Trans Alveolar Pressure Measurement as an Index for Lung Recruitment.
Primary Purpose
Hypoxia
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
lung recruitment protocol
Sponsored by
About this trial
This is an interventional treatment trial for Hypoxia focused on measuring post cardiac surgery,, lung recruitment, trans alveolar pressure
Eligibility Criteria
Inclusion Criteria:
- post cardiac surgery hypoxic adult patients
Exclusion Criteria:
- Patients with contraindications for the use of esophageal catheter including esophageal ulcerations, tumors, diverticulitis, bleeding varices, recent esophageal or gastric surgery, sinusitis, epistaxis and recent nasopharyngeal surgery.
- Postoperative severe haemodynamic instability on high inotropic support.
- Ejection fraction less than 35%.
- Severe restrictive or obstructive lung disease.
- Extremes of age (<19 and > 75 years).
- Morbid obese patients with BMI > 40kg/m2.
Sites / Locations
- Alexandria main university hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
hypoxic group
Arm Description
hypoxic patients (hypoxic index less than 250)
Outcomes
Primary Outcome Measures
transalveolar pressure
cmH2O
hypoxic index
Secondary Outcome Measures
dynamic compliance
ml/cmH2O
Full Information
NCT ID
NCT04168151
First Posted
November 13, 2019
Last Updated
January 5, 2021
Sponsor
University of Alexandria
1. Study Identification
Unique Protocol Identification Number
NCT04168151
Brief Title
Trans Alveolar Pressure Measurement as an Index for Lung Recruitment.
Official Title
Efficacy of Trans Alveolar Pressure Measurement as an Index for Lung Recruitment in Post Cardiac Surgery Hypoxic Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
October 10, 2020 (Actual)
Study Completion Date
October 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alexandria
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
the study is conducted on hypoxic adult patients underwent open heart surgery after arrival to the intensive care unit and stabilization of patients' hemodynamics to assess the efficacy of transalveolar pressure measurement as an index for lung recruitment.
Detailed Description
After one hour from the patient's ICU admission and after stabilization of the patient's haemodynamics, alveolar recruitment will be done for hypoxic patients with hypoxic index less than 250.
The recruitment will be started in the adaptive ventilation mode (AVM mode) using modified stepwise staircase recruitment maneuver in which every 2 minutes positive end-expiratory pressure (PEEP) is increased in increments of 2 cmH2O and the driving pressure will be regulated by AVM mode.
The increase in PEEP will be guided by improvement of dynamic compliance, oxygen saturation and transalveolar pressure (PTA) till near overdistention.
Overdistension will be detected if there are decrease in the mean arterial pressure 25% from the base line value reported after stabilization of the patient's haemodynamics, or decreased oxygen saturation or sudden decrease in dynamic compliance, or inspiratory PTA more than15 cm H2O.
Then PEEP is decreased 2 cm H2O every 3 minutes till a decrease expiratory PTA less than 1 cm H2O, or a decrease in dynamic compliance or a decrease in oxygen saturation ≥ 1% from maximum oxygen saturation is observed (the derecruitment point) then return to a PEEP level 2 cm H2O above the derecruitment point (the optimal PEEP).
Alveolar recruitment will be done once.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia
Keywords
post cardiac surgery,, lung recruitment, trans alveolar pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hypoxic group
Arm Type
Experimental
Arm Description
hypoxic patients (hypoxic index less than 250)
Intervention Type
Other
Intervention Name(s)
lung recruitment protocol
Intervention Description
lung recruitment protocol applied to postcardiac surgery hypoxic adult patients with measurement of trans alveolar pressure as an index for lung recruitment
Primary Outcome Measure Information:
Title
transalveolar pressure
Description
cmH2O
Time Frame
1 day
Title
hypoxic index
Time Frame
1 day
Secondary Outcome Measure Information:
Title
dynamic compliance
Description
ml/cmH2O
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
post cardiac surgery hypoxic adult patients
Exclusion Criteria:
Patients with contraindications for the use of esophageal catheter including esophageal ulcerations, tumors, diverticulitis, bleeding varices, recent esophageal or gastric surgery, sinusitis, epistaxis and recent nasopharyngeal surgery.
Postoperative severe haemodynamic instability on high inotropic support.
Ejection fraction less than 35%.
Severe restrictive or obstructive lung disease.
Extremes of age (<19 and > 75 years).
Morbid obese patients with BMI > 40kg/m2.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ibrahim Mabrouk
Organizational Affiliation
University of Alexandria
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ahmed Y Ali, MD
Organizational Affiliation
University of Alexandria
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Amal M Ahmed, MD
Organizational Affiliation
University of Alexandria
Official's Role
Study Director
Facility Information:
Facility Name
Alexandria main university hospital
City
Alexandria
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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