Effect of Speaking Aloud After Abdominal Surgery.

Effect of Speaking Aloud vs. Positive Expiratory Pressure Therapy on Oxygen Saturation After Abdominal Surgery.

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Respiratory Complications
• Intervention / Treatment: Other: Speaking loudly during about 3 minutes; Device: Positive expiratory pressure

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Umea
    • Umeå, Umea, Sweden, 901 85
      • Dept of Surgery, Inst of Surgical and Perioperative sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Speaking loudly; Speaking loudly during 3 minutes.	Other: Speaking loudly during about 3 minutes; A specified swedish text
Active Comparator: Positive expiratory pressure; Deep inspiration followed by expiration to a resistance of 10-15 cm of water pressure. Done three times, each time with 10 inspiration/expiration cycles	Device: Positive expiratory pressure; Three blocks of 10 deep inspiration followed by expiration against a positive airway pressure device of 10-15 cm of water pressure. Repeated three times. Estimated time of 3 minutes time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen saturation after speaking aloud	Oxygen saturation (SaO2) at 7 minutes after speaking aloud compared with positive expiratory pressure therapy	At day 1 or 2 after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilation after speaking aloud	Transcutaneous carbon dioxide partial pressure after speaking aloud compared with positive expiratory pressure therapy	At day 1 or 2 after surgery

Collaborators and Investigators

• Sponsor: Umeå University
• Collaborators: Swedish Heart Lung Foundation
• Investigators: Principal Investigator: Karl A Franklin, MD, Prof, Dept Surgical and periopertive sciences, Umeå university, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2020
• Primary Completion (Actual): July 31, 2020
• Study Completion (Actual): July 31, 2020

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 17, 2020
• First Posted (Actual): February 19, 2020

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: lung function; ventilation; hypoxia; Postoperative; abdominal surgery; Carbon dioxide partial pressure; oxygen situation; Positive expiratory pressure therapy
• Other Study ID Numbers: 201822831

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: To share all the measured data from each participant.
• IPD Sharing Time Frame: When the study is published and 10 years forward
• IPD Sharing Access Criteria: Deidentified individual participant data will be available to medical researchers by request in accordance with local registration and ethical approval when the article has been published until December 2031. All proposals requesting data access will be reviewed on a case by case basis and will need to specify an analysis plan and will need approval of the scientific board before any data can be released.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No