Orthopedic Surgery, Ventilation
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREHigh PEEP
PEEP = 8 cm H2O
PROCEDURELow tidal Volume
Tidal volume = 6 ml/kg predicted body weight
PROCEDUREHigh tidal Volume
Tidal volume = 10 ml/kg predicted body weight
PROCEDURELow PEEP
PEEP = 5 cm H2O
Sponsors
The Cleveland Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Surgery in orthopedic operating rooms 32-37 * General anesthesia with endotracheal intubation.
Exclusion criteria
* Non-orthopedic procedures; * Intubation before induction of anesthesia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time-weighted Average SaO2/FiO2 Ratio in the Postanesthesia Care Unit (PACU) | After surgery until discharged from PACU or up to 90 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite of Serious Postoperative Pulmonary Complications | After surgery from 2 to 5 days | 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. |
| Oxygenation in Ward, Defined as Time Weighted Average (TWA) of SaO2/FIO2 Ratio | After surgery from 2 to 5 days | 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. |
| Length of Postoperative Hospital Stay by Days | from out of operation room to discharge | The days of postoperative hospitalization, which from out of operation room to discharge from the hospital, an average of 1 week |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patients Need of Oxygen in Ward After Surgery | from out of operation room to discharge from the hospital | number of patients who need of Oxygen in ward after surgery during hospital stay |
| Patients With Unplanned ICU Admission | from out of operation room to discharge from the hospital | number of patients with unplanned ICU admission after surgery in hospital stay |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 727 |
| 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 | 635 |
| 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 | 799 |
| 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 | 699 |
| Total | 2,860 |
Baseline characteristics
| Characteristic | Low Tidal Volume and Low PEEP | High Tidal Volume and Low PEEP | Total | Low Tidal Volume and High PEEP | High Tidal Volume and High PEEP |
|---|---|---|---|---|---|
| Age, Continuous | 64 years STANDARD_DEVIATION 15 | 62 years STANDARD_DEVIATION 15 | 63 years STANDARD_DEVIATION 14 | 64 years STANDARD_DEVIATION 14 | 63 years STANDARD_DEVIATION 14 |
| ASA score 1 | 23 Participants | 10 Participants | 56 Participants | 9 Participants | 14 Participants |
| ASA score 2 | 122 Participants | 157 Participants | 505 Participants | 106 Participants | 120 Participants |
| ASA score 3 | 519 Participants | 572 Participants | 2071 Participants | 460 Participants | 520 Participants |
| ASA score 4 or 5 | 63 Participants | 60 Participants | 228 Participants | 60 Participants | 45 Participants |
| Asthma | 119 Participants | 157 Participants | 483 Participants | 105 Participants | 102 Participants |
| blood loss | 150 ml | 200 ml | 150 ml | 150 ml | 150 ml |
| BMI | 30 kg/m2 STANDARD_DEVIATION 7 | 31 kg/m2 STANDARD_DEVIATION 8 | 31 kg/m2 STANDARD_DEVIATION 7 | 30 kg/m2 STANDARD_DEVIATION 7 | 32 kg/m2 STANDARD_DEVIATION 7 |
| COPD | 87 Participants | 103 Participants | 377 Participants | 85 Participants | 102 Participants |
| Crystalloids | 1.7 L STANDARD_DEVIATION 0.8 | 1.8 L STANDARD_DEVIATION 0.8 | 1.7 L STANDARD_DEVIATION 0.8 | 1.7 L STANDARD_DEVIATION 0.8 | 1.7 L STANDARD_DEVIATION 0.8 |
| intraoperative use of Rocuronium | 70 mg | 70 mg | 68 mg | 70 mg | 65 mg |
| Obstructive sleep apnea | 161 Participants | 202 Participants | 694 Participants | 144 Participants | 187 Participants |
| Race/Ethnicity, Customized race Black | 97 Participants | 115 Participants | 409 Participants | 108 Participants | 89 Participants |
| Race/Ethnicity, Customized race missing | 11 Participants | 14 Participants | 42 Participants | 4 Participants | 13 Participants |
| Race/Ethnicity, Customized race other | 16 Participants | 15 Participants | 65 Participants | 12 Participants | 22 Participants |
| Race/Ethnicity, Customized race White | 603 Participants | 655 Participants | 2344 Participants | 511 Participants | 575 Participants |
| Sex: Female, Male Female | 360 Participants | 442 Participants | 1504 Participants | 326 Participants | 376 Participants |
| Sex: Female, Male Male | 367 Participants | 357 Participants | 1356 Participants | 309 Participants | 323 Participants |
| smoking | 369 Participants | 404 Participants | 1460 Participants | 346 Participants | 341 Participants |
| The total Charlson score | 1 units on a scale | 1 units on a scale | 1 units on a scale | 1 units on a scale | 1 units on a scale |
| transfusion | 48 Participants | 75 Participants | 223 Participants | 50 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 727 | 0 / 635 | 0 / 799 | 0 / 699 |
| other Total, other adverse events | 0 / 727 | 0 / 635 | 0 / 799 | 0 / 699 |
| serious Total, serious adverse events | 0 / 727 | 0 / 635 | 0 / 799 | 0 / 699 |
Outcome results
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.
