NCT06538051

Brief Summary

Aim: The study was carried out to examine the effect of lying positions on hemodynamic parameters in patients with mechanical ventilation (MV) and spontaneous breathing. Material and Methods: The research was carried out semi-experimentally with a single-group posttest design, between November 2021 and May 2022 in the Internal Medicine Intensive Care (ICU) Unit a University Hospital. The study of the sample consisted of 60 patients in the ICU. Data were collected with the patient identification form and the hemodynamic parameters follow-up form. The patients were given different lying positions for 3 days. Hemodynamic parameters were measured and recorded at the 10th minute, 1st hour and 2nd hour after position changes. The measurement results obtained were compared with one-way ANOVA test.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2022

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 5, 2024

Completed
Last Updated

August 5, 2024

Status Verified

June 1, 2024

Enrollment Period

Same day

First QC Date

July 1, 2024

Last Update Submit

July 31, 2024

Conditions

Keywords

Patient positionnurseHemodynamic parameterIntensive care unit

Outcome Measures

Primary Outcomes (4)

  • Respiratory rate

    The patients' respiratory rate were measured and compared separately in the supine semi-fowler's and lateral positions.

    Measurements were made 3 times a day (10th minute, 1st hour and 2nd hour) for 3 days.

  • oxygen saturation

    The patients' oxygen saturation were measured and compared separately in the supine semi-fowler's and lateral positions.

    Measurements were made 3 times a day (10th minute, 1st hour and 2nd hour) for 3 days.

  • Arterial blood pressure

    The patients' arterial blood pressure were measured and compared separately in the supine semi-fowler's and lateral positions.

    Measurements were made 3 times a day (10th minute, 1st hour and 2nd hour) for 3 days.

  • pulse rate

    The patients' pulse rate were measured and compared separately in the supine semi-fowler's and lateral positions.

    Measurements were made 3 times a day (10th minute, 1st hour and 2nd hour) for 3 days.

Study Arms (1)

lying positions

OTHER
Other: lying positions

Interventions

All patients were placed in supine, semi-fowler's and lateral positions, respectively. The effects of positions on hemodynamic parameters were examined.

lying positions

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hospitalized in intensive care for at least 3 days
  • over 18 years of age
  • monitored
  • spontaneously breathing or connected to a mechanical ventilator,
  • conscious or unconscious,
  • receiving or not receiving oxygen support,
  • with or without a tracheostomy,
  • hemoglobin level of 8g/dl.

You may not qualify if:

  • Patients with movement restrictions
  • inotropic/vasopressor and sedative group medications
  • body temperature of 38˚C and above
  • patients receiving CPAP (Continuous Positive Airway Pressure) treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sevil Olğun

Aydin, 09010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Somatosensory Disorders

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adnan Menderes University

Study Record Dates

First Submitted

July 1, 2024

First Posted

August 5, 2024

Study Start

November 15, 2021

Primary Completion

November 15, 2021

Study Completion

May 15, 2022

Last Updated

August 5, 2024

Record last verified: 2024-06

Locations