Ventilation Strategies, Anesthetic Techniques and Cerebral Oxygenation in the Beach Chair Position
Sponsor
University of Michigan (Other)
Overall Status
Completed
CT.gov ID
NCT01535274
Collaborator
(none)
67
1
2
24
2.8
Study Details
Study Description
Brief Summary
The seated or "beach chair" position during surgery and general anesthesia decreases brain oxygen levels and can result in stroke. As such, poor neurological outcome following beach chair positioning is a growing concern. In the proposed study the investigators test the hypothesis that changes in ventilation strategy and anesthetic technique can affect cerebral oxygenation in anesthetized patients in the beach chair position.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This is a prospective cohort study with randomized nested design. Patients presenting for shoulder surgery will be randomized to receive desflurane or total intravenous anesthesia with propofol. Regional cerebral oxygenation will be measured using the INVOS 5100C monitor (Covidien, Boulder, CO). Depth of anesthesia will be maintained within a Bispectral Index range of 40-60. Following positioning, inspired oxygen fraction and minute ventilation will be sequentially adjusted. At each set point, regional cerebral oxygenation will be recorded and venous blood gas analysis performed. Statistical analysis will be repeated measures analysis of variance in which ventilation strategy is the within-subjects factor and anesthetic technique is the between-subjects factor; post hoc Tukey's correction will be used for multiple comparisons. If simple maneuvers of ventilation and anesthetic technique can prevent low brain oxygen levels, patient outcome may be improved.
Study Design
Study Type:
Interventional
Actual Enrollment
:
67 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Influence of Basic Ventilation Strategies and Anesthetic Techniques on Cerebral Oxygenation in the Beach Chair Position
Study Start Date
:
Sep 1, 2012
Actual Primary Completion Date
:
Sep 1, 2014
Actual Study Completion Date
:
Sep 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Desflurane Patients will receive general anesthesia with desflurane. Both arms have rSO2 measured and undergo identical changes in ventilation strategy. |
Other: Inspired oxygen fraction / end tidal carbon dioxide
Following induction of anesthesia, FIO2 and minute ventilation will be sequentially adjusted to achieve:
FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position.
FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.
FIO2 100%, PETCO2 30mmHg - beach chair position.
FIO2 100%, PETCO2 45mmHg - beach chair position.
FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.
|
| Experimental: Propofol Patients will receive total intravenous general anesthesia (TIVA) with propofol. Both have rSO2 measured and undergo identical changes in ventilation strategy. |
Other: Inspired oxygen fraction / end tidal carbon dioxide
Following induction of anesthesia, FIO2 and minute ventilation will be sequentially adjusted to achieve:
FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position.
FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.
FIO2 100%, PETCO2 30mmHg - beach chair position.
FIO2 100%, PETCO2 45mmHg - beach chair position.
FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.
|
Outcome Measures
Primary Outcome Measures
- Change in Regional Cerebral Oxygenation (rSO2) Before and 5 Minutes After Each Change in Ventilation Strategy [duration of surgery, generally no more than 90 minutes total]
rSO2 will be recorded as a "snap shot." A mean value from right and left sides will be calculated for each patient at each study point. Set Point 1: FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position. Set Point 2: FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position. Set Point 3: FIO2 100%, PETCO2 30mmHg - beach chair position. Set Point 4: FIO2 100%, PETCO2 45mmHg - beach chair position. Set Point 5: FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position. With each set point, the value shown is the absolute change from baseline.
- Regional Cerebral Oxygenation (rSO2) Values [duration of surgery, generally no more than 90 minutes total]
Regional cerebral oxygenation (rSO2) values at the set ventilatory points of the study for each anesthetic choice. Set Point 1: FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position. Set Point 2: FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position. Set Point 3: FIO2 100%, PETCO2 30mmHg - beach chair position. Set Point 4: FIO2 100%, PETCO2 45mmHg - beach chair position. Set Point 5: FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- scheduled for elective arthroscopic shoulder surgery in the beach chair position under general anesthesia with supplemental interscalene block
Exclusion Criteria:
-
refusal to give consent
-
ineligible for interscalene block
-
history of cardiovascular disease
-
history of cerebrovascular disease
-
hypertension
-
respiratory failure
-
non-English speaker
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
Sponsors and Collaborators
- University of Michigan
Investigators
- Principal Investigator: Paul Picton, MD, University of Michigan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Paul Picton,
Assistant Professor,
University of Michigan
ClinicalTrials.gov Identifier:
NCT01535274
Other Study ID Numbers:
- HUM00049747
First Posted:
Feb 17, 2012
Last Update Posted:
Apr 6, 2022
Last Verified:
Apr 1, 2022
Keywords provided by Paul Picton,
Assistant Professor,
University of Michigan
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Ten potential participants were excluded for not meeting inclusion criteria, declination to participate, and other reasons. |
