NCT05325463

Brief Summary

The investigators hypothesized that an ultrasound-guided lung recruitment maneuvers would be more effective in preventing postoperative atelectasis than conventional alveolar recruitment after surgical correction of idiopathic adolescent scoliosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

April 10, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 13, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

May 1, 2024

Status Verified

April 1, 2024

Enrollment Period

2 years

First QC Date

April 6, 2022

Last Update Submit

April 30, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • the incidence of atelectasis

    the incidence of postoperative atelectasis in post-anaesthesia care unit

    postoperative first 2 hours

Study Arms (2)

conventional

EXPERIMENTAL
Procedure: conventional lung recruitment

ultrasound- guided

ACTIVE COMPARATOR
Procedure: ultrasound- guided lung recruitment

Interventions

The recruitment maneuver will be performed by pressure controlled mode maintaining a steady airway pressure of 15 cmH2O, with 5 cmH2O increments in positive end-expiratory pressure (PEEP) until a peak pressure of 30 cmH2O will be achieved. Each PEEP level will be maintained for 5 sec. The peak airway pressure will be maintained for 10 sec or five breaths and subsequently reduced, followed by maintenance with the previous ventilator settings.

conventional

The recruitment maneuver will be performed under ultrasound guidance until no collapsed lung area was visible. The strategy to increase the airway pressure will be the same as that for the conventional maneuver, although the maximal pressure limit was 40 cmH2O.

ultrasound- guided

Eligibility Criteria

Age11 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients scheduled for elective correction of AIS
  • aged between 10 and 25 years old
  • American society of anesthesiologists (ASA) class I \& II
  • both genders

You may not qualify if:

  • Morbidly obese patients
  • patients with previous thoracic surgery
  • upper or lower airway infection within 2 weeks before the surgery
  • abnormal preoperative chest x-ray findings including atelectasis, pneumothorax, pleural effusion or pneumonia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine, Tanta university

Tanta, El Gharbyia, 31111, Egypt

Location

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

April 6, 2022

First Posted

April 13, 2022

Study Start

April 10, 2022

Primary Completion

April 1, 2024

Study Completion

April 30, 2024

Last Updated

May 1, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations