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Respiratory and Hemodynamics Parameters Response to Positive End-Expiratory Pressure

Response of Respiratory and Hemodynamic Parameters to Positive End-Expiratory Pressure Titration for Mechanically Ventilated Obese Patients: A Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05508997
Acronym
Respiratory
Enrollment
60
Registered
2022-08-19
Start date
2021-12-01
Completion date
2022-06-30
Last updated
2023-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity Associated Disorder

Keywords

Positive end-expiratory pressure titration, Mechanical ventilator, respiratory and hemodynamics parameters, Obese patients, Reverse Trendelenburg Position.

Brief summary

In this study, the sixty mechanically ventilated class I obese patients were divided into two equal groups A and B. group A received RTP position + PEEP protocol, while group B underwent RTP position protocol only. The results showed that the group A protocol has positive effects on the improvement of respiratory mechanics by significant increase the arterial oxygen partial pressure (PaO2) in mmHg to fractional inspired oxygen (FiO2), (PaO2/FiO2 ratio), partial pressure of carbon dioxide (PaCO2), and static compliance (Cstat) parameters. Moreover, a significant decrease in hemodynamics of BP& MAP was measured. While the results of the group B protocol demonstrated a non-significant increase in the PaO2/FiO2 ratio, PaCO2, and Cstat. Besides, non-significant decreases in hemodynamics of blood pressure (BP) & mean arterial blood pressure (MAP) were recorded.

Detailed description

Objective To investigate the effect of the positive end-expiratory pressure (PEEP) titration maneuver with Reverse Trendelenburg Position (RTP) on the respiratory and hemodynamic parameters of mechanically ventilated obese patients. Design Randomized, control trial. Participants Thirty mechanically ventilated obese patients were randomized equally as a group A to receive Reverse Trendelenburg Position (RTP) + Positive End Expiratory Pressure (PEEP) titration, and group (B): receive Reverse Trendelenburg Position (RTP). Intervention After post-operative bariatric surgeries, the sixty mechanically ventilated obese patients immediately receive a PEEP and RTP once before the weaning through the ventilator of the operation to evaluate the response of arterial blood gases before admission to the intensive care unit ICU room. Outcomes The primary outcomes included the respiratory parameters (PaO2/FiO2 ratio, PaCO2, Cstat), and the secondary outcomes included the hemodynamics parameters (systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP)).

Interventions

DEVICErespiratory parameters on mechanical ventilator (PEEP)

The 3rd & 4th phases of operation in the group (A) and (B): Each patient received one single session inside the Operation Room (OR) as one shot of the treatment procedure. Arterial Blood Gases (ABGs) were obtained to measure: 1. Oxygenation by PaO2/FiO2 ratio with constant FiO2 = 100% (oxygen) through the procedure time as a primary outcome. 2. Secondary outcome. * Ventilation by PaCO2 value from ABGs. * Static compliance (Cstat) was measured as the amount of recruitment of alveoli in the lung. * Blood pressure (systolic/diastolic) one of the hemodynamics measurements was measured pre/post the procedure in the two groups.

Sponsors

Heidy F. Ahmed
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

the patients were under general anesthesia didn't know which procedure they received & the outcomes assessor done by my supervisors and didn't know which result related to specific group

Intervention model description

group A receive Reverse Trendelenburg Position (RTP) + Positive End Expiratory Pressure (PEEP) titration, and group (B): receive Reverse Trendelenburg Position (RTP).

Eligibility

Sex/Gender
ALL
Age
40 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Subjects included in this study had the following criteria: 1. Mechanically ventilated obese patients in operation room undergoing upper abdominal surgeries (bariatric) and under general anesthesia. 2. Obese patients with BMI (30-34.9). 3. Age 40-50 years old. 4. Both sexes. 5. Non-smoker. 6. No history of disease affecting the heart & lungs.

Exclusion criteria

* Subjects with any of the following were excluded from the study: 1. Severe head injury. 2. Increase intracranial pressure and who are potentially liable to develop pathologically raised intracranial pressure. 3. Acute pulmonary edema. 4. Barotrauma/volutrauma. 5. Un-drained Pneumothorax/Hemothorax. 6. Flail chest. 7. Low blood pressure (systolic less than 80 mmHg). 8. Oxygen saturation is less than 90%.

Design outcomes

Primary

MeasureTime frameDescription
Respiratory parametersImmediately after the procedure is done in the operating room appears on the patient's monitor & patient arterial blood gases.The primary outcomes included the respiratory parameters partial oxygen pressure, partial carbon dioxide pressure, static compliance fractional oxygen pressure ratio

Secondary

MeasureTime frameDescription
Hemodynamics parametersImmediately after the procedure is done in the operating room appears on the patient's monitor.The secondary outcomes included the hemodynamics parameters (SBP in mmHg, DBP in mmHg, and MAP in mmHg).

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026