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| Name | Class |
|---|---|
| Swedish Heart Lung Foundation | OTHER |
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Hypoxia and reduced vital capacity is commonly occurring after abdominal surgery. Positive expiratory pressure is one treatment suggested to improve lung function after surgery. We aim to test whether speaking improves postoperative oxygen saturation and ventilation after abdominal surgery. In a cross-over design, 50 subjects will be randomized to start with either positive expiratory pressure maneuvers, i.e. deep inspiration followed by expiration in a positive expiratory pressure device at 10-15 cm of water, or to start with reading a text loudly. Arterial blood gases will be taken at study start. Patients will be monitored using Noxturnal T3, Res Med for respiration and pulse oximetry, and online transcutaneous carbon dioxide partial pressure measurements (SenTec Digital monitoring systems). Main outcome measurements include oxygen saturation after speaking compared with positive expiratory pressure therapy.
Hypoxia and reduced vital capacity is commonly occurring after abdominal surgery. Positive expiratory pressure is one treatment suggested to improve lung function after surgery, but there is a lack of evidence of effect. En passant, we observed that oxygen saturation was improved when patients talked postoperative day 1. We aim to test whether speaking improves postoperative oxygen saturation and ventilation after abdominal surgery.
It was estimated that a sample size of 34 patients was needed to detect a mean and (SD) difference in oxygen saturation of 1% (2%) and to detect a difference in transcutaneous carbon dioxide partial pressure of 0.5 kPa (1 kPa) with a significance level of 0.05 and a power of 0.8.
In a randomized controlled trial, 50 subjects will be randomized (1:1) to start with either positive expiratory pressure maneuvers, i.e. 3 x 10 deep inspiration followed by expiration in a positive expiratory pressure device of 10-15 cm H20 or to start with reading a text loudly during 3 minutes. Patients will be monitored using Noxturnal T3, Res Med for respiration and pulse oximetry. SenTec Digital Monitoring systems for online transcutaneous carbon dioxide partial pressure measurements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive expiratory pressure | Active Comparator | Deep inspiration followed by expiration to a resistance of 10-15 cm of water pressure. Done three times, each time with 10 inspiration/expiration cycles |
|
| Speaking loudly | Experimental | Speaking loudly during 3 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positive expiratory pressure | Device | Three blocks of 10 deep inspiration followed by expiration against a positive airway pressure device of 10-15 cm of water pressure. Repeated three times. Estimated time of 3 minutes time. |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen saturation after speaking aloud | Oxygen saturation (SaO2) at 7 minutes after speaking aloud compared with positive expiratory pressure therapy | At day 1 or 2 after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilation after speaking aloud | Transcutaneous carbon dioxide partial pressure after speaking aloud compared with positive expiratory pressure therapy | At day 1 or 2 after surgery |
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Inclusion Criteria:
Exclusion Criteria:
Patients referred to ICU because of immediate postoperative complications.
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| Name | Affiliation | Role |
|---|---|---|
| Karl A Franklin, MD, Prof | Dept Surgical and periopertive sciences, Umeå university, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept of Surgery, Inst of Surgical and Perioperative sciences | Umeå | Umea | 901 85 | Sweden |
To share all the measured data from each participant.
When the study is published and 10 years forward
Deidentified individual participant data will be available to medical researchers by request in accordance with local registration and ethical approval when the article has been published until December 2031. All proposals requesting data access will be reviewed on a case by case basis and will need to specify an analysis plan and will need approval of the scientific board before any data can be released.
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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Positive expiratory pressure is given to patients after abdominal surgery in order to improve postoperative oxygen saturation and lung function. We aim to test whether speaking loudly from a given text improve postoperative oxygen saturation and ventilation. 50 patients will be investigated in a randomized controlled trial with cross-over design starting either with positive expiratory pressure therapy (10 times 3 inspiration and expiration to positive expiratory pressure) or with speaking loudly from a given text.
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Patients are given a serial number. The randomization orders are blinded to the outcome assessor.
| Speaking loudly during about 3 minutes | Other | A specified swedish text |
|
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |