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

NCT03176589 | Completed

• 1 other identifier: 2017/195-31
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

positive expiratory pressure; oxygen saturation; abdominal surgery; carbon dioxide

Outcome Measures

Primary Outcomes (1)

• Transcutaneous blood gas measurements: transcutaneous pCO2

  transcutaneous pCO2

  once, within one hour

Secondary Outcomes (2)

• Pulse oximetry: oxygen saturation (SaO2)

  once, within one hour

• Lung function: PEF

  once, within one hour

Study Arms (3)

sham PEP

SHAM COMPARATOR

3 cycles of 10 deep inspiration and expiration in a sham tube without expiratory resistance

Device: Placebo comparator, Deep inspiration and expression in a placebo tube without resistance

PEP

ACTIVE COMPARATOR

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

Device: positive expiratory pressure (PEP)

deep breathing maneuvers

EXPERIMENTAL

3 cycled of 10 deep breathing maneuvers without PEP or sham PEP

Other: Deep breathing maneuvers

Interventions

positive expiratory pressure (PEP) DEVICE

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

PEP

Placebo comparator, Deep inspiration and expression in a placebo tube without resistance DEVICE

Deep inspirations 3 times 10 and expiration in a placebo tube without expiratory resistance

sham PEP

Deep breathing maneuvers OTHER

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

deep breathing maneuvers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Umeå University: lead

Study Sites (1)

Dept of Surgery, Inst of Surgical and Perioperative sciences

Umeå, Umea, 901 85, Sweden

Location

Related Publications (2)

• 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.

  PMID: 19588380 BACKGROUND

• 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.

  PMID: 25607594 BACKGROUND

MeSH Terms

Interventions

Positive-Pressure Respiration

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Karl Franklin, Ass Prof

  Umea University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: tube without resistance is given to patients. Randomization order is given after the analysis.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass Prof

Model Details: Positive expiratory pressure (PEP) therapy

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: June 5, 2017
• Study Start: June 12, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: November 10, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)