Respiratory and Hemodynamics Parameters Response to Positive End-Expiratory Pressure (Respiratory)

February 13, 2023 updated by: Heidy F. Ahmed

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)).

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt, 12556
        • Al Kasr Al Aini Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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%.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Positive End Expiatory Pressure + Reverse Trendelenburg Position
Group A received the procedures of the physiotherapy part by applying proper positioning for better oxygenation and ventilation (Reverse Trendelenburg Position), which is the patient laid supine with the head up 30 degrees higher than the feet & received the recruitment maneuver (RM) by Positive End Expiratory Pressure (PEEP) titration
Device: respiratory 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.
Active Comparator: Reverse Trendelenburg Position

Group B received only the procedures of the physiotherapy part at the 3rd phase of operation by applying proper positioning for better oxygenation and ventilation (Reverse Trendelenburg Position), in which the patient laid supine with the head at 15-30 degrees higher than the feet to unload the weight of intra-abdominal contents from the diaphragm, this position:

  1. Increase pulmonary compliance, functional residual capacity (FRC), and oxygenation.
  2. Allows easier ventilation.
  3. This position called safe apnea time allows time to secure the airway before desaturation for a 20-minute positioning time.
Device: respiratory 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory parameters
Time Frame: Immediately 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
Immediately after the procedure is done in the operating room appears on the patient's monitor & patient arterial blood gases.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemodynamics parameters
Time Frame: Immediately 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).
Immediately after the procedure is done in the operating room appears on the patient's monitor.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidy F. Ahmed

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Actual)

June 17, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

August 11, 2022

First Submitted That Met QC Criteria

August 18, 2022

First Posted (Actual)

August 19, 2022

Study Record Updates

Last Update Posted (Actual)

February 15, 2023

Last Update Submitted That Met QC Criteria

February 13, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • P.T.REC/012/001827

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected individual participant data (IPD), all IPD that underlie results in a publication.

IPD Sharing Time Frame

In the next month of registration.

IPD Sharing Access Criteria

Information will be available upon request through the following e-mail: heidy.fouad@gmail.com.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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