Trans Alveolar Pressure Measurement as an Index for Lung Recruitment.

NCT ID: NCT04168151

Last Updated: 2021-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2020-10-10

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.

Conditions

Hypoxia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

hypoxic group

hypoxic patients (hypoxic index less than 250)

Group Type: EXPERIMENTAL

lung recruitment protocol

Intervention Type: OTHER

lung recruitment protocol applied to postcardiac surgery hypoxic adult patients with measurement of trans alveolar pressure as an index for lung recruitment

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alexandria

OTHER

Sponsor Role: lead

Responsible Party

Ibrahim Mabrouk Ibrahim

assistant lecturer of anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ibrahim Mabrouk

Role: PRINCIPAL_INVESTIGATOR

University of Alexandria

Ahmed Y Ali, MD

Role: STUDY_DIRECTOR

University of Alexandria

Amal M Ahmed, MD

Role: STUDY_DIRECTOR

University of Alexandria

Locations

Alexandria main university hospital

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

68

Identifier Type: -

Identifier Source: org_study_id