Trans Alveolar Pressure Measurement as an Index for Lung Recruitment.

Sponsor

University of Alexandria (Other)

Overall Status

Completed

CT.gov ID

NCT04168151

Collaborator

(none)

Enrollment

Location

Arm

19.4

Actual Duration (Months)

3.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hypoxia	Other: lung recruitment protocol	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

62 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2019

Actual Primary Completion Date :

Oct 10, 2020

Actual Study Completion Date :

Oct 10, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

transalveolar pressure [1 day]
cmH2O
hypoxic index [1 day]

Secondary Outcome Measures

dynamic compliance [1 day]
ml/cmH2O

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alexandria main university hospital	Alexandria		Egypt

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ibrahim Mabrouk Ibrahim, assistant lecturer of anesthesia, University of Alexandria

ClinicalTrials.gov Identifier:

NCT04168151

Other Study ID Numbers:

First Posted:

Nov 19, 2019

Last Update Posted:

Jan 7, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ibrahim Mabrouk Ibrahim, assistant lecturer of anesthesia, University of Alexandria

post cardiac surgery,

lung recruitment

trans alveolar pressure

Additional relevant MeSH terms:

Hypoxia

Study Results

No Results Posted as of Jan 7, 2021