Clinical trial NCT04276584: Effect of Speaking Aloud After Abdominal Surgery.
Official title: Effect of Speaking Aloud vs. Positive Expiratory Pressure Therapy on Oxygen Saturation After Abdominal Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Respiratory Complications
Keywords: abdominal surgery
hypoxia
lung function
ventilation
Carbon dioxide partial pressure
oxygen situation
Postoperative
Positive expiratory pressure therapy
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Swedish Heart Lung Foundation
First posted: 2020-02-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Positive expiratory pressure is given to patients after abdominal surgery in order to improve postoperative oxygen saturation and lung function. We aim to test whether speaking loudly from a given text improve postoperative oxygen saturation and ventilation. 50 patients will be investigated in a randomized controlled trial with cross-over design starting either with positive expiratory pressure therapy (10 times 3 inspiration and expiration to positive expiratory pressure) or with speaking loudly from a given text.
Primary purpose: TREATMENT

Brief summary: Hypoxia and reduced vital capacity is commonly occurring after abdominal surgery. Positive expiratory pressure is one treatment suggested to improve lung function after surgery. We aim to test whether speaking improves postoperative oxygen saturation and ventilation after abdominal surgery. In a cross-over design, 50 subjects will be randomized to start with either positive expiratory pressure maneuvers, i.e. deep inspiration followed by expiration in a positive expiratory pressure device at 10-15 cm of water, or to start with reading a text loudly. Arterial blood gases will be taken at study start. Patients will be monitored using Noxturnal T3, Res Med for respiration and pulse oximetry, and online transcutaneous carbon dioxide partial pressure measurements (SenTec Digital monitoring systems). Main outcome measurements include oxygen saturation after speaking compared with positive expiratory pressure therapy.

Detailed description: Hypoxia and reduced vital capacity is commonly occurring after abdominal surgery. Positive expiratory pressure is one treatment suggested to improve lung function after surgery, but there is a lack of evidence of effect. En passant, we observed that oxygen saturation was improved when patients talked postoperative day 1. We aim to test whether speaking improves postoperative oxygen saturation and ventilation after abdominal surgery.

It was estimated that a sample size of 34 patients was needed to detect a mean and (SD) difference in oxygen saturation of 1% (2%) and to detect a difference in transcutaneous carbon dioxide partial pressure of 0.5 kPa (1 kPa) with a significance level of 0.05 and a power of 0.8.

In a randomized controlled trial, 50 subjects will be randomized (1:1) to start with either positive expiratory pressure maneuvers, i.e. 3 x 10 deep inspiration followed by expiration in a positive expiratory pressure device of 10-15 cm H20 or to start with reading a text loudly during 3 minutes. Patients will be monitored using Noxturnal T3, Res Med for respiration and pulse oximetry. SenTec Digital Monitoring systems for online transcutaneous carbon dioxide partial pressure measurements.

Eligibility criteria: Inclusion Criteria:

* Performed abdominal surgery within 2 days at the departments of surgery, urology or gynecology at Umeå university hospital

Exclusion Criteria:

* Patients referred to ICU because of immediate postoperative complications.

  * Patients who are unable to perform the study.

Primary outcomes:
measure: Oxygen saturation after speaking aloud
timeFrame: At day 1 or 2 after surgery
Secondary outcomes:
measure: Ventilation after speaking aloud
timeFrame: At day 1 or 2 after surgery
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Dept of Surgery, Inst of Surgical and Perioperative sciences
state: Umea
Study officials:
affiliation: Dept Surgical and periopertive sciences, Umeå university, Sweden
name: Karl A Franklin, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References: