The Use of Integrated Pulmonary Index During Cesarean Section Under Spinal Anesthesia

NCT05237856 | Unknown

• 1 other identifier: IPI
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

Postspinal hypotension (PSH) is a common side effect with an incidence of 15.3 to 33% that can result in organ hypoperfusion and ischemic events. In pregnant patients, this incidence may increase to 70% and severe PSH increases the risk of maternal and fetal complications. Therefore, it is extremely important for anesthesiologists to recognize PSH early and treat it quickly during cesarean sections. Integrated pulmonary index (IPI) is an algorithm that has been used recently. IPI takes into account four parameters: respiratory rate, end tidal CO2, heart rate and O2 saturation. Capnography device measuring IPI can continuously monitor and display the patient's respiratory status in a single digit range from 1-10. This index value can be observed continuously on the monitor as digital data or as a waveform. "10" indicates a normal respiratory condition, while "1" indicates that the patient requires immediate intervention. The relationship between values and the patient status is evaluated as follows; 10 = Normal, 8-9 = Normal range, 7 = Near normal range; Requires attention, 5-6 = Requires attention and may require intervention, 3-4 = Requires intervention, 1-2 = Requires immediate intervention. IPI monitorization is mostly used during sedation (gastroscopy, cardioversion), intensive care units (for adjusting mechanical ventilator settings, monitoring the weaning process). As a result, IPI monitoring has attracted attention because it allows non-invasive, dynamic and real-time measurement, reflects respiratory status with high specificity and sensitivity, and enables respiratory problems to be detected earlier. End tidal CO2, which is one of the 4 parameters that IPI value takes into account, is a parameter that can be used to evaluate the effectiveness of ventilation, but is also related to cardiac output (CO) because the delivery of CO2 to the pulmonary system depends on it. Studies have shown that ETCO2 value correlatively decreases when CO decrease, in cases such as hypotension and hypovolemia. We think that ETCO2 will decrease due to pulmonary hypoperfusion in post spinal hypotension and it may cause a change in IPI value. In our study, we will monitor patients who are scheduled for cesarean section under spinal anesthesia with a capnometry device and we will try to determine the significance of IPI monitorization in predicting hypotension.

Conditions

Intraoperative Hypotension

Keywords

cesarean, hypotension, ETCO2, integrated pulmonary index

Outcome Measures

Primary Outcomes (3)

• noninvasive blood pressure

  hypotension:20% reduction in basal blood pressure measurement,

  20 minutes

• Integrated pulmoner index (IPI)

  requires intervention: IPI value \< 7,

  20 minutes

• end-tidal carbon dioxide (ETCO2)

  hypoperfusion: ETCO2 value \< 35 mmHg

  20 minutes

Interventions

Capnometry Monitorization DEVICE

After spinal anesthesia, a non-invasive nasal cannula will be applied to the patient, ETCO2 and IPI values will be continuously measured and recorded from this cannula with a capnometry device.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnants above the age of 18 who will undergo cesarean section under spinal anesthesia

You may qualify if:

• ASA I-II pregnants who will undergo cesarean section under spinal anesthesia

You may not qualify if:

• ASA III- IV Pregnants.
• Pregnants with chronic respiratory disorder.
• Pregnants who will undergo cesarean section under emergency conditions.

Sponsors & Collaborators

• Selcuk University: lead

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: February 14, 2022
• Study Start: February 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: November 1, 2022
• Last Updated: February 14, 2022

Record last verified: 2022-02