| Arm/Group Title | Propofol | Desflurane |
|---|---|---|
| Arm/Group Description | Patients received total intravenous general anesthesia (TIVA) with propofol. Both have rSO2 measured and undergo identical changes in ventilation strategy. Inspired oxygen fraction / end tidal carbon dioxide: Following induction of anesthesia, FIO2 and minute ventilation was sequentially adjusted to achieve: FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position. FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position. FIO2 100%, PETCO2 30mmHg - beach chair position. FIO2 100%, PETCO2 45mmHg - beach chair position. FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position. | Patients received general anesthesia with desflurane. Both arms have rSO2 measured and undergo identical changes in ventilation strategy. Inspired oxygen fraction / end tidal carbon dioxide: Following induction of anesthesia, FIO2 and minute ventilation was sequentially adjusted to achieve: FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position. FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position. FIO2 100%, PETCO2 30mmHg - beach chair position. FIO2 100%, PETCO2 45mmHg - beach chair position. FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position. |
| Period Title: Overall Study | ||
| STARTED | 28 | 29 |
| Received Propofol | 28 | 1 |
| Received Desflurane | 0 | 28 |
| COMPLETED | 28 | 27 |
| NOT COMPLETED | 0 | 2 |
Baseline Characteristics
| Arm/Group Title | Propofol | Desflurane | Total |
|---|---|---|---|
| Arm/Group Description | Patients received total intravenous general anesthesia (TIVA) with propofol. Both have rSO2 measured and undergo identical changes in ventilation strategy. Inspired oxygen fraction / end tidal carbon dioxide: Following induction of anesthesia, FIO2 and minute ventilation was sequentially adjusted to achieve: FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position. FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position. FIO2 100%, PETCO2 30mmHg - beach chair position. FIO2 100%, PETCO2 45mmHg - beach chair position. FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position. | Patients received general anesthesia with desflurane. Both arms have rSO2 measured and undergo identical changes in ventilation strategy. Inspired oxygen fraction / end tidal carbon dioxide: Following induction of anesthesia, FIO2 and minute ventilation was sequentially adjusted to achieve: FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position. FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position. FIO2 100%, PETCO2 30mmHg - beach chair position. FIO2 100%, PETCO2 45mmHg - beach chair position. FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position. | Total of all reporting groups |
| Overall Participants | 29 | 27 | 56 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
51.3
(10.0)
|
49.3
(13.3)
|
50.34
(11.6)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
11
37.9%
|
10
37%
|
21
37.5%
|
| Male |
18
62.1%
|
17
63%
|
35
62.5%
|
| Region of Enrollment (Count of Participants) | |||
| United States |
29
100%
|
27
100%
|
56
100%
|
Outcome Measures
| Title | Change in Regional Cerebral Oxygenation (rSO2) Before and 5 Minutes After Each Change in Ventilation Strategy |
|---|---|
| Description | rSO2 will be recorded as a "snap shot." A mean value from right and left sides will be calculated for each patient at each study point. Set Point 1: FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position. Set Point 2: FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position. Set Point 3: FIO2 100%, PETCO2 30mmHg - beach chair position. Set Point 4: FIO2 100%, PETCO2 45mmHg - beach chair position. Set Point 5: FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position. With each set point, the value shown is the absolute change from baseline. |
| Time Frame | duration of surgery, generally no more than 90 minutes total |
Outcome Measure Data
| Analysis Population Description |
|---|
| Of the 29 participants initially randomized to receive desflurane treatment, one participant initially randomized to the desflurane arm was misallocated to the propofol arm and received propofol treatment, so is included in the propofol arm here. |
| Arm/Group Title | Propofol | Desflurane |
|---|---|---|
| Arm/Group Description | Patients received total intravenous general anesthesia (TIVA) with propofol. Both have rSO2 measured and undergo identical changes in ventilation strategy. Inspired oxygen fraction / end tidal carbon dioxide: Following induction of anesthesia, FIO2 and minute ventilation was sequentially adjusted to achieve: FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position. FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position. FIO2 100%, PETCO2 30mmHg - beach chair position. FIO2 100%, PETCO2 45mmHg - beach chair position. FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position. | Patients received general anesthesia with desflurane. Both arms have rSO2 measured and undergo identical changes in ventilation strategy. Inspired oxygen fraction / end tidal carbon dioxide: Following induction of anesthesia, FIO2 and minute ventilation was sequentially adjusted to achieve: FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position. FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position. FIO2 100%, PETCO2 30mmHg - beach chair position. FIO2 100%, PETCO2 45mmHg - beach chair position. FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position. |
| Measure Participants | 29 | 27 |
| Set Point 1: FIO2 30%; PETCO2 30mmHg (Supine) |
-4.27
(8.43)
|
