Trans Alveolar Pressure Measurement as an Index for Lung Recruitment.

Efficacy of Trans Alveolar Pressure Measurement as an Index for Lung Recruitment in Post Cardiac Surgery Hypoxic Patients.

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.

Study Overview

• Status: Completed
• Conditions: Hypoxia
• Intervention / Treatment: Other: lung recruitment protocol

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.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Alexandria main university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• post cardiac surgery hypoxic adult patients

Exclusion Criteria:

1. 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.
2. Postoperative severe haemodynamic instability on high inotropic support.
3. Ejection fraction less than 35%.
4. Severe restrictive or obstructive lung disease.
5. Extremes of age (<19 and > 75 years).
6. Morbid obese patients with BMI > 40kg/m2.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: hypoxic group; hypoxic patients (hypoxic index less than 250)	Other: lung recruitment protocol; lung recruitment protocol applied to postcardiac surgery hypoxic adult patients with measurement of trans alveolar pressure as an index for lung recruitment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
transalveolar pressure	cmH2O	1 day
hypoxic index		1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
dynamic compliance	ml/cmH2O	1 day

Collaborators and Investigators

• Sponsor: University of Alexandria
• Investigators: Principal Investigator: Ibrahim Mabrouk, University of Alexandria; Study Director: Ahmed Y Ali, MD, University of Alexandria; Study Director: Amal M Ahmed, MD, University of Alexandria

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): October 10, 2020
• Study Completion (Actual): October 10, 2020

Study Registration Dates

• First Submitted: November 13, 2019
• First Submitted That Met QC Criteria: November 15, 2019
• First Posted (Actual): November 19, 2019

Study Record Updates

• Last Update Posted (Actual): January 7, 2021
• Last Update Submitted That Met QC Criteria: January 5, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: lung recruitment; post cardiac surgery,; trans alveolar pressure
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: 68

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No