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
Not provided
The purpose of this study is to evaluate the use of preoperative incentive spirometry (IS) as an aid to improve postoperative lung function. The hypothesis is that application of a standardized protocol of preoperative respiratory care teaching and exercise will improve lung performance that will subsequently result in prevention of postoperative pulmonary complications and that increasing the duration of preoperative use better improves lung mechanics postoperatively. The investigators propose to compare a patient population that uses IS as currently prescribed in the routine course of care (only to be familiar with preoperatively, but use postoperatively) against a population that uses IS with a standardized regimen for at least 3 days prior to the operation in terms of preoperative IS volumes, intraoperative pulmonary mechanics, postoperative IS volumes, and incidence of postoperative pulmonary complications.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | Patients assigned to the control group were educated on the proper technique of using the incentive spirometer and were instructed to use it for 3 breaths once per day to become able to use the device properly and consistently. |
|
| Experimental Group | Experimental | Patients assigned to the experimental group were instructed to use the spirometer by inhaling as slowly and deeply as possible in a set of 10 times and to repeat the process at least 5 times every day until the day of surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Incentive Spirometry | Procedure | helps patient monitor their inspiratory tidal volume and assists in the preventing lower airway collapse |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post Operative Incentive Spirometry Volume | After the operation, the patients to be discharged on the same day were approached in the postanesthesia care unit (PACU) and requested to use the spirometer again. The volume (best out of 2 attempts) was recorded together with the same vital signs recorded preoperatively. Patients who were admitted to the hospital were requested to use the spirometer again on postoperative day 1. The largest IS volume (out of 2 attempts) was recorded. The data presented is the mean largest IS volume the day after surgery. | 1 week before surgery to the day after |
| Measure | Description | Time Frame |
|---|---|---|
| Level of Compliance | 3 days to 2 weeks after clinic visit on the day of surgery | |
| Oxygen Saturation | one week prior to surgery up to one day after | |
| Heart Rate |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Davide Cattano, M.D. | University of Texas Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Hermann Hospital | Houston | Texas | 77030 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Patients assigned to the control group were educated on the proper technique of using the incentive spirometer to familiarize themselves with the device. Subjects were instructed to use it for 3 breaths once per day so that they would able to use the device properly and consistently. All patients in this group used the device at least 3 days prior to their surgical procedure. |
| FG001 | Experimental Group | Patients assigned to the experimental group were instructed to use the incentive spirometer by inhaling as slowly and deeply as possible in a set of 10 times and were asked to repeat the process at least 5 times every day until the day of surgery. All patients in this group used the device at least 3 days prior to their surgical procedure. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Patients assigned to the control group were educated on the proper technique of using the incentive spirometer and were instructed to use it for 3 breaths once per day to become able to use the device properly and consistently. |
| BG001 | Experimental Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Post Operative Incentive Spirometry Volume | After the operation, the patients to be discharged on the same day were approached in the postanesthesia care unit (PACU) and requested to use the spirometer again. The volume (best out of 2 attempts) was recorded together with the same vital signs recorded preoperatively. Patients who were admitted to the hospital were requested to use the spirometer again on postoperative day 1. The largest IS volume (out of 2 attempts) was recorded. The data presented is the mean largest IS volume the day after surgery. | Posted | Mean | Standard Deviation | cc | 1 week before surgery to the day after |
|
Not provided
Not provided
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 | Control Group | Patients assigned to the control group were educated on the proper technique of using the incentive spirometer to familiarize themselves with the device. Subjects were instructed to use it for 3 breaths once per day so that they would able to use the device properly and consistently. All patients in this group used the device at least 3 days prior to their surgical procedure. |
Not provided
Not provided
Our analysis was limited to measuring lung volumes up until postoperative day 1.Extending this study a few days postoperatively likely would allow us to achieve a better understanding of the course of respiratory function recovery.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Davide Cattano | University of Texas at Houston Medical School / Dept. of Anesthesiology | 713-500-6235 | davide.cattano@uth.tmc.edu |
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| one week prior to surgery to post operative day 1 |
| Respiratory Rate | one week prior to surgery to post operative day 1 |
Patients assigned to the experimental group were instructed to use the spirometer by inhaling as slowly and deeply as possible in a set of 10 times and to repeat the process at least 5 times every day until the day of surgery. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Experimental Group | Patients assigned to the experimental group were instructed to use the spirometer by inhaling as slowly and deeply as possible in a set of 10 times and to repeat the process at least 5 times every day until the day of surgery. |
|
|
| Secondary | Level of Compliance | Not Posted | 3 days to 2 weeks after clinic visit on the day of surgery |
| Secondary | Oxygen Saturation | Not Posted | one week prior to surgery up to one day after |
| Secondary | Heart Rate | Not Posted | one week prior to surgery to post operative day 1 |
| Secondary | Respiratory Rate | Not Posted | one week prior to surgery to post operative day 1 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Experimental Group | Patients assigned to the experimental group were instructed to use the incentive spirometer by inhaling as slowly and deeply as possible in a set of 10 times and were asked to repeat the process at least 5 times every day until the day of surgery. All patients in this group used the device at least 3 days prior to their surgical procedure. | 0 | 20 | 0 | 20 |
Not provided
Not provided
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |