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Effect of PEP on Oxygen Saturation and Carbon Dioxide After Abdominal Surgery

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ClinicalTrials.gov Identifier: NCT03176589
Recruitment Status : Completed
First Posted : June 5, 2017
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
Karl A Franklin, Umeå University

Brief Summary:
PEP (positive expiratory pressure) is routinely given to patients after surgery in order to improve lung function. 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 on oxygen saturation and carbon dioxide. 80 patients will be investigated in RCT design with deep inspirations and expiration using PEP or only deep inspiration with expiration a placebo tube without resistance air. At the end of the study we will also measure the effect of 10x3 very deep inspirations and no expiratory no expiratory resistance. Primary outcome: continuous oxygen saturation from pulse oximetry and transcutaneous carbon dioxide.

Condition or disease Intervention/treatment Phase
Blood Gas Monitoring, Transcutaneous Device: positive expiratory pressure (PEP) Other: Placebo comparator, Deep inspiration and expression in a placebo tube without resistance Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: PEP
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: tube without resistance
Primary Purpose: Treatment
Official Title: Effect of PEP on Oxygen Saturation and Carbon Dioxide After Abdominal Surgery
Actual Study Start Date : June 12, 2017
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Placebo Comparator: placebo
3 cycles of 10 deep inspiration and expiration in a placebo tube without expiratory resistance
Other: Placebo comparator, Deep inspiration and expression in a placebo tube without resistance
Deep inspirations 3 times 10 and expiration in a placebo tube without expiratory resistance

Active Comparator: PEP
3 cycles of 10 deep inspiration followed by expiration with positive expiratory pressure (PEP)
Device: positive expiratory pressure (PEP)
Patients take a deep inspiration followed by PEP expiration with an expiratory pressure of 10-15 cm H2O




Primary Outcome Measures :
  1. Transcutaneous blood gas measurements: transcutaneous pCO2 [ Time Frame: once, within one hour ]
    transcutaneous pCO2


Secondary Outcome Measures :
  1. Pulse oximetry: oxygen saturation (SaO2) [ Time Frame: once, within one hour ]
    oxygen saturation (SaO2)

  2. Lung function: PEF [ Time Frame: once, within one hour ]
    Peak expiratory flow



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients over 18 years of age who have undergone open or laparoscopic abdominal surgery.
  • Patients receiving postoperative PEP are asked the day after surgery if they want to participate in the study.

Exclusion Criteria:

  • Patients who cannot participate in using PEP or who do not agree to participate in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03176589


Locations
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Sweden
Dept of Surgery, Inst of Surgical and Perioperative sciences
Umeå, Umea, Sweden, 901 85
Sponsors and Collaborators
Umeå University
Investigators
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Principal Investigator: Karl Franklin, Ass Prof Umea University

Publications:
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Responsible Party: Karl A Franklin, Ass Prof, Umeå University
ClinicalTrials.gov Identifier: NCT03176589     History of Changes
Other Study ID Numbers: 2017/195-31
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Karl A Franklin, Umeå University:
positive expiratory pressure
oxygen saturation
abdominal surgery
carbon dioxide