-0.70
(10.08)
|
| Set Point 2: FIO2 30%; PETCO2 30mmHg (Beach Chair) |
-15.48
(11.35)
|
-10.90
(7.03)
|
| Set Point 3: FIO2 100%; PETCO2 30mmHg (Beach Chair) |
-8.31
(11.21)
|
-3.14
(7.21)
|
| Set Point 4: FIO2 100%; PETCO2 45mmHg (Beach Chair) |
5.46
(9.79)
|
9.20
(7.01)
|
| Set Point 5: FIO2 30%; PETCO2 30mmHg (Beach Chair) |
-9.00
(11.02)
|
-3.59
(7.67)
|
| Title | Regional Cerebral Oxygenation (rSO2) Values |
|---|---|
| Description | Regional cerebral oxygenation (rSO2) values at the set ventilatory points of the study for each anesthetic choice. Set Point 1: FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position. Set Point 2: FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position. Set Point 3: FIO2 100%, PETCO2 30mmHg - beach chair position. Set Point 4: FIO2 100%, PETCO2 45mmHg - beach chair position. Set Point 5: FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position. |
| Time Frame | duration of surgery, generally no more than 90 minutes total |
Outcome Measure Data
| Analysis Population Description |
|---|
| Of the 29 participants initially randomized to receive desflurane treatment, one participant initially randomized to the desflurane arm was misallocated to the propofol arm and received propofol treatment, so is included in the propofol arm here. |
| Arm/Group Title | Propofol | Desflurane |
|---|---|---|
| Arm/Group Description | Patients will receive total intravenous general anesthesia (TIVA) with propofol. Both have rSO2 measured and undergo identical changes in ventilation strategy. Inspired oxygen fraction / end tidal carbon dioxide: Following induction of anesthesia, FIO2 and minute ventilation will be sequentially adjusted to achieve: FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position. FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position. FIO2 100%, PETCO2 30mmHg - beach chair position. FIO2 100%, PETCO2 45mmHg - beach chair position. FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position. | Patients will receive general anesthesia with desflurane. Both arms have rSO2 measured and undergo identical changes in ventilation strategy. Inspired oxygen fraction / end tidal carbon dioxide: Following induction of anesthesia, FIO2 and minute ventilation will be sequentially adjusted to achieve: FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position. FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position. FIO2 100%, PETCO2 30mmHg - beach chair position. FIO2 100%, PETCO2 45mmHg - beach chair position. FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position. |
| Measure Participants | 29 | 27 |
| Set Point 1: Fio2 0.3 Petco2 30 mmHg |
67
(13)
|
69
(11)
|
| Set Point 2: Fio2 0.3 Petco2 30 mmHg |
59
(13)
|
62
(10)
|
| Set Point 3: Fio2 1.0 Petco2 30 mmHg |
64
(14)
|
67
(11)
|
| Set Point 4: Fio2 1.0 Petco2 45 mmHg |
74
(12)
|
76
(11)
|
| Set Point 5: Fio2 0.3 Petco2 30 mmHg |
64
(14)
|
67
(12)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Propofol, Desflurane |
|---|---|---|
| Comments | P-values represent comparison of successive set points within anesthetic type (i.e.: Set Point 1 compared to Set Point 2, Set Point 2 compared to Set Point 3, etc.). This P-value was determined for each of set points 1, 2, 3, 4, and 5. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Adverse Events
| Time Frame | During the time of surgery - not more than 90 minutes | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Study team used a non-systematic approach for collecting adverse event information, reliant on patient self-reporting and study team observation during treatment. | |||
| Arm/Group Title | Propofol | Desflurane | ||
| Arm/Group Description | Patients received total intravenous general anesthesia (TIVA) with propofol. Both have rSO2 measured and undergo identical changes in ventilation strategy. Inspired oxygen fraction / end tidal carbon dioxide: Following induction of anesthesia, FIO2 and minute ventilation was sequentially adjusted to achieve: FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position. FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position. FIO2 100%, PETCO2 30mmHg - beach chair position. FIO2 100%, PETCO2 45mmHg - beach chair position. FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position. | Patients received general anesthesia with desflurane. Both arms have rSO2 measured and undergo identical changes in ventilation strategy. Inspired oxygen fraction / end tidal carbon dioxide: Following induction of anesthesia, FIO2 and minute ventilation was sequentially adjusted to achieve: FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position. FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position. FIO2 100%, PETCO2 30mmHg - beach chair position. FIO2 100%, PETCO2 45mmHg - beach chair position. FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position. | ||
All Cause Mortality |
||||
| Propofol | Desflurane | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/29 (0%) | 0/27 (0%) | ||
Serious Adverse Events |
||||
| Propofol | Desflurane | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/29 (0%) | 0/27 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Propofol | Desflurane | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/29 (0%) | 0/27 (0%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Paul Picton |
|---|---|
| Organization | University of Michigan |
| Phone | 734-936-4280 |
| ppicton@umich.edu |
Responsible Party:
Paul Picton,
Assistant Professor,
University of Michigan
ClinicalTrials.gov Identifier:
NCT01535274
Other Study ID Numbers:
- HUM00049747
First Posted:
Feb 17, 2012
Last Update Posted:
Apr 6, 2022
Last Verified:
Apr 1, 2022