NCT04168151

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 19, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2020

Completed
Last Updated

January 7, 2021

Status Verified

January 1, 2021

Enrollment Period

1.6 years

First QC Date

November 13, 2019

Last Update Submit

January 5, 2021

Conditions

Hypoxia

Keywords

post cardiac surgery,lung recruitmenttrans alveolar pressure

Outcome Measures

Primary Outcomes (2)

  • transalveolar pressure

    cmH2O

    1 day

  • hypoxic index

    1 day

Secondary Outcomes (1)

  • dynamic compliance

    1 day

Study Arms (1)

hypoxic group

EXPERIMENTAL

hypoxic patients (hypoxic index less than 250)

Other: lung recruitment protocol

Interventions

lung recruitment protocolOTHER

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

hypoxic group

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • post cardiac surgery hypoxic adult patients

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria main university hospital

Alexandria, Egypt

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ibrahim Mabrouk

    University of Alexandria

    PRINCIPAL INVESTIGATOR

  • Ahmed Y Ali, MD

    University of Alexandria

    STUDY DIRECTOR

  • Amal M Ahmed, MD

    University of Alexandria

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer of anesthesia

Study Record Dates

First Submitted

November 13, 2019

First Posted

November 19, 2019

Study Start

March 1, 2019

Primary Completion

October 10, 2020

Study Completion

October 10, 2020

Last Updated

January 7, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)