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

NCT03176589 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-11-10

No results posted yet for this study

Summary

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.

Conditions

  • Blood Gas Monitoring, Transcutaneous

Interventions

DEVICE

positive expiratory pressure (PEP)

Patients take a deep inspiration followed by PEP expiration with an expiratory pressure of 10-15 cm H2O

DEVICE

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

OTHER

Deep breathing maneuvers

deep breathing maneuvers 3 times 10 breahs without any device at expiration

Sponsors & Collaborators

  • Umeå University

    lead OTHER

Principal Investigators

  • Karl Franklin, Ass Prof · Umea University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-12
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03176589 on ClinicalTrials.gov