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The Role Intraoperative Salbutamol Inhaler in Preventing Atelectasis

11. mai 2026 oppdatert av: Diab Bani Hani, King Abdullah University Hospital

The Role Intraoperative Salbutamol Inhaler Usage as Part of Intraoperative Regimen in Preventing Atelectasis Following Thoracic, Abdominal and Spinal Surgery in Diabetics Population

Atelectasis is considered a common complication in the perioperative period, especially following surgeries under general anesthesia. Postoperative atelectasis could occur anytime during the perioperative period from intraoperative period to 24 hours postoperative and contribute to a variety of other complications, including hypoxemia and pneumonia. In the literature, several methods were utilized to combat this phenomenon, therefore, we investigate the role of intraoperative salbutamol in reducing the incidence of atelectasis. It is well known that salbutamol could be an adjunctive bronchodilator medication used in the intraoperative anesthetic regimens.

Studieoversikt

Status

Har ikke rekruttert ennå

Intervensjon / Behandling

Detaljert beskrivelse

Atelectasis is the collapse or incomplete expansion of the lung or a part of it, resulting in impaired gas exchange and potential hypoxemia. It is a common complication in various clinical settings, particularly after surgery, and can contribute to increased morbidity and prolonged hospital stay. The incidence of atelectasis varies widely depending on the patient population and type of surgical procedure. Postoperative atelectasis is reported in up to 90% of patients undergoing general anesthesia, with higher rates observed in thoracic and upper abdominal surgeries. In pediatric populations, the incidence may range from 10-25%, especially following gastrointestinal or thoracic procedures. Key risk factors include general anesthesia, postoperative pain, obesity, advanced age, smoking, prolonged immobility, neuromuscular disorders, and mechanical ventilation. These factors contribute to reduced diaphragmatic motion, impaired mucociliary clearance, and decreased alveolar ventilation. There are several causes of atelectasis in the postoperative period which results from a combination of factors that impair normal lung expansion and ventilation as reduced functional residual capacity as general anesthesia decreases FRC below closing volume, especially in dependent lung areas, promoting alveolar collapse. Impaired diaphragmatic function as pain and muscle relaxation reduce diaphragmatic motion, limiting lung inflation post-surgery. In addition, mucus retention due to suppressed cough reflex and ciliary function leads to resorptive (obstructive) atelectasis. Another important mechanism for atelectasis is airway obstruction and reflex bronchospasm. Management of atelectasis depends mainly on prevention and lung re-expansion strategies and it is divided according to period. In the preoperative period, smoking cessation at least 4-8 weeks before surgery reduces risk and patient education on deep breathing and coughing exercises. In the intraoperative period, the use of lung-protective ventilation as low tidal volumes with adequate PEEP (positive end-expiratory pressure) to prevent alveolar collapse [5]. Recruitment maneuvers during surgery to reopen collapsed alveoli. Furthermore, the use of postoperative nebulizers such as bronchodilator (salbutamol) and steroids has been shown to benefit those patients. Our hypothesis is that intraoperative salbutamol inhaler will lead to a reduction in the incidence and severity of atelectasis especially in diabetic patients. Therefore our primary aim of the study is to examine the incidence of atelectasis in diabetic patients compared to standard anesthesia and surgery techniques in our institution.in addition, outcomes such as severity of the atelectasis, overall hospital stay, side effects of salbutamol, hypoxia and pneumonia.

Studietype

Intervensjonell

Registrering (Antatt)

80

Fase

  • Tidlig fase 1

Kontakter og plasseringer

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Studiekontakt

Studiesteder

      • Irbid, Jordan
        • King Abdullah University Hospital
        • Ta kontakt med:
          • Principal Investigator Principal Investigator

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • The study will include patients aged 18-70 years
  • American Society of Anesthesiologists (ASA) physical status of I or II
  • Will undergo thoracic, abdominal or spinal surgery

Exclusion Criteria:

  • cardiac conditions other than hypertension like arrhythmia
  • previous cardiac surgeries and valvular heart diseases

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: salbutamol group for diabetic patients
for diabetic patients
-4 puffs of salbutamol (each puff = 100 µg, total dose 200-400 µg)
Ingen inngripen: no intervention for diabetic
Eksperimentell: salbutamol group for non-diabetic patients
for non-diabetic patients
-4 puffs of salbutamol (each puff = 100 µg, total dose 200-400 µg)
Ingen inngripen: no intervention for non-diabetic patients
for non-diabetic patients

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Postoperative atelectasis (vital signs)
Tidsramme: 5 months
All patients will undergo a thorough medical history, appropriate physical examination, and relevant investigations according to their clinical needs. Particular attention will be given to vital signs, especially pulse oximetry.
5 months
Postoperative atelectasis (x-ray)
Tidsramme: 5 months
All patients will undergo a chest X-ray to investigate for atelectasis.
5 months
Postoperative atelectasis (blood gases)
Tidsramme: 5 months
Postoperatively blood gases will be assessed to investigate for atelectasis. This will be done through arterial blood gases sample at 24 hours postoperative.
5 months

Samarbeidspartnere og etterforskere

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Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juni 2026

Primær fullføring (Antatt)

1. oktober 2026

Studiet fullført (Antatt)

1. desember 2026

Datoer for studieregistrering

Først innsendt

3. mai 2026

Først innsendt som oppfylte QC-kriteriene

11. mai 2026

Først lagt ut (Faktiske)

15. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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