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| Name | Class |
|---|---|
| Royal University Hospital Foundation | OTHER |
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The purpose of this study is to determine whether prophylactic nasal continuous positive airway pressure (nCPAP) in the post-anaesthesia care unit (PACU) improves post-operative pulmonary function following elective bowel surgery. The investigators hypothesize that one hour of nCPAP in the PACU will result in a higher partial pressure of arterial oxygen (PaO2) when compared to the standard treatment of low flow oxygen applied by face mask.
Post-operative pulmonary complications, such as hypoxemia, pneumonia and respiratory failure, occur in 5-10% of patients following abdominal surgery. These post-operative pulmonary complications result in increased morbidity, mortality, ICU admission, length of hospital stay and resource use.
CPAP has shown to be an effective treatment for hypoxemia following abdominal surgery. It decreases atelectasis formation the risk of pneumonia. Application of nCPAP to treat hypoxemic respiratory failure following thoraco-abdominal surgery has shown to decrease endotracheal intubation.
Nasal CPAP has shown to be effective prophylaxis following elective cardiac and thoraco-abdominal aortic surgery. It reduces the incidence of hypoxemia, pneumonia, re-intubation and re-admission to the ICU. It has also shown to decrease the length of hospital stay.
The use of nCPAP immediately post-operatively in the PACU following abdominal surgery has not been evaluated. Nasal CPAP is better tolerated than full face mask CPAP. It allows for effective clearance of respiratory secretions, improved communication and decreases claustrophobic sensation. The PACU is a transition period from general anaesthesia into the post-operative recovery phase. During this time, residual anaesthetic causes decreased level of consciousness and sub-optimal respiratory effort. Reversal agent for neuromuscular blockade has often not reached its peak effect. Inadequate pain control may further decrease respiratory effort. This transition period may be when maximal atelectasis of alveolar lung units occurs. This time period may be optimal for the application of nCPAP for prophylaxis against hypoxemia. It may improve post-operative pulmonary function which could decrease post-operative morbidity, mortality, length of hospital stay and resource use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nCPAP | Experimental | The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit. |
|
| Low Flow Oxygen | Active Comparator | The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nCPAP | Device | The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Alveolar - Arterial Gradient | The alveolar - arterial gradient is the difference between the partial pressure of alveolar oxygen and the partial pressure of arterial oxygen | 1 hour following admission to PACU |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Requiring Reintubation | Up to 2 weeks | |
| Number of Participants Requiring Admission to ICU | Up to 2 weeks | |
| Length of Stay in Hospital |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William P McKay, MD | Professor | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19017864 | Background | Zarbock A, Mueller E, Netzer S, Gabriel A, Feindt P, Kindgen-Milles D. Prophylactic nasal continuous positive airway pressure following cardiac surgery protects from postoperative pulmonary complications: a prospective, randomized, controlled trial in 500 patients. Chest. 2009 May;135(5):1252-1259. doi: 10.1378/chest.08-1602. Epub 2008 Nov 18. | |
| 18362624 |
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Recruitment began 4 April 2011 and ended 29 April 2012. The target enrollment was 40. 40 patients were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | nCPAP | The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit. |
| FG001 | Low Flow Oxygen | The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | nCPAP | The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit. |
| BG001 | Low Flow Oxygen | The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute. |
| 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 | Alveolar - Arterial Gradient | The alveolar - arterial gradient is the difference between the partial pressure of alveolar oxygen and the partial pressure of arterial oxygen | From the literature, a sample size of 19 subjects per group is required for a power >0.9 and alpha <0.05 assuming a normalised difference in A-a gradient between groups of 0.33 and a Standard Deviation (SD) of 0.33 | Posted | Mean | Standard Deviation | torr | 1 hour following admission to PACU |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | nCPAP | 0 | 18 |
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We made an assumption for FiO2, the respiratory quotient and barometric pressure in the alveolar air equation.
We did not standardize the time between extubation and application of nCPAP.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. William McKay | University of Saskatchewan | 306-655-1202 | william.mckay@saskatoonhealthregion.ca |
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| ID | Term |
|---|---|
| D001261 | Pulmonary Atelectasis |
| D011183 | Postoperative Complications |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Low Flow Oxygen | Device | The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute. |
|
| Up to 2 weeks |
| Ferreyra GP, Baussano I, Squadrone V, Richiardi L, Marchiaro G, Del Sorbo L, Mascia L, Merletti F, Ranieri VM. Continuous positive airway pressure for treatment of respiratory complications after abdominal surgery: a systematic review and meta-analysis. Ann Surg. 2008 Apr;247(4):617-26. doi: 10.1097/SLA.0b013e3181675829. |
| 16100174 | Background | Kindgen-Milles D, Muller E, Buhl R, Bohner H, Ritter D, Sandmann W, Tarnow J. Nasal-continuous positive airway pressure reduces pulmonary morbidity and length of hospital stay following thoracoabdominal aortic surgery. Chest. 2005 Aug;128(2):821-8. doi: 10.1378/chest.128.2.821. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Number of Participants Requiring Reintubation | Posted | Number | participants | Up to 2 weeks |
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| Secondary | Number of Participants Requiring Admission to ICU | Posted | Number | participants | Up to 2 weeks |
|
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| Secondary | Length of Stay in Hospital | Posted | Mean | Standard Deviation | days | Up to 2 weeks |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Low Flow Oxygen | 0 | 19 | 0 | 19 | 0 | 19 |
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| D012120 | Respiration Disorders |