NCT06627660

Brief Summary

We hypothesized that manual valsalva maneuver prevent incidence of postoperative laryngospasm after supraglottoplasty for cases of congenital laryngomalacia. Primary outcome: Incidence of postoperative stridor and laryngospasm Secondary outcome: incidence of reintubation, postoperative hemodynamics, duration of postoperative ICU and hospital stay

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 4, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

October 6, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

October 4, 2024

Status Verified

October 1, 2024

Enrollment Period

3 months

First QC Date

October 3, 2024

Last Update Submit

October 3, 2024

Conditions

LaryngomalaciaLaryngospasm

Keywords

VALSALVA MANEUVERPostoperative LaryngospasmSupraglottoplasty

Outcome Measures

Primary Outcomes (1)

  • Incidence of laryngospasm

    24 HOURS

Secondary Outcomes (4)

  • incidence of reintubation

    24 HOURS

  • Postoperative oxygen saturation measurement

    1 HOUR

  • Incidence of postoperative nausea and vomiting

    24 HOURS

  • Duration of postoperative hospital stay

    24 HOURS

Study Arms (2)

Group C

NO INTERVENTION

Control group

Group V

ACTIVE COMPARATOR

Repeated Valsalva maneuver will be done after recovery from anesthesia

Procedure: Valsalva maneuver

Interventions

Valsalva maneuverPROCEDURE

Closure of the nose and mouth during expiration for 20 sec

Group V

Eligibility Criteria

Age1 Month - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Infants and children ASA I or II aging from 1 month age - 6 years undergoing supraglottoplasty

You may not qualify if:

  • Parents refusal.
  • Patients with increased ICP
  • Patients with increased IOP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Kumar CM, Van Zundert AAJ. Intraoperative Valsalva maneuver: a narrative review. Can J Anaesth. 2018 May;65(5):578-585. doi: 10.1007/s12630-018-1074-6. Epub 2018 Jan 24.

    PMID: 29368315BACKGROUND

  • Ramprasad VH, Ryan MA, Farjat AE, Eapen RJ, Raynor EM. Practice patterns in supraglottoplasty and perioperative care. Int J Pediatr Otorhinolaryngol. 2016 Jul;86:118-23. doi: 10.1016/j.ijporl.2016.04.039. Epub 2016 May 3.

    PMID: 27260594BACKGROUND

  • Alalami AA, Ayoub CM, Baraka AS. Laryngospasm: review of different prevention and treatment modalities. Paediatr Anaesth. 2008 Apr;18(4):281-8. doi: 10.1111/j.1460-9592.2008.02448.x.

    PMID: 18315632BACKGROUND

  • Hernández-Cortez E. Update on the management of laryngospasm. J Anesth Crit Care Open Access. 2018;8(2):1-6.

    BACKGROUND

  • Birlie Chekol W, Yaregal Melesse D. Incidence and Associated Factors of Laryngospasm among Pediatric Patients Who Underwent Surgery under General Anesthesia, in University of Gondar Compressive Specialized Hospital, Northwest Ethiopia, 2019: A Cross-Sectional Study. Anesthesiol Res Pract. 2020 Jan 24;2020:3706106. doi: 10.1155/2020/3706106. eCollection 2020.

    PMID: 32411216BACKGROUND

  • Oshan V and Robert WM. Anesthesia for complex airway surgery in children. Continuing Education in Anesthesia, Critical care and Pain 2013;13:47-51

    BACKGROUND

MeSH Terms

Conditions

LaryngomalaciaLaryngismus

Interventions

Valsalva Maneuver

Condition Hierarchy (Ancestors)

Cartilage DiseasesMusculoskeletal DiseasesLaryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesConnective Tissue DiseasesSkin and Connective Tissue DiseasesVocal Cord DysfunctionRespiration Disorders

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaRespiratory Physiological Phenomena

Study Officials

  • Ahmed Elshahat Aboelfoutouh, DOCTORAL DEGREE (MD)

    Lecturer of Anesthesia and Surgical Intensive Care - Faculty of medicine - Mansoura university

    PRINCIPAL INVESTIGATOR

  • Rania Elmohamady Elbadrawy, DOCTORAL DEGREE (MD)

    Lecturer of Anesthesia and Surgical Intensive Care- Faculty of medicine - Mansoura university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

SAMEH FATHY ELSHERBINY, DOCTORAL DEGREE (MD)

CONTACT

002-0100-6500748SMFSHERBINY@YAHOO.COM

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: INTERVENTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sameh Mohamed Fathy El-Sherbiny, MD, Assistant Professor at Mansoura Faculty of Medicine

Study Record Dates

First Submitted

October 3, 2024

First Posted

October 4, 2024

Study Start

October 6, 2024

Primary Completion

January 1, 2025

Study Completion

February 1, 2025

Last Updated

October 4, 2024

Record last verified: 2024-10