The Effect of Prolonged Inspiratory Time on Pulmonary Mechanics in Obese Patients

NCT ID: NCT02961920

Last Updated: 2019-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2019-05-31

Brief Summary

The area of aesthesia-induced atelectasis is much larger in the obese compared with the non-obese, but there may also be more airway closure and impaired matching of ventilation and lung blood flow.

When an anesthetized patient is turned to the prone position, dynamic compliance (Cdyn) decreases and peak airway pressure increases unless the abdomen hangs freely to prevent the abdominal viscera from compromising the diaphragm movement. Although the Wilson frame is designed to allow the abdomen to hang, it partially compresses the anterior abdominal wall and therefore does not allow the abdomen to hang completely, especially in obese patients.

This in turn increases peak airway pressure and decreases Cdyn, oxygenation. This study aimed to investigate the effects of a prolonged I:E ratio (i.e., 1:1) compared with the conventional I:E ratio of 1:2 on respiratory mechanics and hemodynamics during spine surgery in the prone position in obese patients.

We hypothesized that, compared with an I:E ratio of 1:2, a ratio of 1:1 improve oxygenation without hemodynamic instability .

Detailed Description

After written informed consent was obtained from all patients, 50 adult patients were enrolled in the study.

The patients met the following inclusion criteria: (1) body mass index (BMI, weight in kilograms divided by the square of height in metres) > 25 kg/m2; (2) American Society of Anesthesiology (ASA) physical status classification grade I or II (BMI by itself was not used as the basis for the ASA classification); (3) aged 20 - 65 years; and (4) scheduled for elective spine surgery in prone position.

Exclusion Criteria:

• Patients who have severe pulmonary disease:

history of chronic obstructive pulmonary disease (COPD), asthma, or pneumothorax. Patients with haemodynamic instability, hypovolaemia, bronchopleural fistula, The enrolled patients were randomly allocated according to a predetermined allocation sequence to receive an I:E ratio of either 1:1 (group 1:1) or 1:2 (group 1:2).

The allocation sequence with no blocking was generated in an Internet website Standard monitoring techniques, including electrocardiography, pulse oximetry, and noninvasive arterial blood pressure measurement, are applied upon arrival at the operating room.

Anesthesia was induced with intravenous propofol 1.5 mg_kg-1 and rocuronium 0.8 mg_kg-1 was administered intravenously.

After tracheal intubation, volume-controlled ventilation was initiated with an I:E ratio of 1:2 or 1:1, no positive end-expiratory pressure, and a tidal volume of 10 mL per ideal body weight (kg). A respiratory rate was adjusted in order to end-tidal carbon dioxide (EtCO2) of 33 - 36 mmHg during surgery. Anesthesia was maintained with an end-tidal concentration of 2-2.5 vol% sevoflurane in 40% oxygen/air. The bispectral index score was monitored continuously in order to maintain an adequate anesthetic depth and was targeted at a range of 40-60 during surgery.

Radial artery cannulation was conducted for monitoring continuous arterial blood pressure and blood sampling.

Respiratory, hemodynamic, and arterial blood gas data were assessed and recorded at three time points: ten minutes after tracheal intubation in the supine position (T1), 30 min after prone positioning (T2), 90 min after prone positioning(T3). Respiratory data consisted of peak airway pressure, plateau airway pressure, mean airway pressure, static compliance, EtCO2, respiratory rate, and minute volume. Arterial pH, arterial oxygen tension (PaO2), arterial carbon dioxide tension (PaCO2), and lactate level were obtained from arterial blood gas analysis.

Conditions

Hypoxia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

IE ratio 1:1

Set an I(inspiration):E(expiration) ratio1:1 in the mechanical ventilator during spine surgery in the prone position in obese patients.

Group Type: EXPERIMENTAL

IE ratio 1:1

Intervention Type: DEVICE

Set an I:E ratio1:1 in the mechanical ventilator during spine surgery in the prone position in obese patients.

IE ratio 1:2

Set an I(inspiration):E(expiration) ratio1:2 in the mechanical ventilator during spine surgery in the prone position in obese patients.

Group Type: ACTIVE_COMPARATOR

IE ratio 1:2

Intervention Type: DEVICE

Set an I:E ratio1:2 in the mechanical ventilator during spine surgery in the prone position in obese patients.

Interventions

IE ratio 1:1

Set an I:E ratio1:1 in the mechanical ventilator during spine surgery in the prone position in obese patients.

Intervention Type: DEVICE

IE ratio 1:2

Set an I:E ratio1:2 in the mechanical ventilator during spine surgery in the prone position in obese patients.

Intervention Type: DEVICE

Other Intervention Names

one and one; one and two

Eligibility Criteria

Inclusion Criteria

• ASA I-II adult patients scheduled for spine surgery under general anesthesia.
• patient age : greater than 20 years and less than 65years
• Body Mass Index(BMI) >25 kg/m2

Exclusion Criteria

• Patients who have severe pulmonary disease:

history of chronic obstructive pulmonary disease (COPD), asthma, or pneumothorax. Patients with haemodynamic instability, hypovolaemia, bronchopleural fistula, history of cardiopulmonary disease, or previous lung surgery are excluded.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gachon University Gil Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jung Ju Choi

assistance professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kyung Cheon Lee, MD

Role: STUDY_CHAIR

Gachon University Gil Medical Center

Locations

Kyung Cheon Lee

Incheon, , South Korea

Countries

South Korea

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PrIspSp

Identifier Type: -

Identifier Source: org_study_id