NCT03176589|Completed
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Sponsor study identifier
interventional
80
1 country
1
Study Start
June 12, 2017
Actual (reported)Primary Completion
December 31, 2018
Actual (reported)Study Completion
December 31, 2018
Actual (reported)Positive expiratory pressure( PEP) is routinely given to patients after surgery in order to improve lung function and oxygen saturation. There is, however, no evidence of effect on lung function, postoperative pneumonia or any other outcome (Guimarães MMF, Tyson AF). The investigators aim to test the immediate effects of PEP therapy on oxygen saturation and carbon dioxide after abdominal surgery. 80 patients will be investigated in RCT design with expiration using PEP or with expiration to a sham-PEP, a tube without resistance. At the end of the study we will also measure the effect of 10x3 deep breathing maneuvers without PEP or shamPEP. Primary outcome: Maximum and minimum levels of continuously measured oxygen saturation from pulse oximetry and transcutaneous carbon dioxide partial pressure during the trial.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 24, 2017
Actual (reported)June 5, 2017
Actual (reported)June 12, 2017
Actual (reported)December 31, 2018
Actual (reported)December 31, 2018
Actual (reported)Transcutaneous blood gas measurements: transcutaneous pCO2
transcutaneous pCO2
once, within one hour
Pulse oximetry: oxygen saturation (SaO2)
once, within one hour
Lung function: PEF
once, within one hour
3 cycles of 10 deep inspiration and expiration in a sham tube without expiratory resistance
3 cycles of 10 deep inspiration followed by expiration with positive expiratory pressure (PEP) device or PEP bottle of 10-15 cm of water pressure
3 cycled of 10 deep breathing maneuvers without PEP or sham PEP
Patients take a deep inspiration followed by PEP expiration with an expiratory pressure of 10-15 cm H2O
Deep inspirations 3 times 10 and expiration in a placebo tube without expiratory resistance
Dept of Surgery, Inst of Surgical and Perioperative sciences
Umeå, Umea, 901 85, Sweden
Guimaraes MM, El Dib R, Smith AF, Matos D. Incentive spirometry for prevention of postoperative pulmonary complications in upper abdominal surgery. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD006058. doi: 10.1002/14651858.CD006058.pub2.
Tyson AF, Kendig CE, Mabedi C, Cairns BA, Charles AG. The effect of incentive spirometry on postoperative pulmonary function following laparotomy: a randomized clinical trial. JAMA Surg. 2015 Mar 1;150(3):229-36. doi: 10.1001/jamasurg.2014.1846.
Karl Franklin, Ass Prof
Umea University
80 participants (actual enrollment reported by the registry).
First Submitted
May 24, 2017
First Posted
June 5, 2017
Study Start
Qp/Qs Ratio by Noninvasive Methods in Children With Shunt Dependent Pulmonary Circulation
deep breathing maneuvers 3 times 10 breahs without any device at expiration
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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June 12, 2017
Primary Completion
December 31, 2018
Actual (reported)Study Completion
December 31, 2018
Actual (reported)Last Updated
November 10, 2020
Record last verified: 2020-11
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Source: ClinicalTrials.gov.
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