Time frame: After surgery until discharged from PACU or up to 90 minutes
Population: The mean difference was estimated from a linear mixed regression model with surgeries from same patient as repeated measures, after propensity score weighting.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TV = 6 ml/kg | Time-weighted Average SaO2/FiO2 Ratio in the Postanesthesia Care Unit (PACU) | 355 ratio | Standard Deviation 46 |
| TV = 10 ml/kg | Time-weighted Average SaO2/FiO2 Ratio in the Postanesthesia Care Unit (PACU) | 350 ratio | Standard Deviation 47 |
| PEEP = 5cmH2O | Time-weighted Average SaO2/FiO2 Ratio in the Postanesthesia Care Unit (PACU) | 353 ratio | Standard Deviation 46 |
| PEEP = 8cmH2O | Time-weighted Average SaO2/FiO2 Ratio in the Postanesthesia Care Unit (PACU) | 352 ratio | Standard Deviation 47 |
p-value: 0.04297.5% CI: [-0.4, 7.3]Regression, Linear
p-value: 0.96697.5% CI: [-3.9, 3.7]Regression, Linear
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.
Time frame: After surgery from 2 to 5 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TV = 6 ml/kg | Composite of Serious Postoperative Pulmonary Complications | 34 person |
| TV = 10 ml/kg | Composite of Serious Postoperative Pulmonary Complications | 39 person |
| PEEP = 5cmH2O | Composite of Serious Postoperative Pulmonary Complications | 36 person |
| PEEP = 8cmH2O | Composite of Serious Postoperative Pulmonary Complications | 37 person |
p-value: 0.51999.2% CI: [0.68, 1.27]Regression, Logistic
p-value: 0.23299.2% CI: [0.63, 1.19]Regression, Logistic
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
Time frame: from out of operation room to discharge
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TV = 6 ml/kg | Length of Postoperative Hospital Stay by Days | 3 days |
| TV = 10 ml/kg | Length of Postoperative Hospital Stay by Days | 3 days |
| PEEP = 5cmH2O | Length of Postoperative Hospital Stay by Days | 3 days |
| PEEP = 8cmH2O | Length of Postoperative Hospital Stay by Days | 3 days |
p-value: 0.14399.2% CI: [0.97, 1.1]Mixed Models Analysis
p-value: 0.64999.2% CI: [0.93, 1.05]Regression, Logistic
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.
Time frame: After surgery from 2 to 5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TV = 6 ml/kg | Oxygenation in Ward, Defined as Time Weighted Average (TWA) of SaO2/FIO2 Ratio | 428 ratio | Standard Deviation 42 |
| TV = 10 ml/kg | Oxygenation in Ward, Defined as Time Weighted Average (TWA) of SaO2/FIO2 Ratio | 430 ratio | Standard Deviation 41 |
| PEEP = 5cmH2O | Oxygenation in Ward, Defined as Time Weighted Average (TWA) of SaO2/FIO2 Ratio | 429 ratio | Standard Deviation 41 |
| PEEP = 8cmH2O | Oxygenation in Ward, Defined as Time Weighted Average (TWA) of SaO2/FIO2 Ratio | 429 ratio | Standard Deviation 41 |
p-value: 0.21799.2% CI: [-6.5, 2.4]Regression, Linear
p-value: 0.6699.2% CI: [-3.7, 5.2]Regression, Linear
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
Time frame: from out of operation room to discharge from the hospital
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TV = 6 ml/kg | Patients Need of Oxygen in Ward After Surgery | 855 participants |
| TV = 10 ml/kg | Patients Need of Oxygen in Ward After Surgery | 932 participants |
| PEEP = 5cmH2O | Patients Need of Oxygen in Ward After Surgery | 961 participants |
| PEEP = 8cmH2O | Patients Need of Oxygen in Ward After Surgery | 826 participants |
Other Pre-specified
Patients With Unplanned ICU Admission
number of patients with unplanned ICU admission after surgery in hospital stay
Time frame: from out of operation room to discharge from the hospital
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TV = 6 ml/kg | Patients With Unplanned ICU Admission | 44 participants |
| TV = 10 ml/kg | Patients With Unplanned ICU Admission | 43 participants |
| PEEP = 5cmH2O | Patients With Unplanned ICU Admission | 43 participants |
| PEEP = 8cmH2O | Patients With Unplanned ICU Admission | 44 participants |