Effect of Speaking Aloud After Abdominal Surgery.

Sponsor

Umeå University (Other)

Overall Status

Completed

CT.gov ID

NCT04276584

Collaborator

Swedish Heart Lung Foundation (Other)

Enrollment

Location

Arms

5.3

Actual Duration (Months)

9.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Hypoxia and reduced vital capacity is commonly occurring after abdominal surgery. Positive expiratory pressure (PEP) is one treatment suggested to improve lung function after surgery. We aim to test whether speaking and singing improve postoperative oxygen saturation and ventilation after abdominal surgery. In a cross-over design, 50 subjects will be randomized to start with either PEP maneuvers, i.e. deep inspiration followed by expiration in a positive expiratory pressure device of 10-15 cm H20 or to start with reading a text loudly. The experiment will end with singing a song. Patients will be monitored using Noxturnal T3, Res Med for respiration and pulse oximetry, and online transcutaneous carbon dioxide partial pressure (PtcCO2) measurements (SenTec Digital Monitoing systems). Main outcome measurements include oxygen saturation and PtcPCO2. Arterial blood gases will be taken at study start.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Respiratory Complications	Device: Positive airway pressure (PEP) Other: Speaking loudly during about 3 minutes Other: Singing	N/A

Detailed Description

Hypoxia and reduced vital capacity is commonly occurring after abdominal surgery. Positive expiratory pressure (PEP) 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 and singing improve postoperative oxygen saturation and ventilation after abdominal surgery.

It was estimated that a sample size of 34 patients was needed in a cross sectional study 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 cross-over design, 50 subjects will be randomized (1:1) to start with either PEP 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. The experiment will end with singing a song. 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 (PtcCO2) measurements. Main outcome measurements include oxygen saturation and PtcPCO2.

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

PEP (positive expiratory pressure) is routinely given to patients after abdominal surgery in order to improve postoperative oxygen saturation and lung function. We aim to test whether speaking loudly and singing 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 PEP (10 times 3 inspiration and expiration to positive expiratory pressure) or with speaking loudly from a given text. The study will end with singing a song.PEP (positive expiratory pressure) is routinely given to patients after abdominal surgery in order to improve postoperative oxygen saturation and lung function. We aim to test whether speaking loudly and singing 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 PEP (10 times 3 inspiration and expiration to positive expiratory pressure) or with speaking loudly from a given text. The study will end with singing a song.

Masking:

Single (Outcomes Assessor)

Masking Description:

Patients are given a serial number. The randomization orders are blinded to the outcome assessor.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 20, 2020

Actual Primary Completion Date :

Jul 31, 2020

Actual Study Completion Date :

Jul 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Positive airway pressure (PEP) Deep inspiration followed by expiration to a resistance of 10-15 cm water pressure. Done three times, each time with 10 inspiration/expiration cycles	Device: Positive airway pressure (PEP) 3 blocks of 10 deep inspiration followed by expiration against a positive airway pressure device of 10-15 cm H2O. Repeated three times. Estimated time of 3 minutes time.
Experimental: Speaking loudly Speaking loudly during 3 minutes.	Other: Speaking loudly during about 3 minutes A specified swedish text
Experimental: Singing Singing a Swedish song. The study will end with this song.	Other: Singing Singing a Swedish song

Arm

Intervention/Treatment

Active Comparator: Positive airway pressure (PEP)

Deep inspiration followed by expiration to a resistance of 10-15 cm water pressure. Done three times, each time with 10 inspiration/expiration cycles

Device: Positive airway pressure (PEP)

3 blocks of 10 deep inspiration followed by expiration against a positive airway pressure device of 10-15 cm H2O. Repeated three times. Estimated time of 3 minutes time.

Experimental: Speaking loudly

Speaking loudly during 3 minutes.

Other: Speaking loudly during about 3 minutes

A specified swedish text

Experimental: Singing

Singing a Swedish song. The study will end with this song.

Other: Singing

Singing a Swedish song

Outcome Measures

Primary Outcome Measures

Oxygen saturation [At day 1 or 2 after surgery]
Oxygen saturation(SaO2) measured continuously by finger probe

Secondary Outcome Measures

Ventilation [At day 1 or 2 after surgery]
Continuously measured transcutaneous PCO2

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dept of Surgery, Inst of Surgical and Perioperative sciences	Umeå	Umea	Sweden	901 85

Sponsors and Collaborators

Umeå University
Swedish Heart Lung Foundation

Investigators

Principal Investigator: Karl A Franklin, MD, Prof, Dept Surgical and periopertive sciences, Umeå university, Sweden

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Umeå University

ClinicalTrials.gov Identifier:

NCT04276584

Other Study ID Numbers:

201822831

First Posted:

Feb 19, 2020

Last Update Posted:

Apr 1, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Umeå University

Carbon dioxide partial pressure

oxygen situation

Postoperative

Study Results

No Results Posted as of Apr 1, 2022