Ultrasound Evaluation of Preventive Measures for Postoperative Lung Atelectasis After Surgery

NCT06654778 | Completed

• 1 other identifier: AZAST/MD/209/MARCH/2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

the aim of this prospective randomized blinded clinical study will be to assess the ultrasound evaluation of different preventive measures of post operative lung atelectasis in abdominal surgeries; these measures include ventilation and fluid measures

Conditions

Pulmonary Atelectasis, Postoperative

Keywords

lung ultrasound; lung Atelectasis; Atelectasis; Pulmonary Atelectasis; pressure controlled ventilation - volume guarantee (PCV- VG); positive end-expiratory pressure (PEEP); lung recruitment maneuver; restrictive fluid strategies

Outcome Measures

Primary Outcomes (1)

• Lung ultrasound assessment of postoperative pulmonary atelectasis at the end of surgery

  Lung ultrasound assessment of postoperative pulmonary atelectasis at the end of surgery. The Lung Ultrasound Score (LUS): the key points based on ultrasound findings: I. 0 points: (N) Normal aeration (presence of lung sliding with A-lines or \<2 separate B-lines). II. 1 point: (B1) Moderate loss of lung aeration (≥3 well-defined B lines). III. 2 points: (B2) Severe loss of lung aeration (coalescing B-lines). IV. 3 points: (C) Complete loss of lung aeration (pulmonary consolidations). Total Score: points will be distributed according to the worst ultrasound pattern observed: N = 0, B1 lines = 1, B2 lines = 2, C = 3. The LUS score ranging between 0 and 36 was calculated as the sum of points.

  at the end of surgery before emergence from GA.

Secondary Outcomes (7)

• Lung ultrasound assessment

  before induction of general anesthesia

• Lung ultrasound assessment

  5 minutes post induction of general anesthesia

• Lung ultrasound assessment

  15 minutes after patients arrive to PACU

• Lung ultrasound assessment

  60 minutes after patients arrive to PACU

• arterial blood gases

  5 minutes post induction of general anesthesia

Study Arms (3)

Group I: PEEP

EXPERIMENTAL

Patients will be ventilated with PEEP of 8 cm H2O and fluid management: 500 ml of Ringer's lactate in the recovery room before surgery and Ringer's lactate at a rate of 4 mL/kg/hour from the beginning to the end of the surgery.

Other: PEEP

Group II: PEEP/RM

EXPERIMENTAL

Patients will be ventilated with PEEP of 8 cm H2O, and then RM (30 cm H2O for 30 s) will be applied immediately after the second LUS examination and repeated every 30 minutes till emergence and fluid management: 500 ml of Ringer's lactate in recovery room before surgery and Ringer's lactate at a rate of 4 mL/kg/hour from the beginning to the end of the surgery

Other: PEEP/RM

Group III: PEEP/RM/RF

EXPERIMENTAL

Patients will be ventilated with PEEP of 8 cm H2O, and then RM (30 cm H2O for 30 s) will be applied immediately after the second LUS examination and repeated every 30 minutes till emergence and restrictive fluid management (RF). Ringer's lactate at a rate of 3 mL/kg/hour from the beginning to the end of the surgery

Other: PEEP/RM/RF

Interventions

PEEP OTHER

Patients will be ventilated with PEEP of 8 cm H2O and fluid management: 500 ml of Ringer's lactate in the recovery room before surgery and Ringer's lactate at a rate of 4 mL/kg/hour from the beginning to the end of the surgery.

Group I: PEEP

PEEP/RM OTHER

Patients will be ventilated with PEEP of 8 cm H2O, and then RM (30 cm H2O for 30 s) will be applied immediately after the second LUS examination and repeated every 30 minutes till emergence and fluid management: 500 ml of Ringer's lactate in recovery room before surgery and Ringer's lactate at a rate of 4 mL/kg/hour from the beginning to the end of the surgery

Group II: PEEP/RM

PEEP/RM/RF OTHER

Patients will be ventilated with PEEP of 8 cm H2O, and then RM (30 cm H2O for 30 s) will be applied immediately after the second LUS examination and repeated every 30 minutes till emergence and restrictive fluid management (RF). Ringer's lactate at a rate of 3 mL/kg/hour from the beginning to the end of the surgery

Group III: PEEP/RM/RF

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA physical status I or II, of either gender.
• BMI \< 40
• Age 30-60 years
• scheduled for elective abdominal surgeries

You may not qualify if:

• Patient refusal
• American Society of Anesthesiologists (ASA) physical status classification system more than II
• BMI \> 40 .
• Psychiatric disorders
• History of chest disorders such as asthma and obstructive pulmonary disease (COPD).
• History of Previous Thoracic Procedures.
• Pregnancy

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-Azhar university

Asyut, Egypt

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hamed M Wally Allah

  Al-Azhar University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer in Anesthesia, Intensive Care and pain management department, Faculty of Medicine, Al-Azhar University (Assiut)

Model Details: The patients will be assigned into three equal groups of 20 patients each: 1. Group I: PEEP of 8 cm H2O and fluid management: 500 ml + 4 mL/kg/hour Ringer's lactate 2. Group II: PEEP/RM group, addition of RM (30 cm H2O for 30 s) 3. Group III: PEEP/RM group and restricted fluid management 3 mL/kg/hour Ringer's lactate A total sample size of 60 patients will be involved.

Study Record Dates

• First Submitted: October 20, 2024
• First Posted: October 23, 2024
• Study Start: December 8, 2024
• Primary Completion: December 19, 2025
• Study Completion: December 19, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

EG (1)