Diaphragm Dysfunction and Ultrasound Perioperatively

NCT05906030 | Recruiting

• 1 other identifier: K2023-3473
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims at determining whether diaphragm ultrasound examining diaphragm thickening fraction, excursion and density before and after surgery can predict respiratory complications in the postoperative period. Patients scheduled for major elective abdominal, pelvic or vascular surgery will be included in the study and diaphragm ultrasound is performed before surgery and after surgery in the postoperative ward. Physiological parameters, laboratory parameters, data on surgery and anesthesia and comorbidities will be registered. Complications such as pneumonia, desaturation, need for intubation and other respiratory events up to 30 days will be registered and later correlated with the diaphragm measurements.

Conditions

Respiratory Insufficiency; Pneumonia; Desaturation of Blood; Tachypnea; Atelectasis, Postoperative

Keywords

Diaphragm dysfunction; Postoperative complication; Respiratory complication; Pneumonia; Respiratory insufficiency

Outcome Measures

Primary Outcomes (3)

• Pneumonia

  30 days

• Respiratory insufficiency

  Need for non-invasive or invasive ventilation

  30 days

• Desaturation

  Need for supplemental oxygen

  30 days

Interventions

Diaphragm ultrasound DIAGNOSTIC_TEST

Diaphragm ultrasound will be used pre- and postoperatively. Diaphragm dysfunction will be diagnosed using the measurements diaphragm thickening fraction, diaphragm excursion and diaphragm density.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults undergoing elective (study 1) or acute (study 2) abdominal, pelvic or vascular surgery

You may qualify if:

• Adults undergoing elective (study 1) or acute (study 2) abdominal, pelvic or vascular surgery

You may not qualify if:

• \<18 years
• Underlying chronic respiratory disease
• Patients not able to give informed consent

Sponsors & Collaborators

• Karolinska University Hospital: lead
• Karolinska Institutet: collaborator

Study Sites (2)

Karolinska University Hospital, Perioperative Medicine and Intensive Care

Stockholm, Stockholm County, 17176, Sweden

RECRUITING

Karolinska University Hospital

Stockholm, 17176, Sweden

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency; Pneumonia; Tachypnea; Pulmonary Atelectasis; Postoperative Complications

Condition Hierarchy (Ancestors)

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

Study Officials

• Jessica Kåhlin

  Karolinska Universitetssjukhuset Solna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Kåhlin, MD, PhD

CONTACT

0707295456; jessica.kahlin@regionstockholm.se

Emma Larsson, MD, PhD

CONTACT

0733661661; emma.ca.larsson@regionstockholm.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, PhD

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: June 15, 2023
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)