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RecruitingNCT06291389Updated Jan 6, 2026

Intraoperative Peak Airway Pressure Changes on Postoperative Pulmonary Function After Muscle Plication

An observational study in Abdominal Compartment Syndrome, sponsored by Al-Azhar University. Recruiting at 1 site in Egypt. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-01-06.

Sponsored by Al-Azhar University · Observational

From the registry’s dates

  • Started Mar 2024; still recruiting 2 years 8 months later.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
20 Years to 50 Years
Sex
All
01

Study summary

An abdominal panniculus excision procedure is known as an abdominoplasty (panniculectomy). Musculofascial plication is a crucial aspect of abdominoplasty, especially for patients with significant divarication of the recti muscles. This study aimed to evaluate the effect of intraoperative changes in peak airway pressure (PAP) after muscle plication on postoperative pulmonary function.

Read the detailed description

Musculofascial plication is a crucial aspect of abdominoplasty, especially for patients with significant divarication of the recti muscles. This surgical procedure involves the removal of surplus skin and fat around the abdomen, known as panneculectomy, and the anterior abdominal wall muscles' laxity being tightened. This study aimed to elucidate the effect of intraoperative changes in PAP after muscle plication on postoperative pulmonary function.

02

Conditions studied

  • Abdominal Compartment Syndrome
03

In context

Intra-Abdominal Hypertension

71 studies on the registry are indexed under Intra-Abdominal Hypertension; 16 are open to participants now.

This study's planned enrollment of 120 is above the median of 98 across 36 observational studies indexed under Intra-Abdominal Hypertension.

Browse Intra-Abdominal Hypertension studies →

Lead sponsor

Al-Azhar University is the lead sponsor of 531 studies on the registry; 172 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

age ranged between 20 and 50 years old,- American Society of Anesthesiologists (ASA) physical status classification I and came for abdominoplasty operation

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • age ranged between 20 and 50 years old,
  • (ASA) physical status classification I
  • came for abdominoplasty operation

Exclusion criteria

Exclusion Criteria:

  • anemia or levels below 11g/dl
  • bleeding problems
  • cardiovascular disorders
  • restrictive and obstructive respiratory disease
  • abdominoplasty without plication.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Intraoperative peak airway pressure (PAP)

    Intraoperative peak airway pressure (PAP) will be observed Pre-plication, Post- plication in supine position and Post- plication in semi-sitting position

    Time frame: 4 hours

Secondary outcomes

  1. Duration of oxygen therapy

    The duration of oxygen therapy will be recorded

    Time frame: 1 week

  2. Post operative Tidal Volume (Vt) (Measured by spirometer)

    The post operative Tidal Volume (Vt) will be measured by spirometer and will be recorded

    Time frame: 24 hours postoperatively

  3. Post operative Respiratory Rate (RR)

    The Post operative Respiratory Rate (RR) will be recorded

    Time frame: 24 hours postoperatively

  4. Hospital stay.

    The Duration of hospital stay will be recorded

    Time frame: 1 week

07

Study locations

1 of 1 sites recruiting
  • Neveen Kohaf
    Tanta, Egypt 11865, Egypt
    Recruiting
    • Haney Bauiomy · Principal investigator
    • Ahmed Abosakaya · Principal investigator
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References and documents

Individual participant data

Plan to share: Yes — Data will be shared upon resealable request from principle investigator

Supporting information: Study protocol, Statistical analysis plan

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2024 (actual). Primary completion is estimated for Dec 2026, 33 months after the start.

Of 20 observational studies under Intra-Abdominal Hypertension, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 26. This study's planned 33 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 26, 2024
First posted
Mar 4, 2024
StartActual
Mar 10, 2024
Primary completionEst.
Dec 15, 2026
CompletionEst.
Dec 15, 2026
Last update
Jan 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06291389
Collaborators
Benha University
Responsible party
Neveen Abd El Maksoad Kohaf (Lecturer of Clinical Pharmacy, Al-Azhar University) — Principal investigator
First posted
Mar 4, 2024
Start date
Mar 10, 2024
Primary completion
Dec 15, 2026 (estimated)
Completion
Dec 15, 2026 (estimated)
Last update
Jan 6, 2026

Study contacts

Neveen Kohaf, Ph.D
Contact
nevenabdo@azhar.edu.eg
+201060383012
Neveen Kohaf, ph.d
principal investigator · Al-Azhar University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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