Clinical trial NCT05683743: The Incidence, Risk Factors, and Effects of Constipation in Critical Patients
Official title: The Incidence, Risk Factors, and Effects of Constipation in Critical Patients: An Observational Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Constipation
Keywords: Critical care
Constipation
Intensive care
Nursing
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2023-01-13
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The data were collected from the Anesthesia and Reanimation Intensive Care Unit in a state hospital of Bolu in 2019. To determine the number of observations in our study, a pilot study was conducted with 20 patients. These patients were also included in the main study. The constipation rate in the intensive care unit was determined as 67% in the pilot study. Considering this ratio, the sample size was calculated using the PASS 11 program. Accordingly, at least 86 patients had to be included in the study keeping a 95% probability and 10% deviation. The sample consisted of 116 patients who were reachable during the study, met the inclusion criteria, and volunteered to participate in the study.

Brief summary: This study aimed to investigate the early, late, and total constipation frequency, related factors, and their effects on the hospitalization day, gastric residual volume, vomiting, distension, and diarrhea, the feeding type, white blood cells, and C-Reactive Protein levels, and body temperature.

Detailed description: Constipation is one of the most encountered nursing problems in intensive care unit patients.

Constipation is an important issue, especially in intensive care patients, requiring careful discussion since it has negative effects as well as high incidence and excessive risk factors. Furthermore, untreated constipation in these patients delays enteral feeding prolonging the time of weaning from the mechanical ventilator, which consequently increases the duration of stay in the intensive care unit. Additionally, it involves complications such as distention, nausea-vomiting, an increase in bacterial infection rate, high morbidity, and mortality. Therefore, the definitions, risks, and effects of constipation, especially early and late constipation, in critically ill patients should be determined for evidence-based interventions. However, studies on the subject are limited.

Eligibility criteria: Inclusion Criteria:

* \>18 years
* Not abdominal surgery
* Not stoma
* Not constipation during admission
* Not intraperitoneal infection
* Not had a recent colonoscopy -\> 5 hospitalization days

Exclusion Criteria:

* Having prolonged constipation and complications (such as decreased bowel sounds, and excessive distension)
* Order for regular laxatives or enemas
* Not meet inclusion criteria during follow-up

Primary outcomes:
measure: The frequency of total constipation, early-type constipation and late-type constipation
timeFrame: Through study completion, an average of five months
Secondary outcomes:
measure: he duration of stay in the intensive care unit
timeFrame: Through study completion, an average of five months
measure: the amount of gastric residual volume
timeFrame: Through study completion, an avarage of five months
measure: developing vomiting
timeFrame: Through study completion, an average of five months
measure: Level of white blood cells
timeFrame: Through study completion, an average of five months
measure: body temperature
timeFrame: Through study completion, an average of five months
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Bolu Izzet Baysal State Hospital, Anesthesia Intensive Care Unit
state: Merkez
Study officials:
affiliation: Bolu Izzet Baysal University
name: Arzu AKMAN YILMAZ, RN, PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Pursaklar State Hospital
name: Seyma OZDEMIR, RN,MSN.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bolu Izzet Baysal State Hospital
name: Esra OZDEMIR, MD.
role: PRINCIPAL_INVESTIGATOR
References: