 4-hour intervals on surgical wards. The time weighted average (TWA) of overall SaO2/FIO2 ratio will be compared among different ventilation strategies. |
| After surgery from 2 to 5 days |
| Length of Postoperative Hospital Stay by Days | The days of postoperative hospitalization, which from out of operation room to discharge from the hospital, an average of 1 week | from out of operation room to discharge |
number of patients with unplanned ICU admission after surgery in hospital stay
| from out of operation room to discharge from the hospital |
Ventilation parameters will be set at tidal volume = 6 ml/kg predicted body weight, and PEEP = 8 cm H2O. (n = 635) Low tidal Volume: Tidal volume = 6 ml/kg predicted body weight High PEEP: PEEP = 8 cm H2O |
| BG002 | High Tidal Volume and Low PEEP | Ventilation parameters will be set at tidal volume = 10 ml/kg predicted body weight, and PEEP = 5cm H2O. (n = 799) High tidal Volume: Tidal volume = 10 ml/kg predicted body weight Low PEEP: PEEP = 5 cm H2O |
| BG003 | High Tidal Volume and High PEEP | Ventilation parameters will be set at tidal volume = 10 ml/kg predicted body weight, and PEEP = 8cm H2O. (n = 699) High tidal Volume: Tidal volume = 10 ml/kg predicted body weight High PEEP: PEEP = 8 cm H2O |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| ASA score | The ASA score refers to the American Society of Anesthesiologists (ASA) Physical Status Classification System, which is used to assess the preoperative physical health of a patient before surgery. ASA score and measure description: I: A normal, healthy patient. II: A patient with mild systemic disease. III: A patient with severe systemic disease. IV: A patient with severe systemic disease that is a constant threat to life. V: A moribund patient who is not expected to survive without the operation. VI: A declared brain-dead patient whose organs are being removed for donor purposes. | Count of Participants | Participants |
|
| The total Charlson score | The Charlson Comorbidity Index (CCI), it is a weighted score used to predict the risk of mortality or adverse outcomes by assessing the presence of various comorbid conditions (chronic diseases or medical conditions). Each condition is assigned a specific weight (from 1 to 6 points) based on the associated risk of mortality. e.g. Dementia scored 1, Metastatic solid tumor scored 6. The total Charlson score is the sum of the CCI for all conditions that a patient has. A higher score indicates a higher risk of death or complications due to the comorbidities. The range is 0 to 37 or higher. | Median | Inter-Quartile Range | units on a scale |
|
| smoking | Count of Participants | Participants |
|
| COPD | Count of Participants | Participants |
|
| Obstructive sleep apnea | Count of Participants | Participants |
|
| Asthma | Count of Participants | Participants |
|
| intraoperative use of Rocuronium | Median | Inter-Quartile Range | mg |
|
| Crystalloids | Mean | Standard Deviation | L |
|
| blood loss | Median | Inter-Quartile Range | ml |
|
| transfusion | Count of Participants | Participants |
|
| OG002 | PEEP = 5cmH2O | Positive End-Expiratory Pressure = 5cmH2O |
| OG003 | PEEP = 8cmH2O | Positive End-Expiratory Pressure = 8cmH2O |
|
|
|
| Secondary | Composite of Serious Postoperative Pulmonary Complications | Postoperative diagnoses will be collected from electronic medical records of patients. Individual chart reviews (blinded to ventilation management) will confirm that terms of the composite are met will be performed. | Posted | Number | person | After surgery from 2 to 5 days |
|
|
|
|
| Secondary | Oxygenation in Ward, Defined as Time Weighted Average (TWA) of SaO2/FIO2 Ratio | Oxygen administration and SaO2 are normally recorded at 4-hour intervals on surgical wards. The time weighted average (TWA) of overall SaO2/FIO2 ratio will be compared among different ventilation strategies. | Posted | Mean | Standard Deviation | ratio | After surgery from 2 to 5 days |
|
|
|
|
| Secondary | Length of Postoperative Hospital Stay by Days | The days of postoperative hospitalization, which from out of operation room to discharge from the hospital, an average of 1 week | Posted | Median | Inter-Quartile Range | days | from out of operation room to discharge |
|
|
|
|
| Other Pre-specified | Patients Need of Oxygen in Ward After Surgery | number of patients who need of Oxygen in ward after surgery during hospital stay | Posted | Number | participants | from out of operation room to discharge from the hospital |
|
|
|
| Other Pre-specified | Patients With Unplanned ICU Admission | number of patients with unplanned ICU admission after surgery in hospital stay | Posted | Number | participants | from out of operation room to discharge from the hospital |
|
|
|
| 727 |
| 0 |
| 727 |
| 0 |
| 727 |
| EG001 | High Tidal Volume and Low PEEP | tidal volume = 10 ml/kg and PEEP = 5 cmH2O | 0 | 635 | 0 | 635 | 0 | 635 |
| EG002 | Low Tidal Volume and High PEEP | tidal volume = 6 ml/kg and PEEP = 8 cmH2O | 0 | 799 | 0 | 799 | 0 | 799 |
| EG003 | High Tidal Volume and High PEEP | tidal volume = 10 ml/kg and PEEP = 8 cmH2O | 0 | 699 | 0 | 699 | 0 | 699 |
Not provided
Not provided
Not provided
| Odds Ratio (OR) |
| 0.87 |
| 2-Sided |
| 99.2 |
| 0.63 |
| 1.19 |
| Superiority |
| Mean Difference (Final Values) |
| 0.7 |
| 2-Sided |
| 99.2 |
| -3.7 |
| 5.2 |
| Superiority |
| mean ratio |
| 0.99 |
| 2-Sided |
| 99.2 |
| 0.93 |
| 1.05 |
| Superiority |