Effect of Speaking Aloud After Abdominal Surgery.

NCT04276584 | Completed

• 1 other identifier: 201822831
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Respiratory Complications

Keywords

abdominal surgery; hypoxia; lung function; ventilation; Carbon dioxide partial pressure; oxygen situation; Postoperative; Positive expiratory pressure therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Ventilation after speaking aloud

  At day 1 or 2 after surgery

Study Arms (2)

Positive expiratory pressure

ACTIVE COMPARATOR

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

Speaking loudly

EXPERIMENTAL

Speaking loudly during 3 minutes.

Other: Speaking loudly during about 3 minutes

Interventions

Positive expiratory pressure DEVICE

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.

Positive expiratory pressure

Speaking loudly during about 3 minutes OTHER

A specified swedish text

Speaking loudly

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Patients referred to ICU because of immediate postoperative complications.
• Patients who are unable to perform the study.

Sponsors & Collaborators

• Umeå University: lead
• Swedish Heart Lung Foundation: collaborator

Study Sites (1)

Dept of Surgery, Inst of Surgical and Perioperative sciences

Umeå, Umea, 901 85, Sweden

Location

MeSH Terms

Conditions

Hypoxia; Respiratory Aspiration

Interventions

Positive-Pressure Respiration

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Karl A Franklin, MD, Prof

  Dept Surgical and periopertive sciences, Umeå university, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Patients are given a serial number. The randomization orders are blinded to the outcome assessor.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 19, 2020
• Study Start: February 20, 2020
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: January 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: When the study is published and 10 years forward
• 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.

Locations

SE (1)