Effect of Speaking Aloud After Abdominal Surgery.

Postoperative Respiratory Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04276584
• Other study ID #: 201822831
• Status: Completed
• Phase: N/A
• Start date: February 20, 2020
• Est. completion date: July 31, 2020

Study information

• Verified date: January 2024
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Postoperative Respiratory Complications

Intervention

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.

Other:
• Speaking loudly during about 3 minutes
A specified swedish text

Locations

Country	Name	City	State
Sweden	Dept of Surgery, Inst of Surgical and Perioperative sciences	Umeå	Umea

Sponsors (2)

Lead Sponsor	Collaborator
Umeå University	Swedish Heart Lung Foundation

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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