Which Ventilatory Strategy is Better for Lung in Upper Abdominal Surgeries?

NCT04872361 | Unknown DMC

• 1 other identifier: MFM-IRB.MD.21.01.412
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

Ventilated Patients especially those undergoing upper abdominal surgeries are prone to lung atelectasis. They are at risk of adverse effects secondary to inadequate lung ventilation. Applied PEEP and Recruitment maneuver are thought to enhance lung aeration under general anesthesia which could be assessed by ultrasound.

Conditions

Anesthesia Induced Atelectasis

Outcome Measures

Primary Outcomes (1)

• Pre-emergence LUS score

  Lung ultrasonography score (LUS score) between groups at the end of surgery (just before emergence) as a lower LUS indicates better lung aeration.

  intraoperative before recovery from anesthesia

Secondary Outcomes (10)

• Lung ultrasonography score (LUS score)

  preoperative, intraoperative for anesthesia duration to 1 hour postoperative

• Heart rate

  preoperative, intraoperative for anesthesia duration to 1 hour postoperative

• Mean blood pressure

  preoperative, intraoperative to 1 hour postoperative

• oxygen saturation

  preoperative, intraoperative to 1 hour postoperative

• End-tidal carbon dioxide tension

  intraoperative for anesthesia duration

Study Arms (3)

Low PEEP

PLACEBO COMPARATOR

Low positive end-expiratory pressure (PEEP) and no recruitment maneuver (RM)

Procedure: Low PEEP; Device: Lung ultrasonogrphy assessment

High PEEP

ACTIVE COMPARATOR

High positive end-expiratory pressure (PEEP)

Procedure: High PEEP; Device: Lung ultrasonogrphy assessment

High PEEP/RM

ACTIVE COMPARATOR

High positive end-expiratory pressure (PEEP) and recruitment maneuver (RM)

Procedure: High PEEP/RM; Device: Lung ultrasonogrphy assessment

Interventions

Low PEEP PROCEDURE

Patients will be ventilated with a PEEP of 4 cm H2O and no RMs throughout the study

Low PEEP

High PEEP PROCEDURE

PEEP of 10 cm H2O will be applied

High PEEP

High PEEP/RM PROCEDURE

PEEP of 10 cm H2O and RM (30 cm H2O for 30 s) immediately after the second lung ultrasonographic examination and repeated every 30 minutes till emergence

High PEEP/RM

Lung ultrasonogrphy assessment DEVICE

The thorax will divided into 12 quadrants, each of them will be assigned a score of 0-3 as 0, normal lung sliding with fewer than three single B lines 1. three or more B lines 2. coalescent B lines 3. consolidated lung. The LUS (0-36) will be calculated with higher scores indicating more aeration loss

High PEEP; High PEEP/RM; Low PEEP

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists' physical status grades I, II, and III.

You may not qualify if:

• Patient refusal.
• Psychiatric diseases.
• Body Mass Index \> 35 Kg/m2.
• Previous intrathoracic procedures.
• History of severe obstructive pulmonary disease.
• History of severe restrictive lung disease.
• Pulmonary arterial hypertension ( systolic pulmonary arterial pressure \>40 mmHg).
• Pregnancy.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, DK, 050, Egypt

Location

Study Officials

• Aboelnour E Badran, MD

  Professor of Anesthesia and Surgical Intensive Care

  STUDY CHAIR

• Hanaa M EL- Bendary, MD

  Assistant Professor of Anesthesia and Surgical Intensive Care

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double-blind (Participant, Outcomes Assessor).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2021
• First Posted: May 4, 2021
• Study Start: May 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: October 1, 2022
• Last Updated: May 4, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: after completing the study and acceptance for publication
• Access Criteria: Sharing Criteria: the data will be accessible to the investigators and PRS administrators with hiding the identifiers for the patients.

Locations

EG (1)